Fenwal Inc

FDA Filings

This page includes the latest FDA filings for Fenwal Inc. Currently, you will find the latest 100 filings for Premarket Notifications, Premarket Applications, De Novo Applications, and GUDID registrations.

Fenwal Inc holds import registrations or U.S. agent authorizations in conjunction with the following organizations:

FDA Registration(s)
Registration Number3004548776
FEI Number3004548776
NameFENWAL, INC.
Owner & OperatorFresenius Kabi AG
Contact Address-
61346 Bad Homburg DE-NOTA NONE DE
Registration Status1
Initial ImporterY
Registration Expiration2020-04-25
Registration Address3 CORPORATE DR STE 300
LAKE ZURICH, IL 60047 US
Establishment Type
  • Complaint File Establishment per 21 CFR 820.198
  • Develop Specifications But Do Not Manufacture At This Facility

FDA Filings

Device
Company
DeviceDate
FENWAL, INC.
 Transfer Pack 4R20042023-04-21
Fenwal, Inc., Fenwal International, Inc.
Prescription Medication2023-03-06
Fenwal, Inc., Fresenius Kabi Horatev CZ s.r.o.
Prescription Medication2022-11-24
Fenwal, Inc., Fresenius Medical Care de Mexico, S.A. de C.V.
Prescription Medication2022-11-08
Fenwal, Inc., Fenwal International, Inc.
Prescription Medication2022-11-03
Fenwal, Inc., Fenwal International, Inc.
Prescription Medication2022-11-02
Fenwal, Inc., Fresenius Kabi Horatev CZ s.r.o.
Prescription Medication2022-06-24
FENWAL, INC.
 Transfer Pack 4R20012022-06-17
FENWAL, INC.
 Transfer Pack 4R20322022-06-17
Fenwal, Inc., Fenwal International, Inc.
Prescription Medication2022-06-04
Fenwal, Inc., Fenwal International, Inc.
Prescription Medication2022-06-02
Fenwal, Inc., Fenwal International, Inc.
Prescription Medication2022-06-01
Fenwal, Inc., Fenwal International, Inc.
Prescription Medication2022-02-12
Fenwal, Inc., Fenwal International, Inc.
Prescription Medication2021-12-02
Fenwal, Inc., Fenwal International, Inc.
Prescription Medication2021-12-01
Fenwal, Inc.
Prescription Medication2021-11-30
Fenwal, Inc., Fenwal International, Inc.
Prescription Medication2021-06-26
Fenwal, Inc.
Prescription Medication2021-06-26
Fenwal, Inc., Fenwal International, Inc.
Prescription Medication2021-06-18
Fenwal, Inc.
Prescription Medication2021-06-18
Fenwal, Inc., Fenwal International, Inc.
Prescription Medication2021-06-18
Fenwal, Inc., Fenwal International, Inc.
Prescription Medication2021-06-18
Fenwal, Inc., Fenwal International, Inc.
Prescription Medication2021-06-17
Fenwal, Inc., Fenwal International, Inc.
Prescription Medication2021-06-17
Fenwal, Inc., Fresenius Medical Care de Mexico, S.A. de C.V.
Prescription Medication2021-01-08
Fenwal, Inc., Fenwal International, Inc.
Prescription Medication2020-12-01
Fenwal, Inc., Fenwal International, Inc.
Prescription Medication2020-12-01
Fenwal, Inc., Fenwal International, Inc.
Prescription Medication2020-12-01
Fenwal, Inc., Fenwal International, Inc.
Prescription Medication2020-12-01
Fenwal, Inc., Fresenius Medical Care de Mexico, S.A. de C.V.
Prescription Medication2020-07-17
Fenwal Inc
Automated Blood Cell Separators2020-06-10
FENWAL, INC. [Fresenius Kabi AG]
CATSmart2020-01-24
FENWAL, INC. [Fresenius Kabi AG]
CATSmart2020-01-24
FENWAL, INC. [Fresenius Kabi AG]
AMICUS Separator System2019-12-09
FENWAL, INC. [Fresenius Kabi AG]
AMICUS Separator System2019-12-09
Fenwal, Inc., Fenwal International, Inc.
Prescription Medication2019-11-28
Fenwal, Inc., Fenwal International, Inc.
Prescription Medication2019-11-27
Fenwal, Inc.
Prescription Medication2019-11-27
Fenwal, Inc., Fenwal International, Inc.
Prescription Medication2019-11-27
Fenwal, Inc., Fenwal International, Inc.
Prescription Medication2019-11-27
Fenwal, Inc.
Prescription Medication2019-11-26
Fenwal, Inc.
Prescription Medication2019-11-26
Fenwal, Inc.
Prescription Medication2019-11-26
Fenwal, Inc., Fenwal International, Inc.
Prescription Medication2019-11-26
Fenwal, Inc., Fenwal International, Inc.
Prescription Medication2019-11-26
Fenwal, Inc.
Prescription Medication2019-11-26
Fenwal, Inc.
Prescription Medication2019-11-26
Fenwal, Inc.
Prescription Medication2019-11-26
Fenwal, Inc., Fenwal International, Inc.
Prescription Medication2019-11-22
Fenwal, Inc.
Prescription Medication2019-11-22
Fenwal, Inc.
Prescription Medication2019-11-22
Fenwal, Inc.
Prescription Medication2019-11-22
Fenwal, Inc., Fenwal International
Prescription Medication2019-11-22
Fenwal, Inc.
Prescription Medication2019-11-22
Fenwal, Inc.
Prescription Medication2019-11-21
Fenwal, Inc., Fenwal International, Inc.
Prescription Medication2019-11-21
Fenwal, Inc.
Prescription Medication2019-11-21
Fenwal, Inc., Fenwal International, Inc.
Prescription Medication2019-11-21
Fenwal, Inc.
Prescription Medication2019-11-21
Fenwal, Inc., Fenwal International, Inc.
Prescription Medication2019-11-20
Fenwal, Inc., Fenwal International, Inc.
Prescription Medication2019-11-20
Fenwal, Inc., Fenwal International, Inc.
Prescription Medication2019-11-20
Fenwal, Inc., Fenwal International, Inc.
Prescription Medication2019-11-19
Fenwal, Inc., Fenwal International, Inc.
Prescription Medication2019-11-19
Fenwal, Inc.
Prescription Medication2019-11-19
Fenwal, Inc., Fenwal International, Inc.
Prescription Medication2019-11-19
Fenwal, Inc., Fenwal International, Inc.
Prescription Medication2019-11-19
Fenwal, Inc.
Prescription Medication2019-11-19
Fenwal, Inc., Fenwal International, Inc.
Prescription Medication2019-11-19
FENWAL, INC.
 4C2243 4C22432019-11-08
FENWAL, INC.
 4C2240 4C22402019-11-08
FENWAL, INC.
 Transfer Pack 4R20232019-11-08
FENWAL, INC.
 Transfer Pack 4R20142019-11-08
FENWAL, INC.
 Transfer Pack 4R20272019-11-08
FENWAL, INC.
 4C2160 4C21602019-11-08
FENWAL, INC.
 4C2161 4C21612019-11-08
FENWAL, INC.
 Transfer Pack 4R20242019-11-08
FENWAL, INC. [Fresenius Kabi AG]
Aurora Plasmapheresis System Software Version 2.12019-10-04
FENWAL, INC. [Fresenius Kabi AG]
Plasmalink Bottle with Locking Luer Adapter2019-10-04
Fenwal, Inc., Fenwal International, Inc.
Prescription Medication2019-08-23
FENWAL, INC. [Fresenius Kabi AG]
Alyx Component Collection System2019-07-25
Fenwal, Inc., Fenwal International, Inc.
Prescription Medication2019-06-07
Fenwal, Inc.
InterSol2019-06-05
Fenwal, Inc., Fenwal International, Inc.
Prescription Medication2019-05-10
Fenwal, Inc., Fenwal International, Inc.
Prescription Medication2019-05-09
Fenwal, Inc., Fenwal International, Inc.
Prescription Medication2019-05-01
Fenwal, Inc., Fenwal International, Inc.
Prescription Medication2019-04-24
Fenwal, Inc., Fenwal International, Inc.
Prescription Medication2019-04-24
Fenwal, Inc., Fenwal International, Inc.
Prescription Medication2019-04-16
FENWAL, INC. [Fresenius Kabi AG]
Plasmalink Bottle with Locking Luer Adapter2019-04-08
FENWAL, INC. [Fresenius Kabi AG]
Glycerolyte 57 Solution2019-04-08
Fenwal, Inc., Fenwal International, Inc.
Prescription Medication2019-03-30
Fenwal, Inc.
Prescription Medication2019-03-12
FENWAL, INC. [Fresenius Kabi AG]
Waste Transfer Set2018-12-20
FENWAL, INC. [Fresenius Kabi AG]
Blood Component Filter Set with Vented Spike and Luer Adapter2018-12-20
FENWAL, INC. [Fresenius Kabi AG]
AMICUS Separator System2018-12-20
FENWAL, INC. [Fresenius Kabi AG]
AMICUS Exchange Kit - Therapeutics2018-12-20
FENWAL, INC. [Fresenius Kabi AG]
Waste Transfer Set2018-12-20
FENWAL, INC. [Fresenius Kabi AG]
Blood Component Filter Set with Vented Spike and Luer Adapter2018-12-20
FENWAL, INC. [Fresenius Kabi AG]
AMICUS Separator System2018-12-20
FENWAL, INC. [Fresenius Kabi AG]
AMICUS Exchange Kit - Therapeutics2018-12-20
FENWAL, INC.
 Fenwal DXT Relay 5S98042018-12-07
FENWAL, INC. [Fresenius Kabi AG]
Aurora Xi Plasmapheresis System, Software Version 1.22018-11-29
FENWAL, INC.
 Fenwal DXT Relay Release 2.2 5S98032018-11-08
FENWAL, INC.
 4C2468 4C24682018-07-06
FENWAL, INC.
 4C2223 4C22232018-07-06
FENWAL, INC.
 Leukoconnect 4C43002018-07-06
FENWAL, INC.
 4C2300 4C23002018-07-06
FENWAL, INC.
 4C4502 4C45022018-07-06
FENWAL, INC.
 ALYX™ 2RBC-LR Kit 4R57202018-07-06
FENWAL, INC.
 ALYX 2RBC LR Kit with Saline Spike 4R57422018-07-06
FENWAL, INC.
 ALYX Plasma Kit 4R57302018-07-06
FENWAL, INC.
 ALYX™ RBC/Plasma Kit 4R57002018-07-06
FENWAL, INC.
 4C2498H 4C2498H2018-03-29
FENWAL, INC.
 Apheresis Needle with MASTERGUARD Protector 4R24412018-03-29
FENWAL, INC.
 4R2422 4R24222018-03-29
FENWAL, INC.
 Apheresis Needle with MASTERGUARD™ Protector 4R24402018-03-29
FENWAL, INC. [Fresenius Kabi AG]
Amicus Separator System2018-01-02
FENWAL, INC. [Fresenius Kabi AG]
sanabelle HME-A2 artificial nose for infants; sanabelle HME-A7 artificial nose with valve2017-12-22
FENWAL, INC. [Fresenius Kabi AG]
DXT2017-10-17
FENWAL, INC. [Fresenius Kabi AG]
Aurora Xi Plasmapheresis System2017-10-12
Fenwal Inc
Automated Blood Cell Separators2017-09-14
FENWAL, INC. [Fresenius Kabi AG]
Bone Marrow Collection Stand2017-08-15
FENWAL, INC. [Fresenius Kabi AG]
Bone Marrow Collection Kit with Flexible Pre-Filter and Inline Filters2017-08-15
FENWAL, INC. [Fresenius Kabi AG]
Platelet Storage Container2017-05-16
FENWAL, INC. [Fresenius Kabi AG]
Amicus Apheresis Kit Single Needle Functionally Closed Kit2017-05-16
FENWAL, INC. [Fresenius Kabi AG]
Amicus Apheresis Kit Single Needle Closed Kit2017-05-16
FENWAL, INC. [Fresenius Kabi AG]
Amicus Apheresis Kit Single Needle Closed Kit with Platelet Additive Solution (PAS) Connector2017-05-16
FENWAL, INC. [Fresenius Kabi AG]
Amicus Apheresis Kit Single Needle Advanced Kit2017-05-16
FENWAL, INC. [Fresenius Kabi AG]
Amicus Apheresis Kit Double Needle MNC Kit2017-05-16
FENWAL, INC. [Fresenius Kabi AG]
Amicus Apheresis Kit Double Needle Functionally Closed Kit2017-05-16
FENWAL, INC. [Fresenius Kabi AG]
Amicus Apheresis Kit Double Needle Closed Kit2017-05-16
FENWAL, INC. [Fresenius Kabi AG]
Amicus Apheresis Kit Double Needle Closed Kit with Platelet Additive Solution (PAS) Connector2017-05-16
FENWAL, INC. [Fresenius Kabi AG]
Amicus Apheresis Kit Double Needle Advanced Kit2017-05-16
FENWAL, INC. [Fresenius Kabi AG]
Alyx Component Collection System2017-04-26
Fenwal Inc
Automated Blood Cell Separators2017-04-03
Fenwal, Inc.
ADSOL RED CELL PRESERVATION SYSTEM IN PLASTIC CONTAINER (PL 146 PLASTIC)2017-02-28
Fenwal, Inc.
ADSOL RED CELL PRESERVATION SYSTEM IN PLASTIC CONTAINER (PL 146 PLASTIC)2017-02-28
Fenwal, Inc.
ADSOL RED CELL PRESERVATION SYSTEM IN PLASTIC CONTAINER (PL 146 PLASTIC)2017-02-28
Fenwal, Inc.
CPD/ADSOL2017-02-28
Fenwal, Inc.
ADSOL RED CELL PRESERVATION SYSTEM IN PLASTIC CONTAINER (PL 146 PLASTIC)2017-02-28
FENWAL, INC. [Fresenius Kabi AG]
AMICUS Separator System2016-12-14
FENWAL, INC. [Fresenius Kabi AG]
AMICUS Separator System2016-12-14
FENWAL, INC. [Fresenius Kabi AG]
PLASMACELL Xi Disposable Set2016-09-27
FENWAL, INC. [Fresenius Kabi AG]
Aurora Xi Plasmapheresis System2016-09-27
FENWAL, INC. [Fresenius Kabi AG]
CATSmart System2016-09-22
FENWAL, INC. [Fresenius Kabi AG]
Aurora Software Version 1.3 Upgrade Kit2016-08-02
FENWAL, INC. [Fresenius Kabi AG]
Aurora Plasmapheresis System2016-08-02
FENWAL, INC. [Fresenius Kabi AG]
Bone Marrow Collection Stand2016-07-11
FENWAL, INC. [Fresenius Kabi AG]
Bone Marrow Collection Kit2016-07-11
FENWAL, INC. [Fresenius Kabi AG]
Bone Marrow Collection Container2016-07-11
FENWAL, INC. [Fresenius Kabi AG]
Fenwal Amicus Single Needle Advanced Kit2016-06-30
FENWAL, INC. [Fresenius Kabi AG]
Fenwal Amicus Double Needle Advanced Kit2016-06-30
FENWAL, INC. [Fresenius Kabi AG]
Fenwal AMICUS Apheresis Kit - Single Needle Functionally Closed Kit2015-11-25
FENWAL, INC. [Fresenius Kabi AG]
Fenwal AMICUS Apheresis Kit - Double Needle Functionally Closed Kit2015-11-25
FENWAL, INC. [Fresenius Kabi AG]
Amicus Apheresis Kit - Single Needle2015-11-25
FENWAL, INC. [Fresenius Kabi AG]
AMICUS Apheresis Kit - Single Needle with Platelet Additive Solution Connector2015-11-25
FENWAL, INC. [Fresenius Kabi AG]
AMICUS Apheresis Kit - Double Needle with Platelet Additive Solution Connector2015-11-25
FENWAL, INC. [Fresenius Kabi AG]
AMICUS Apheresis Kit - Double Needle with Inlet Line Sampling2015-11-25
FENWAL, INC. [Fresenius Kabi AG]
Y-BLOOD SET 170 MICRONFILTER NEEDLEFREE2015-11-13
FENWAL, INC. [Fresenius Kabi AG]
MICROBORE EXTENSION, 4-WAY STOPCOCK2015-11-13
FENWAL, INC. [Fresenius Kabi AG]
EXTENSION, FLL, 0.2 MICRON FILTER2015-11-13
FENWAL, INC. [Fresenius Kabi AG]
EXTENSION, CHECK VALVE, 3GANG VALVES2015-11-13
FENWAL, INC. [Fresenius Kabi AG]
EXTENSION, 3GANG ASV, NEEDLEFREE VALVES2015-11-13
FENWAL, INC. [Fresenius Kabi AG]
EXTENSION, 2GANG VALVES, Y-INJ SITE2015-11-13
FENWAL, INC. [Fresenius Kabi AG]
EXTENSION, 1.2 MICRON FILTER, SLIDE CLMP2015-11-13
FENWAL, INC. [Fresenius Kabi AG]
EXTENSION 0.2 MICRON FILTER, NEEDLEFREE2015-11-13
FENWAL, INC. [Fresenius Kabi AG]
BLOOD SET 170 MICRON, PUMP, NEEDLEFREE2015-11-13
FENWAL, INC. [Fresenius Kabi AG]
BLOOD SET 170 MICRON, 2 NEEDLEFREE2015-11-13
FENWAL, INC. [Fresenius Kabi AG]
BLOOD SET 170 MICRON FILTER NEEDLEFREE2015-11-13
FENWAL, INC. [Fresenius Kabi AG]
60 IN. MICROBORE, 0.2 MICRON FILTER LPV2015-11-13
FENWAL, INC. [Fresenius Kabi AG]
6 IN. EXTENSION, 0.2 MICRON AE FILTER2015-11-13
FENWAL, INC. [Fresenius Kabi AG]
40 IN. EXTENSION SET, STOPCOCK2015-11-13
FENWAL, INC. [Fresenius Kabi AG]
4-WAY HI-FLOW STOPCOCK2015-11-13
FENWAL, INC. [Fresenius Kabi AG]
3 IN. EXTENSION, 1.2 MICRON AE FILTER2015-11-13
FENWAL, INC. [Fresenius Kabi AG]
3 IN. EXTEN, 1.2 MICRON AE FILTER2015-11-13
FENWAL, INC. [Fresenius Kabi AG]
TRIFURCATED EXTENSION, FLL, PINCH CLAMP2015-11-13
FENWAL, INC. [Fresenius Kabi AG]
70 IN. EXTENSION GREEN STRIPE TUBING, LL2015-11-13
FENWAL, INC. [Fresenius Kabi AG]
60 IN. EXTENSION SET W/ LUER LOCKS2015-11-13
FENWAL, INC. [Fresenius Kabi AG]
288 IN. EXT. SET W/FEMALE/MALE LUER2015-11-13
FENWAL, INC. [Fresenius Kabi AG]
TRIFURCATED EXTENSION, NEEDLEFREE VALVES2015-11-13
FENWAL, INC. [Fresenius Kabi AG]
EXTENSION T-CONNECTOR, NEEDLEFREE VALVE2015-11-13
FENWAL, INC. [Fresenius Kabi AG]
EXTENSION SET, NEEDLEFREE VALVE2015-11-13
FENWAL, INC. [Fresenius Kabi AG]
EXTENSION SET, 2 -NEEDLEFREE VALVES2015-11-13
FENWAL, INC. [Fresenius Kabi AG]
BIFURCATED EXTENSION, NEEDLEFREE VALVE2015-11-13
FENWAL, INC. [Fresenius Kabi AG]
60D VENTED, Y-NEEDLEFREE VALVE2015-11-13
FENWAL, INC. [Fresenius Kabi AG]
60D VENTED, BCV,Y-NEEDLEFREE VALVE2015-11-13
FENWAL, INC. [Fresenius Kabi AG]
60D VENTED, BCV, 3 NEEDLEFREE VALVES2015-11-13
FENWAL, INC. [Fresenius Kabi AG]
60D VENTED, BCV, 2 NEEDLEFREE VALVES2015-11-13
FENWAL, INC. [Fresenius Kabi AG]
60D VENTED, 3 NEEDLEFREE VALVES2015-11-13
FENWAL, INC. [Fresenius Kabi AG]
60D VENTED, 2 NEEDLEFREE VALVES2015-11-13
FENWAL, INC. [Fresenius Kabi AG]
60 IN. EXTENSION SET W/ NEEDLEFREE VALVE2015-11-13
FENWAL, INC. [Fresenius Kabi AG]
6 IN. EXTENSION SET, NEEDLEFREE VALVE2015-11-13
FENWAL, INC. [Fresenius Kabi AG]
4 IN. EXTENSION SET, NEEDLEFREE VALVE2015-11-13
FENWAL, INC. [Fresenius Kabi AG]
20D NON-VENTED, NEEDLEFREE VALVE2015-11-13
FENWAL, INC. [Fresenius Kabi AG]
20D NON-VENTED, INLINE BCV, NEEDLEFREE2015-11-13
FENWAL, INC. [Fresenius Kabi AG]
20D NON-VENTED, BCV, 3 NEEDLEFREE VALVES2015-11-13
FENWAL, INC. [Fresenius Kabi AG]
20D NON-VENTED, BCV, 2 NEEDLEFREE2015-11-13
FENWAL, INC. [Fresenius Kabi AG]
20D NON-VENTED, 3 NEEDLEFREE VALVES2015-11-13
FENWAL, INC. [Fresenius Kabi AG]
20D NON-VENTED, 2 NEEDLEFREE VALVES2015-11-13
FENWAL, INC. [Fresenius Kabi AG]
ALYX Component Collection System2015-05-12
FENWAL, INC. [Fresenius Kabi AG]
ALYX 2RBC LR Kit with Saline Spike2015-05-12
Fenwal Inc
Automated Blood Cell Separators2015-04-22
Fenwal, Inc., Fenwal International, Inc.
Prescription Medication2014-12-03
FENWAL, INC. [Fresenius Kabi AG]
Slide Clamp2014-11-05
FENWAL, INC. [Fresenius Kabi AG]
Sampling Site Coupler2014-11-05
FENWAL, INC. [Fresenius Kabi AG]
Plasma Extractor2014-11-05
FENWAL, INC. [Fresenius Kabi AG]
Hand Sealer2014-11-05
FENWAL, INC. [Fresenius Kabi AG]
Hand Sealer Clip2014-11-05
FENWAL, INC. [Fresenius Kabi AG]
Transfer-Pack2014-10-20
FENWAL, INC. [Fresenius Kabi AG]
Red Blood Cell Freezing Pack2014-10-20
FENWAL, INC. [Fresenius Kabi AG]
DISPOSABLE APHERESIS KIT2014-10-20
FENWAL, INC. [Fresenius Kabi AG]
Y-Type Connector Set2014-10-20
FENWAL, INC. [Fresenius Kabi AG]
PLASMA TRANSFER SET2014-10-20
FENWAL, INC. [Fresenius Kabi AG]
AMICUS SEPARATOR SYSTEM2014-10-17
FENWAL, INC. [Fresenius Kabi AG]
AMICUS SEPARATOR SYSTEM2014-10-17
FENWAL, INC. [Fresenius Kabi AG]
BORA UP OP2014-10-17
FENWAL, INC. [Fresenius Kabi AG]
BORA UP 20802014-10-17
FENWAL, INC. [Fresenius Kabi AG]
BORA UP 2080 MOUNTING2014-10-17
FENWAL, INC. [Fresenius Kabi AG]
AUTOPHERESIS-C INSTRUMENT, MODEL A-200 PLASMAPHERESIS INSTRUMENT2014-10-17
FENWAL, INC. [Fresenius Kabi AG]
ALYX COMPONENT COLLECTION SYSTEM, 4R57072014-10-17
FENWAL, INC. [Fresenius Kabi AG]
ALYX COMPONENT COLLECTION SYSTEM (ALYX CLASSIC)2014-10-17
FENWAL, INC. [Fresenius Kabi AG]
ALYX COMPONENT COLLECTION SYSTEM (ALYX BY FENWAL)2014-10-17
FENWAL, INC. [Fresenius Kabi AG]
ALYX COMPONENT COLLECTION SYSTEM (ALYX BY FENWAL), 4R57252014-10-17
FENWAL, INC. [Fresenius Kabi AG]
PLASMACELL-C DISPOSABLE SET2014-10-17
FENWAL, INC. [Fresenius Kabi AG]
AUTOPHERESIS-C SYSTEM2014-10-17
FENWAL, INC. [Fresenius Kabi AG]
AUTOPHERESIS-C PLASMAPHERESIS SYSTEM2014-10-17
FENWAL, INC. [Fresenius Kabi AG]
AUTO-C SYSTEM2014-10-17
FENWAL, INC. [Fresenius Kabi AG]
AMICUS SEPARATOR SYSTEM2014-10-17
FENWAL, INC. [Fresenius Kabi AG]
AMICUS APHERESIS KITS2014-10-17
FENWAL, INC. [Fresenius Kabi AG]
AMICUS SEPARATOR, MONONUCLEAR CELL COLLECTION2014-10-17
FENWAL, INC. [Fresenius Kabi AG]
DXT RELAY FOR THERAPEUTICS2014-10-17
FENWAL, INC. [Fresenius Kabi AG]
LAB EQUIPMENT2014-10-17
FENWAL, INC. [Fresenius Kabi AG]
NPS ACCESS DEVICE2014-10-17
FENWAL, INC. [Fresenius Kabi AG]
MULTI-SAMPLING CONNECTOR2014-10-17
FENWAL, INC. [Fresenius Kabi AG]
LAB EQUIPMENT2014-10-17
FENWAL, INC. [Fresenius Kabi AG]
CompoSampler2014-10-17
FENWAL, INC. [Fresenius Kabi AG]
FENWAL TISSUE CULTURE FLASK2014-10-17
FENWAL, INC. [Fresenius Kabi AG]
CENTRIFUGE BAG2014-10-17
FENWAL, INC. [Fresenius Kabi AG]
Alyx Cart2014-10-17
FENWAL, INC. [Fresenius Kabi AG]
KIT, IV POLE2014-10-17
FENWAL, INC. [Fresenius Kabi AG]
SEPACELL R-500II LEUKOCYTE REDUCTION ADMINISTRATION SET FOR RED CELL TRANSFUSION2014-10-16
FENWAL, INC. [Fresenius Kabi AG]
SEPACELL LEUKOCYTE REDUCTION FILTER FOR RED CELLS2014-10-16
FENWAL, INC. [Fresenius Kabi AG]
BONE MARROW COLLECTION STAND2014-10-16
FENWAL, INC. [Fresenius Kabi AG]
BONE MARROW COLLECTION KIT2014-10-16
FENWAL, INC. [Fresenius Kabi AG]
AMICUS SEPARATOR SYSTEM2014-10-16
FENWAL, INC. [Fresenius Kabi AG]
AMICUS EXCHANGE KIT2014-10-16
FENWAL, INC. [Fresenius Kabi AG]
PLASTIC STORAGE CONTAINER2014-10-16
FENWAL, INC. [Fresenius Kabi AG]
AMICUS SEPARATOR, COLLECTION OF THREE PLATELET PRODUCTS2014-10-16
FENWAL, INC. [Fresenius Kabi AG]
SEPACELL PRE-STORAGE LEUKOCYTE REDUCTION SETS FOR RED CELLS2014-10-16
FENWAL, INC. [Fresenius Kabi AG]
HEMATYPE SEGMENT DEVICE2014-10-16
FENWAL, INC. [Fresenius Kabi AG]
AMICUS SEPARATOR2014-10-16
FENWAL, INC. [Fresenius Kabi AG]
SEPACELL LEUKOCYTE REDUCTION ADMINISTRATION SETS2014-10-16
FENWAL, INC. [Fresenius Kabi AG]
NEEDLE/TUBE SAMPLING PROTECTOR2014-10-16
FENWAL, INC. [Fresenius Kabi AG]
PLASMA POOLING BOTTLE WITH TRANSFER SET2014-10-16
FENWAL, INC. [Fresenius Kabi AG]
PLASMA POOLING BOTTLE W/TRANSFER SET2014-10-16
FENWAL, INC. [Fresenius Kabi AG]
ALYX PLASMA KIT2014-10-16
FENWAL, INC. [Fresenius Kabi AG]
ALYX COMPONENT COLLECTION SYSTEM (ALYX CLASSIC)2014-10-16
FENWAL, INC. [Fresenius Kabi AG]
ALYX COMPONENT COLLECTION SYSTEM (ALYX BY FENWAL)2014-10-16
FENWAL, INC. [Fresenius Kabi AG]
AMICUS SEPARATOR SYSTEM2014-10-16
FENWAL, INC. [Fresenius Kabi AG]
AMICUS APHERESIS KITS2014-10-16
FENWAL, INC. [Fresenius Kabi AG]
AMICUS SEPARATOR SYSTEM2014-10-16
FENWAL, INC. [Fresenius Kabi AG]
ALYX COMPONENT COLLECTION SYSTEM2014-10-16
FENWAL, INC. [Fresenius Kabi AG]
PLASMACELL-C DISPOSABLE SET2014-10-16
FENWAL, INC. [Fresenius Kabi AG]
AURORA PLASMAPHERESIS SYSTEM2014-10-16
FENWAL, INC. [Fresenius Kabi AG]
PRODUCT SAMPLE PACK2014-10-16
FENWAL, INC. [Fresenius Kabi AG]
AUTOPHERESIS-C SYSTEM2014-10-16
FENWAL, INC. [Fresenius Kabi AG]
AUTOPHERESIS-C PLASMAPHERESIS SYSTEM2014-10-16
FENWAL, INC. [Fresenius Kabi AG]
AUTO-C SYSTEM2014-10-16
FENWAL, INC. [Fresenius Kabi AG]
AMICUS SEPARATOR SYSTEM2014-10-16
FENWAL, INC. [Fresenius Kabi AG]
4R4580R - AMICUS SEPARATOR, REFURBISHED2014-10-16
FENWAL, INC. [Fresenius Kabi AG]
4R4580 - AMICUS SEPARATOR2014-10-16
FENWAL, INC. [Fresenius Kabi AG]
ALYX COMPONENT COLLECTION SYSTEM: ALYX 2RBC-NLR KIT2014-10-16
FENWAL, INC. [Fresenius Kabi AG]
AMICUS SEPARATOR SYSTEM2014-10-16
FENWAL, INC. [Fresenius Kabi AG]
ALYX RBC / Plasma Kit2014-10-16
FENWAL, INC. [Fresenius Kabi AG]
ALYX COMPONENT COLLECTION SYSTEM2014-10-16
FENWAL, INC. [Fresenius Kabi AG]
AMICUS SEPARATOR SYSTEM2014-10-16
FENWAL, INC. [Fresenius Kabi AG]
AMICUS SEPARATOR SYSTEM2014-10-16
FENWAL, INC. [Fresenius Kabi AG]
ALYX Component Collection System2014-10-16
FENWAL, INC. [Fresenius Kabi AG]
ALYX 2 RBC-LR Kit2014-10-16
FENWAL, INC. [Fresenius Kabi AG]
ALYX Component Collection System2014-10-16
FENWAL, INC. [Fresenius Kabi AG]
ALYX Component Collection System2014-10-16
FENWAL, INC. [Fresenius Kabi AG]
ALYX 2RBC DISPOSABLE SET2014-10-16
FENWAL, INC. [Fresenius Kabi AG]
LEUKOCONNECT PRE-STORAGE STERILE CONNECT LEUKOREDUCTION SET W/SEPACELL FILTER FOR RED BLOOD CELLS2014-10-16
FENWAL, INC. [Fresenius Kabi AG]
ALYX INSTRUMENT2014-10-16
FENWAL, INC. [Fresenius Kabi AG]
ALYX Component Collection System2014-10-16
FENWAL, INC. [Fresenius Kabi AG]
ALYX 2RBC-LR Kit2014-10-16
FENWAL, INC. [Fresenius Kabi AG]
ALYX 2RBC DISPOSABLE SET2014-10-16
FENWAL, INC. [Fresenius Kabi AG]
AMICUS SEPARATOR, RED BLOOD CELL CONCURRENT COLLECTION2014-10-16
FENWAL, INC. [Fresenius Kabi AG]
Y-TYPE BLOOD COMPONENT RECIPIENT SET2014-10-15
FENWAL, INC. [Fresenius Kabi AG]
Blood Component Recipient Set2014-10-15
FENWAL, INC. [Fresenius Kabi AG]
Blood Component Infusion Set2014-10-15
FENWAL, INC. [Fresenius Kabi AG]
CS-3000 BLOOD CELL SEPARATOR APHERESIS KIT2014-10-15
FENWAL, INC. [Fresenius Kabi AG]
DXT Relay2014-10-15
FENWAL, INC. [Fresenius Kabi AG]
ALYX COMPONENT COLLECTION SYSTEM2014-10-15
FENWAL, INC. [Fresenius Kabi AG]
AUTOPHERESIS-C PLASMAPHERESIS SYSTEM2014-10-15
FENWAL, INC. [Fresenius Kabi AG]
AMICUS SEPARATOR SYSTEM2014-10-15
FENWAL, INC. [Fresenius Kabi AG]
PLASMACELL-C DISPOSABLE SET2014-10-15
FENWAL, INC. [Fresenius Kabi AG]
AUTOPHERESIS-C SYSTEM2014-10-15
FENWAL, INC. [Fresenius Kabi AG]
AUTOPHERESIS-C PLASMAPHERESIS SYSTEM2014-10-15
FENWAL, INC. [Fresenius Kabi AG]
AUTO-C SYSTEM2014-10-15
FENWAL, INC. [Fresenius Kabi AG]
AMICUS SEPARATOR (4R4580, 4R4580R)2014-10-15
FENWAL, INC. [Fresenius Kabi AG]
AMICUS MNC APHERESIS KIT-DOUBLE NEEDLE2014-10-15
FENWAL, INC. [Fresenius Kabi AG]
AMICUS MNC APHERESIS KIT - DOUBLE NEEDLE2014-10-15
FENWAL, INC. [Fresenius Kabi AG]
AMICUS APHERESIS KIT-SINGLE NEEDLE2014-10-15
FENWAL, INC. [Fresenius Kabi AG]
AMICUS APHERESIS KIT-SINGLE NEEDLE W/PAS CONNECTOR2014-10-15
FENWAL, INC. [Fresenius Kabi AG]
AMICUS APHERESIS KIT-DOUBLE NEEDLE2014-10-15
FENWAL, INC. [Fresenius Kabi AG]
AMICUS APHERESIS KIT-DOUBLE NEEDLE W/PAS CONNECTOR2014-10-15
FENWAL, INC. [Fresenius Kabi AG]
AMICUS APHERESIS KIT - SINGLE NEEDLE2014-10-15
FENWAL, INC. [Fresenius Kabi AG]
AMICUS APHERESIS KIT - SINGLE NEEDLE W/PAS CONNECTOR2014-10-15
FENWAL, INC. [Fresenius Kabi AG]
AMICUS APHERESIS KIT - DOUBLE NEEDLE W/PAS CONNECTOR2014-10-15
FENWAL, INC. [Fresenius Kabi AG]
AMICUS SEPARATOR SYSTEM2014-10-15
FENWAL, INC. [Fresenius Kabi AG]
Fenwal Bone Marrow Collection Kit with Accessories2014-10-15
FENWAL, INC. [Fresenius Kabi AG]
Bone Marrow Collection Kit and Stand2014-10-15
FENWAL, INC. [Fresenius Kabi AG]
BONE MARROW COLLECTION KIT WITH ACCESSORIES2014-10-15
FENWAL, INC. [Fresenius Kabi AG]
BONE MARROW COLLECTION KIT W/ACCESSORIES2014-10-15
FENWAL, INC. [Fresenius Kabi AG]
ALYX COMPONENT COLLECTION SYSTEM2014-10-15
FENWAL, INC. [Fresenius Kabi AG]
AMICUS SEPARATOR SYSTEM2014-10-15
FENWAL, INC. [Fresenius Kabi AG]
PLASMALINK POOLING BOTTLE2014-10-15
FENWAL, INC. [Fresenius Kabi AG]
ALYX COMPONENT COLLECTION SYSTEM (6R5725)2014-10-15
FENWAL, INC. [Fresenius Kabi AG]
ALYX COMPONENT COLLECTION SYSTEM (4R5707, 4R5725)2014-10-15
FENWAL, INC. [Fresenius Kabi AG]
AMICUS SEPARATOR SYSTEM2014-10-15
FENWAL, INC. [Fresenius Kabi AG]
ALYX COMPONENT COLLECTION SYSTEM (4R5707, 4R5725)2014-10-15
FENWAL, INC.
AMICUS SEPARATOR SYSTEM/ AMICUS SEPERATOR SYSTEM;REFURBISHED2014-06-10
Fenwal, Inc., Fenwal International, Inc.
Prescription Medication2014-04-03
Fenwal, Inc., Fenwal International, Inc.
Prescription Medication2014-04-03
Fenwal, Inc.
Prescription Medication2014-04-03
Fenwal, Inc.
Prescription Medication2014-04-03
Fenwal, Inc.
Prescription Medication2014-04-03
Fenwal, Inc., Fenwal International, Inc.
Prescription Medication2014-04-03
Fenwal, Inc.
Prescription Medication2014-04-03
Fenwal, Inc., Fenwal International, Inc.
Prescription Medication2014-04-03
Fenwal, Inc.
Prescription Medication2014-04-03
Fenwal, Inc.
Prescription Medication2014-04-03
Fenwal, Inc., Fenwal International, Inc.
Prescription Medication2014-04-03
Fenwal, Inc.
Prescription Medication2014-04-03
Fenwal, Inc.
Prescription Medication2014-04-03
Fenwal, Inc.
Prescription Medication2014-04-03
Fenwal, Inc.
Prescription Medication2014-04-03
Fenwal, Inc.
Prescription Medication2014-04-03
Fenwal, Inc., Fenwal International, Inc.
Prescription Medication2014-04-03
Fenwal, Inc., Fenwal International, Inc.
Prescription Medication2014-04-03
Fenwal, Inc.
Prescription Medication2014-04-03
Fenwal, Inc., Fenwal International
Prescription Medication2014-04-03
Fenwal, Inc., Fenwal International, Inc.
Prescription Medication2014-04-03
Fenwal, Inc.
Prescription Medication2014-04-03
Fenwal, Inc., Fenwal International, Inc.
Prescription Medication2014-04-03
Fenwal, Inc.
Prescription Medication2014-04-03
Fenwal, Inc., Fenwal International, Inc.
Prescription Medication2014-04-03
Fenwal, Inc., Fenwal International, Inc.
Prescription Medication2014-04-03
Fenwal, Inc., Fenwal International, Inc.
Prescription Medication2014-04-03
Fenwal, Inc.
Prescription Medication2014-04-03
Fenwal, Inc.
Automated Blood Cell Separators2013-11-01
Fenwal Inc
Automated Blood Cell Separators2013-09-11
FENWAL, INC. [Fresenius Kabi AG]
VOLUMAT MC AGILIA2013-05-23
FENWAL, INC. [Fresenius Kabi AG]
VOLUMAT LINES2013-05-23
FENWAL, INC. [Fresenius Kabi AG]
COMPOMAT G5 AND COMPOMASTER NET G5 SYSTEM2013-04-10
Fenwal, Inc.
CPD/ADSOL2013-02-13
Fenwal Inc
Automated Blood Cell Separators2013-01-08
Fenwal, Inc.
Automated Blood Cell Separators2012-12-18
Fenwal, Inc.
CPDA-12012-12-04
Fenwal, Inc.
Solucion InterSol2012-10-25
Fenwal, Inc.
InterSol2012-10-25
Fenwal Inc.
ACD-A2012-10-24
Fenwal, Inc.
Automated Blood Cell Separators2012-10-03
Fenwal, Inc.
Automated Blood Cell Separators2012-07-20
Fenwal Inc
Automated Blood Cell Separators2012-03-29
FENWAL, INC.
AMICUS SEPARATOR SYSTEM- USE IN THERAPEUTIC PLASMA EXCHANGE AND FILTER SET FOR AMICUS TPE2012-03-22
Fenwal Inc
Empty Containers For The Collection & Processing Of Blood/Blood Components2012-02-27
Fenwal Inc
Automated Blood Cell Separators2011-12-23
Fenwal Inc
510(k) Premarket Notification // Quick Links: Skip To Main Page Content Skip To Search Skip To Topics Menu Skip To Common Links U.S. Food & Drug Administration   Follow FDA En Español Search FDA   Home Food Drugs Medical Devices 2011-08-22
FENWAL, INC. [Fresenius Kabi AG]
ATY-Y ADAPTER2011-04-29
FENWAL, INC. [Fresenius Kabi AG]
ATS SUCTION LINE2011-04-29
FENWAL, INC. [Fresenius Kabi AG]
ATO OXYGENATOR LINE2011-04-29
FENWAL, INC. [Fresenius Kabi AG]
PSQ-DD PLASMA SEQUESTRATION2011-04-29
FENWAL, INC. [Fresenius Kabi AG]
PSQ PLASMA SEQUESTRATION SET2011-04-29
FENWAL, INC. [Fresenius Kabi AG]
C4L PLATELET SET2011-04-29
FENWAL, INC. [Fresenius Kabi AG]
C4 PLATELET SET2011-04-29
Fenwal, Inc.
ADSOL Red Cell Preservation Solution System In Plastic Container (PL 146 Plastic)2011-03-04
Fenwal, Inc.
ADSOL Red Cell Preservation Solution System In Plastic Container (PL 146 Plastic)2011-01-11
Fenwal Inc
Automated Blood Cell Separators2010-12-07
FENWAL, INC. [Fresenius Kabi AG]
HEMOFREEZE BAGS2010-11-25
Fenwal Inc
Automated Blood Cell Separators2010-11-16
Fenwal, Inc.
ADSOL Red Cell Preservation Solution System In Plastic Container (PL 146 Plastic)2010-09-28
Fenwal, Inc.
CPDA-12010-08-19
Fenwal, Inc.
Automated Blood Cell Separators2010-07-30
Fenwal, Inc.
ADSOL Red Cell Preservation Solution System In Plastic Container (PL 146 Plastic)2010-06-21
Fenwal, Inc.
CPDA-12010-06-21
Fenwal, Inc.
CPDA-12010-06-21
Fenwal, Inc.
ADSOL Red Cell Preservation Solution System In Plastic Container (PL 146 Plastic)2010-05-25
Fenwal, Inc.
ADSOL Red Cell Preservation Solution System In Plastic Container (PL 146 Plastic)2010-05-25
Fenwal, Inc.
CPDA-12010-05-25
Fenwal, Inc.
CPDA-12010-05-25
Fenwal, Inc.
CPDA-12010-05-25
Fenwal, Inc.
CPDA-12010-05-25
Fenwal, Inc.
CPDA-12010-05-17
Fenwal Inc
Automated Blood Cell Separators2010-03-04
Fenwal Inc
Automated Blood Cell Separators2010-02-18
Fenwal Inc
Kit, Bone Marrow Collection2009-07-23
Fenwal, Inc.
ADSOL Red Cell Preservation Solution System In Plastic Container (PL 146 Plastic)2009-05-15
Fenwal, Inc.
ADSOL Red Cell Preservation Solution System In Plastic Container (PL 146 Plastic)2009-05-15
Fenwal Inc
Automated Blood Cell Separators2008-12-22
Fenwal, Inc.
CPDA-12008-12-15
Fenwal Inc
Automated Blood Cell Separators2008-10-02
Fenwal, Inc.
Automated Blood Cell Separators2008-08-26
Fenwal, Inc.
Empty Containers For The Collection & Processing Of Blood/Blood Components2008-08-22
Fenwal Inc
Automated Blood Cell Separators2008-06-24
FENWAL, INC.
BLOOD COMPONENT RECIPIENT SET WITH STANDARD SIZE FILTER AND INFUSION SET WITH SIDE ARM LUER CONNECTOR2008-03-03
Fenwal, Inc.
ADSOL Red Cell Preservation Solution System In Plastic Container (PL 146 Plastic)2008-02-10
Fenwal, Inc.
CPD/ADSOL Red Cell Preservation Solution System (PL 2209)2008-02-01
Fenwal, Inc.
CPD/ADSOL Red Cell Preservation Solution System (PL 2209)2008-01-31
Fenwal, Inc.
CPD/ADSOL Red Cell Preservation Solution System (PL 2209)2008-01-31
FENWAL, INC. [Fresenius Kabi AG]
TAKY-SPIKE PLUS2008-01-08
FENWAL, INC. [Fresenius Kabi AG]
COMPOCOOL2007-11-29
FENWAL, INC. [Fresenius Kabi AG]
COMPODOCK2007-11-16
FENWAL, INC. [Fresenius Kabi AG]
HEMOLIGHT PLUS2007-11-16
FENWAL, INC. [Fresenius Kabi AG]
DONATION MASTER NT2007-11-16
FENWAL, INC. [Fresenius Kabi AG]
COMPOGUARD2007-11-16
FENWAL, INC. [Fresenius Kabi AG]
COMPOMAT G42007-11-16
FENWAL, INC. [Fresenius Kabi AG]
COMPOMASTER NT2007-11-16
FENWAL, INC. [Fresenius Kabi AG]
P1R PLASMA TREATMENT SET2007-10-26
FENWAL, INC. [Fresenius Kabi AG]
AS1042007-10-26
FENWAL, INC. [Fresenius Kabi AG]
Waste bag 10 L2007-10-19
FENWAL, INC. [Fresenius Kabi AG]
Reinfusion Bag with Y-Adapter2007-10-19
FENWAL, INC. [Fresenius Kabi AG]
Reinfusion Bag 1000 mL2007-10-19
FENWAL, INC. [Fresenius Kabi AG]
Fresenius CATS Autotransfusion Syst2007-10-19
FENWAL, INC. [Fresenius Kabi AG]
ATF 40 Fast Start Kit2007-10-19
FENWAL, INC. [Fresenius Kabi AG]
ATF 120 Fast Start Kit2007-10-19
FENWAL, INC. [Fresenius Kabi AG]
AT1 Autotransfusion Set2007-10-19
FENWAL, INC. [Fresenius Kabi AG]
TPE Plasma Exchange Set2007-10-19
FENWAL, INC. [Fresenius Kabi AG]
COM.TEC CELL SEPARATOR2007-10-19
Fenwal, Inc.
ADSOL Red Cell Preservation Solution System In Plastic Container (PL 146 Plastic)2007-10-01
Fenwal, Inc.
CPD/ADSOL2007-10-01
Fenwal, Inc.
CPDA-12007-06-24
Fenwal, Inc.
CPDA-12007-06-20
Fenwal, Inc.
ADSOL Red Cell Preservation Solution System In Plastic Container (PL 146 Plastic)2007-06-11
Fenwal, Inc.
ADSOL Red Cell Preservation Solution System In Plastic Container (PL 146 Plastic)2007-06-06
Fenwal, Inc.
ADSOL Red Cell Preservation Solution System In Plastic Container (PL 146 Plastic)2007-06-06
Fenwal, Inc.
ADSOL Red Cell Preservation Solution System In Plastic Container (PL 146 Plastic)2007-06-06
Fenwal, Inc.
ADSOL Red Cell Preservation Solution System In Plastic Container (PL 146 Plastic)2007-06-04
Fenwal, Inc.
ADSOL Red Cell Preservation Solution System In Plastic Container (PL 146 Plastic)2007-06-04
Fenwal, Inc.
CPDA-12007-06-04
Fenwal, Inc.
CPDA-12007-06-01
Fenwal, Inc.
ADSOL Red Cell Preservation Solution System In Plastic Container (PL 146 Plastic)2007-05-01
Fenwal, Inc.
Anticoagulant Citrate Phosphate Dextrose (CPD) Blood-Pack Units In PL 146 Plastic2007-03-31
Fenwal, Inc.
Sodium Citrate Blood-Pack Units, (PL 146 Plastic)2007-03-01
Fenwal, Inc.
Sodium Citrate Blood-Pack Units, (PL 146 Plastic)2007-03-01
Fenwal, Inc.
Sodium Citrate Blood-Pack Units, (PL 146 Plastic)2007-03-01
Fenwal, Inc.
CPDA-12007-03-01
Fenwal, Inc.
CPDA-12007-03-01
Fenwal, Inc.
CPDA-12007-03-01
Fenwal, Inc.
CPDA-12007-03-01
Fenwal, Inc.
CPDA-12007-03-01
Fenwal, Inc.
CPD2007-03-01
Fenwal, Inc.
Anticoagulant Citrate Phosphate Dextrose (CPD) Blood-Pack Units In PL 146 Plastic2007-03-01
Fenwal, Inc.
ACD Blood-Pack Units (PL 146 Plastic)2007-03-01
Fenwal, Inc.
ADSOL Red Cell Preservation Solution System In Plastic Container (PL 146 Plastic)2007-03-01
Fenwal, Inc.
ADSOL Red Cell Preservation Solution System In Plastic Container (PL 146 Plastic)2007-03-01
Fenwal, Inc.
ADSOL Red Cell Preservation Solution System In Plastic Container (PL 146 Plastic)2007-03-01
Fenwal, Inc.
ADSOL Red Cell Preservation Solution System In Plastic Container (PL 146 Plastic)2007-03-01
Fenwal, Inc.
ADSOL Red Cell Preservation Solution System In Plastic Container (PL 146 Plastic)2007-03-01
Fenwal, Inc.
ADSOL Red Cell Preservation Solution System In Plastic Container (PL 146 Plastic)2007-03-01
Fenwal, Inc.
ADSOL Red Cell Preservation Solution System In Plastic Container (PL 146 Plastic)2007-03-01
Fenwal, Inc.
ADSOL Red Cell Preservation Solution System In Plastic Container (PL 146 Plastic)2007-03-01
Fenwal, Inc.
ADSOL Red Cell Preservation Solution System In Plastic Container (PL 146 Plastic)2007-03-01
Fenwal, Inc.
ADSOL Red Cell Preservation Solution System In Plastic Container (PL 146 Plastic)2007-03-01
Fenwal, Inc.
ADSOL Red Cell Preservation Solution System In Plastic Container (PL 146 Plastic)2007-03-01
Fenwal, Inc.
ADSOL Red Cell Preservation Solution System In Plastic Container (PL 146 Plastic)2007-03-01
Fenwal, Inc.
ADSOL Red Cell Preservation Solution System In Plastic Container (PL 146 Plastic)2007-03-01
Fenwal, Inc.
ADSOL Red Cell Preservation Solution System In Plastic Container (PL 146 Plastic)2007-03-01
Fenwal, Inc.
ADSOL Red Cell Preservation Solution System In Plastic Container (PL 146 Plastic)2007-03-01
Fenwal, Inc.
ADSOL Red Cell Preservation Solution System In Plastic Container (PL 146 Plastic)2007-03-01
Fenwal, Inc.
ADSOL Red Cell Preservation Solution System In Plastic Container (PL 146 Plastic)2007-03-01
Fenwal, Inc.
CPDA-12007-03-01
Fenwal, Inc.
CPDA-12007-03-01
Fenwal, Inc.
CPDA-12007-03-01
Fenwal, Inc.
CPDA-12007-03-01
Fenwal, Inc.
CPDA-12007-03-01
Fenwal, Inc.
CPDA-12007-03-01
Fenwal, Inc.
CPDA-12007-03-01
Fenwal, Inc.
CPDA-12007-03-01
Fenwal Inc
ACD-A2007-03-01
Fenwal Inc
Automated Blood Cell Separators2007-02-09
Fenwal Inc
Automated Blood Cell Separators2005-11-03
FENWAL, INC. [Fresenius Kabi AG]
FRESENIUS CATS AUT2005-09-14
FENWAL, INC. [Fresenius Kabi AG]
ATR402005-09-14
FENWAL, INC. [Fresenius Kabi AG]
ATR1202005-09-14
FENWAL, INC. [Fresenius Kabi AG]
ATR Cap Set2005-09-14
FENWAL, INC. [Fresenius Kabi AG]
FRESENIUS CELL SEPARATION SYSTEM2005-09-14
FENWAL, INC. [Fresenius Kabi AG]
FRESENIUS CATS AUT2005-09-14
Fenwal Inc
Automated Blood Cell Separators2005-03-15
Fenwal Inc
Automated Blood Cell Separators2004-09-24
Fenwal Inc
Automated Blood Cell Separators2004-03-15
FENWAL, INC. [Fresenius Kabi AG]
HEMOCONCENTRATOR2003-09-26
Fenwal Inc
Automated Blood Cell Separators2002-12-20
Fenwal Inc
510(k) Premarket Notification // Quick Links: Skip To Main Page Content Skip To Search Skip To Topics Menu Skip To Common Links U.S. Food & Drug Administration   Follow FDA En Español Search FDA   Home Food Drugs Medical Devices 2002-12-10
Fenwal Inc
Automated Blood Cell Separator -Filtration2002-08-27
Fenwal Inc
Automated Blood Cell Separator -Filtration2002-08-26
Fenwal Inc
Automated Blood Cell Separator -Filtration2002-07-31
Fenwal Inc
Automated Blood Cell Separators2000-03-03
Fenwal Inc
Blood Transfusion Microfilters1999-07-16
FENWAL, INC. [Fresenius Kabi AG]
FRESENIUS KABI DONOR TUBE STRIPPER1999-06-01
FENWAL, INC. [Fresenius Kabi AG]
HEAT SEALER1999-06-01
FENWAL, INC. [Fresenius Kabi AG]
CompoSeal Slim1999-06-01
Fenwal Inc
Blood Bank Supplies1997-02-28
Fenwal Inc
Automated Blood Cell Separators1996-12-19
Fenwal Inc
Empty Containers For The Collection & Processing Of Blood/Blood Components1995-09-20
Fenwal Inc
Automated Blood Cell Separators1995-06-29
Fenwal Inc
Blood Transfusion Microfilters1995-02-28
Fenwal Inc
Empty Containers For The Collection & Processing Of Blood/Blood Components1995-02-14
Fenwal Inc
Empty Containers For The Collection & Processing Of Blood/Blood Components1994-12-27
Fenwal Inc
Empty Containers For The Collection & Processing Of Blood/Blood Components1994-07-27
Fenwal Inc
Empty Containers For The Collection & Processing Of Blood/Blood Components1994-07-27
Fenwal Inc
Blood Bank Supplies1994-07-05
Fenwal Inc
Automated Blood Cell Separators1994-06-20
Fenwal Inc
Blood Bank Supplies1994-05-18
Fenwal Inc
Empty Containers For The Collection & Processing Of Blood/Blood Components1994-05-18
Fenwal Inc
Automated Blood Cell Separators1994-05-06
Fenwal, Inc.
Automated Bloodborne Pathogen Test Equipment1993-07-30
Fenwal Inc
Transfer Sets1993-06-07
Fenwal Inc
510(k) Premarket Notification // Quick Links: Skip To Main Page Content Skip To Search Skip To Topics Menu Skip To Common Links U.S. Food & Drug Administration   Follow FDA En Español Search FDA   Home Food Drugs Medical Devices 1993-06-03
Fenwal Inc
Blood Bank Supplies1992-03-12
Fenwal Inc
Transfer Sets1991-09-18
Fenwal Inc
Empty Containers For The Collection & Processing Of Blood/Blood Components1991-06-07
Fenwal Inc
Automated Blood Cell Separators1990-11-07
Fenwal Inc
Automated Blood Cell Separator -Filtration1990-06-05
Fenwal Inc
Automated Blood Cell Separator -Filtration1989-06-13
Fenwal Inc
Empty Containers For The Collection & Processing Of Blood/Blood Components1988-08-23
Fenwal Inc
Blood Bank Centrifuges For In Vitro Diagnostic Use1987-11-16
FENWAL, INC.
 PLASMA SEPARATION SYSTEM1987-08-25
Fenwal Inc
Automated Blood Cell Separator -Filtration1987-02-26
Fenwal Inc
Automated Blood Cell Separator -Filtration1986-11-28
Fenwal Inc
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Related Finance Registrations
NCAGE Code0L917FENWAL INC
NCAGE Code1V751FENWAL INC
NCAGE Code3K401FENWAL INC
NCAGE Code4Q7Q2FENWAL, INC.
CAGE Code0L917FENWAL INC
CAGE Code4Q7Q2FENWAL, INC.
CAGE Code1V751FENWAL INC
CAGE Code3K401FENWAL INC
S.A.M. Registration4Q7Q2 [794519020]FENWAL, INC.
U.S. Import Records [external site]
Import IDShipmentCargo DescriptionQuantity
20200929104368Rio Jaina,Dominican Republic -> Miami, FloridaBLOOD TRANSFUSION DEVICES24 SKD
20200929104135Rio Jaina,Dominican Republic -> Miami, FloridaBLOOD TRANFUSION DEVICE24 SKD
20200929103752Rio Jaina,Dominican Republic -> Miami, FloridaBLOOD TRANSFUSION DEVICES24 SKD
20200929103960Rio Jaina,Dominican Republic -> Miami, FloridaBLOOD TRANFUSION DEVICE24 SKD
20200929104365Rio Jaina,Dominican Republic -> Miami, FloridaBLOOD TRANSFUSION DEVICES48 SKD
20200929104365Rio Jaina,Dominican Republic -> Miami, FloridaBLOOD TRANSFUSION DEVICES48 SKD
20200929104136Rio Jaina,Dominican Republic -> Miami, FloridaBLOOD TRANFUSION DEVICE24 SKD
20200929103735Rio Jaina,Dominican Republic -> Miami, FloridaBLOOD TRANSFUSION DEVICES24 SKD
20200929103733Rio Jaina,Dominican Republic -> Miami, FloridaBLOOD TRANSFUSION DEVICES24 SKD
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