FDA.reportPublic FDA data

An

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
ANCLOTE MANUFACTURING COMPANY5N2026-01-0112580 Enterprise Blvd Ste A Largo FL US 33773
Angelo Landriscina5N2026-01-011519 Decatur St Ridgewood NY US 11385
ANEUVO5N2026-01-0110940 Wilshire Blvd Ste 2030 Los Angeles CA US 90024
10375771037577ANGIOSYSTEMS, INC.1N2026-01-017 HOPKINS PL. DUCKTOWN TN US 37326
10555811000113231ANODYNE THERAPY, LLC1N2026-01-01301B Mears Blvd Oldsmar FL US 34677
10648583008397795ANDERSEN SCIENTIFIC, INC.1N2026-01-011001 Aviation Parkway Suite 600 Morrisville NC US 27560
12100831210083ANALYTICHEM USA, INC.1N2026-01-01227 China Road Winslow ME US 04901
12207991220799ANDOVER HEALTHCARE, INC.1N2026-01-019 Fanaras Dr SALISBURY MA US 01952
13192111319211ANGIODYNAMICS, INC.1Y2026-01-01603 QUEENSBURY AVE. Queensbury NY US 12804
14168911416891ANCHOR PRODUCTS CO.1N2026-01-0152 OFFICIAL RD. ADDISON IL US 60101
14173671421377AndersonBrecon Inc.1Y2026-01-014545 Assembly Dr ROCKFORD IL US 61109
14508191450819ANDERSONBRECON INC.1N2026-01-011129 18th Ave ROCKFORD IL US 61104
15300871000515530ANATOMICAL CONCEPTS, INC.1N2026-01-011399 E Western Reserve Rd POLAND OH US 44514
18240371824037ANTHONY PRODUCTS, INC.1Y2026-01-017740 RECORDS ST Indianapolis IN US 46226
18257401825740Analytical Control Systems1N2026-01-019058 Technology Drive Fishers IN US 46038
18313381831338ANATECH division of Cancer Diagnostics, Inc.1N2026-01-011020 HARTS LAKE RD. Battle Creek MI US 49037
19297561929756ANODYNE SURGICAL1Y2026-01-01804 Corporate Centre Dr O Fallon MO US 63368
20226482022648Anesthesia Associates, Inc.1Y2026-01-01460 Enterprise Street SAN MARCOS CA US 92078
20273442027344ANDWIN SCIENTIFIC1Y2026-01-01167 W. Cochran St. Simi Valley CA US 93065
20321343003098875ANALYTICAL INDUSTRIES, INC.1N2026-01-012855 METROPOLITAN PL. POMONA CA US 91767
21828612182861ANTARES PHARMA, INC.1N2026-01-0112500 Whitewater Drive Minnetonka MN US 55343
21838732183873ANNEX MEDICAL, INC.1N2026-01-016018 BLUE CIRCLE DR. Minnetonka MN US 55343
22479921000208827Anholt Technologies Inc.1Y2026-01-01440 CHURCH ROAD Avondale PA US 19311
29145372914537ANTIBODIES INCORPORATED1N2026-01-0125242 COUNTY ROAD 95 DAVIS CA US 95616
29169322916932ANAEROBE SYSTEMS1N2026-01-0115906 CONCORD CIRCLE MORGAN HILL CA US 95037

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
756171483233103K991294MODIFICATION TO MEDI-JECT CORPORATION MEDI-JECTOR CHOICE NEEDLE-FREE INSULIN DELIVERY SYSTEMKZE1999-04-23
52111556030078K983428SAFETEX CERVICAL SCRAPER (PLASTIC)HHT1998-11-16
3104051612559066K982624MOLDCARE HEAD & NECK CUSHION, MODEL # MT-ACL-14242IYE1998-10-26
3104051137027588K974703CARBON FIBER BREAST BOARDIYE1998-03-10
528211292653023K974640COAXIAL DILATOR SETDRE1998-03-13
3104051928956041K973842CARBON FIBER CONFORMAL COUCH TOPIXQ1997-12-05
528211608007589K963574PULSE*SPRAY INJECTORFRN1997-07-18
528211121660450K962354DIOMED 15, 30, 60 SURGICAL DIODE LASERGEX1996-09-11
528211840425327K961763PULSE*SPRAY INFUSION SYSTEMQEY1996-07-17
528211756208575K961088NON-CORING NEEDLEFMI1996-07-02
342451036469640K954438SUNMED'S GREENLINE FIBER OPTIC LARYNGOSCOPECCW1995-12-29
528211145939403K954423ANGIOPTIC ANGIOGRAPHIC CATHETERDQO1995-12-01
528211643396741K953529STRATO/INFUSAID LIFE & INFUSE-A-PORT IMPLANTABLE PORT SYSTEMLJT1996-01-26
510591555441193K952736PERCENT OXYGEN SENSORCCL1995-10-18
528211643648818K951814TRIUMPH-1 PORTLJT1995-08-29
3104052012600127K951808MED-TEC REDI-FOAMIYE1995-07-06
528211991069374K951602PULSE*SPRAY INFUSION SYSTEMKRA1995-06-14
528211987580977K951509PULSE*SPRAY INFUSION SYSTEMQEY1995-06-16
528211428074352K950907PULSE*SPRAY INFUSION SYSTEMQEY1995-05-17
3104051687143849K950866HIP FIXATION SYSTEMIYE1995-05-30
768801334974898K941115ACS CARDIO-TROL CONTROLJJY1994-07-20
768802008973395K940397ACS O DILVENT PROTEIN DILUTION MATRIXJJY1994-03-11
768801136146103K940272ACS NORMAL ANGIOTENSIN CONVERTING ENZYME CONTROLJJX1994-04-20
3104051251358885K935411MED-TEC, INC. BREAST BOARD, MT-250IYE1994-07-18
3104051474504761K935300VAC-LOK IMMOBILIZATION SYSTEMIYE1994-07-18
3104051599675673K935067AQUAPLASTIYE1994-05-26
3104051228369369K933227UNI-FRAME HEAD IMMOBILIZATION SYSTEMIYE1994-07-18
132501798268509K931261SPECTROPAD SYSTEMILY1994-03-31
52111769080062K930955CERVEX-BRUSHHHT1994-05-24
768801815589506K930477ACS ANGIOTENSIN CONVERTING ENZYME (ACE) CALIBRATORJIS1993-06-07
768801832831495K925340COAGULATION CONTROL CONTAINING HEMOGLOBINJPA1993-03-23
52111933887955K924908CELL COLLECTING BRUSHHHT1993-04-13
342451358508773K921926JET VENTILATOR/JETTING DEVICEBTL1992-10-13
528211996830883K921674LIFEPORT INFUSION SET AND INFUSION SET W/ Y SITEFPA1992-09-23
768801433067809K921118ACS APCT REAGENTGFO1992-07-28
528211741971847K915273LIFEPORT ATTACHABLE SYSTEM W/INDUCER KIT LPS 5555LJT1993-07-07
528211007242226K914987HIGH PRESSURE CONNECTING SETS, MODIFICATIONDTL1992-05-20
528211284582646K914986GUIDE WIRES, MODIFICATIONDQX1992-05-20
342451834976540K912723POSEY CUFFLATORBSK1991-07-20
528211816614644K911355LIFEPORT VASCU ACCESS SYST/PORT INTRO KIT 7015LJT1991-04-15
528211792411223K905852STRATO PLAST PORT INTRO KT(10 FR)LPS 7013/MODIFIEDLJT1991-04-19
528211336488487K905850STRATO PLASTIC PORT INTRO(9 FR)LPS 7513/MODIFIEDLJT1991-04-19
528211615172106K905849STRATO PLASTIC PORT INTRO KT(10 FR) LPS 7523/MODIFLJT1991-04-19
528211345606957K905845STRATO PORT INTRODUCER KT(9 FR) LPS 5513/MODIFIEDLJT1991-04-19
528211220095825K905839STRATO PORT INTRODUCER KT(10 FR) LPS 5013/MODIFIEDLJT1991-04-19
4271552390347K905462PROCEDURE TRAY/FOR VARIOUS OPHTHALMIC PROCEDURESLRP1991-02-06
528211127669765K905447E-Z-EM PULSED INFUSION SYSTEMKRA1991-04-01
768801763373248K904767ACS CHOLESTREROL/TRIGLYCERIDE LIQUID LINEAR CALIBRJIX1990-12-26
342451912852472K903674MODEL 295 ELECTRONIC RESPIROMETERBZK1991-01-04
768802032878634K902458ACS 0.02 M CALCIUM CHLORIDEJPA1990-08-01
768801166031044K902457ABNORMAL GLYCOHEMOGLOBIN CONTROLLCP1990-07-24
768801460959519K902455ACS NORMAL GLYCOHEMOGLOBIN CONTROL (A1C HGB)LCP1990-07-24
768801973516939K894338ACS ANIMAL PLASMA COAGULATION CONTROL LEVEL IIIGGC1989-07-25
768801492120606K893971ACS ANIMAL PLASMA COAGULATION CONTROL LEVEL IIGGC1989-07-25
768801525273967K893783ACS ANIMAL PLASMA COAGULATION CONTROL LEVEL IGIZ1989-06-23
768801854735860K892213ACS COLLOID OSMOTIC PRESSURE CALIBRATORJIW1989-06-21
360221386900472K890328ADULT RESECTOSCOPEHIH1990-02-06
52111296324152K890283CYTEX ONE AND CYTEX TWOHHT1989-03-16
528211555007829K890208HIGH PRESSURE CONNECTING SETSDXT1989-05-19
528211776155778K890207INTERVENTIONAL PRODUCTS - GUIDE WIRESDQX1989-05-31
4271585186010K864688ARNOLD-KING PRESSURE DRESSINGNAD1987-01-12
768801586527678K863980U.S. DIAGNOSTICS ALKALINE PHOSPHATASE TESTCJE1986-12-04
342451026393481K851265PEAK FLOWMETERS FOR SPIROMETRYBZH1985-10-29
4271876755850K843260ANGIOSYS FEMORAL ANGIOGRAPHY DRAPEKKX1984-09-21
3457301299634269K834357ANA TRANS TUBE & SWABS STERILE PACKJSL1984-01-31
342452034132799K833871UNIVERSAL CONTROL ARMCAI1983-12-27
80262065802977K812314CRITHIDNA ANTI-DNA TEST KITDHN1981-09-01
342451357773660K811614NERVE STIMULATOR MODEL AA 1050BXN1981-06-18
768801018538090K802569ABNORMAL HEMOGLOBIN CONTROLKHG1980-11-12
768801242030208K802568HEMOGLOBIN CONTROLKHG1980-11-12
768801803861598K800559SERTROL PRODUCT # ACS ST 101JJY1980-03-25
768801983587343K800558LIPID CONTROL PRODUCT # ACS LC 101JJY1980-03-25
768801975833616K800370CK/LD ISOENZYME CONTROL PROD. #ACS CT101JJY1980-03-12
311271561074131K790405ANCHOR BRAND COUNT-TAINERMMK1979-03-26
528211748172357K253198NanoKnife Generator (H78720300351US0)OAB2026-03-24
528211672890408K253106AngioVac CannulaDWF2025-10-24
3504391553009590K252893ExaStim® Stimulation System (EXA-001); ExaStim® Stimulation System (EXA-011); ReCure® Electrode Pad (PAD-003); ReCure® Electrode Pad (PAD-013)SDO2026-03-27
528212068794048K252509AlphaVac Multipurpose Mechanical Aspiration System F1885QEZ2025-11-24
528211508404579K240397AlphaVac MMA F1885 System (H787253020)QEZ2024-04-01
528211941624225K231945VenaCure EVLT NeverTouch Procedure Kits; VenaCure EVLT NeverTouch Direct Procedure KitsGEX2023-07-20
3104051726366679K230312Iris AirShuttle™IYE2023-03-31
528212056017681K213388AlphaVac Multipurpose Mechanical Aspiration (MMA) F1885 SystemQEZ2022-04-04
528211277345151K212386AngioVac F18 85DWF2021-09-30
528211067272806K211081AlphaVac Multipurpose Mechanical Aspiration (MMA) SystemQEZ2021-06-04
3104051386694145K211001C-Qual M™ Breastboard; Monarch™ Overhead Arm PositionerIYE2021-05-20
528211694995372K202347UNIFUSE Infusion System with Cooper WireQEY2020-09-15
3104051458988108K193243Alta Multipurpose DeviceIYE2020-02-28
528211812249394K192864UNI*FUSE Infusion System with Cooper WireQEY2020-06-01
528211668054152K190594AngioVac C20, AngioVac C180DWF2019-07-05
528211496346144K190559SmartPort+ Implantable Ports, SmartPort Plastic Implantable PortsLJT2020-05-22
528211125378052K183385NanoKnife SystemOAB2019-06-18
3104051980957754K182189Encompass SRS Headframe ; Encompass MR SRS HeadframeIYE2018-10-04
3104051193948269K182079Solstice SRS Immobilization System; Solstat Immobilization System; Solstice Thermoplastic MaskIYE2018-09-07
528211473982957K181044400um Perforator and Accessory Vein Ablation KitGEX2018-07-05
3104051050311580K180021Proton Positioing and Immobilization DevicesIYE2018-06-29
528211834706153K173762AngioDynamics, Inc. Soft-Vu and Mariner Angiographic CathetersDQO2018-07-18
528211938892550K171921VenaCure EVLT NeverTouch Procedure KitGEX2017-08-24
3104051386979093K171133Qfix® Abdominal/Thoracic Motion Control System,Qfix® SBRT Solution and AccessoriesIYE2017-07-11
528211787903868K170775Mini Stick ENVI Non-Vascular Introducer KitDYB2017-07-19
528211053610738K170743AngioDynamics Total Abscession Biliary Drainage CatheterFGE2017-03-30
528211384999025K170695VenaCure EVLT NeverTouch Direct Introducer SheathDYB2017-05-30
528211626631838K170258SpeedLyser Infusion Catheter KitQEY2017-02-21
528211530146458K163356Pulse* Spray Infusion System, Uni*Fuse Infusion SystemQEY2017-05-30
528211210385945K162914VenaCure EVLT NeverTouch Procedure KitGEX2016-11-16
528211507968503K161596Soft-Vu, Mariner, Accu-Vu and AngioOptic CathetersDQO2017-04-28
336881514754602K160710Oasis Lacrimal Intubation SetOKS2016-05-13
3104051660412942K160627Symphony Patient Transport System, Symphony Patient Trolley, Symphony Standard Transfer Surface, Symphony Portrait (Head/Neck) Transfer Surface, Symphony Brachytherapy solutionIYE2016-06-14
3104051093112439K153270TruGuard Custom Tongue and Jaw PositionerIYE2016-03-08
528211320097432K153228NMI Port, NMI Port IILJT2015-12-04
3104051936050925K153026Body Pro-Lok Respiratory Plate, Respiratory Plate Cushion, Body Pro-Respiratory Belt, Rail Clamp for Respiratory Belt, Pressure Gauge ReplacementIYE2016-05-25
3104051533617155K152321kVue Encompass SRS Insert (Encompass Insert), Encompass SRS Standalone (Encompass Device), Encompass SRS MRI Immobilization device (Encompass MRI Device, Encompass Intracranial Fibreplast Variable Perf Head Only Open View System, Encompass Intracranial Fibreplast Variable Perf Head Only Open View with 119 mm openingIYE2015-12-04
528211581915686K152069Exodus Array Multipurpose Drainage Catheter, Exodus Nuance Nephrostomy Drainage Catheter, Exodus Believe Biliary Drainage CatheterFGE2015-09-24
528211447321313K151724AngioDynamics Mariner Angiographic CathetersDQO2015-10-14
528211837984165K151239NMI DUAL PORT IILJT2016-06-06
528211223496046K150089NanoKnife SystemOAB2015-06-18

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
IYE262023-03-31
GEX212023-07-20
LJT212020-05-22
QEY82020-09-15
OAB72026-03-24
DQO62018-07-18
LJS62010-03-25
JJY51994-07-20
QEZ42025-11-24
DWF42025-10-24
JAI42013-09-26
MSD42011-06-10
HHT41998-11-16
KHG41980-11-12
DYB32017-07-19
FGE32017-03-30
LNH32012-06-08
CCL32006-04-05
DRE22013-09-27
GEI22008-07-03
DQY22006-10-06
FPA22002-03-29
KRA21995-06-14
JJX21994-04-20
JIS21993-06-07
JPA21993-03-23
DQX21992-05-20
LCP21990-07-24
GGC21989-07-25
SDO12026-03-27
OKS12016-05-13
DWE12014-12-11
NEY12012-11-30
GCJ12009-09-23
DQA12007-08-13
BTM12005-12-23
DQR12005-09-12
KZE11999-04-23
IXQ11997-12-05
FRN11997-07-18

NDC#

Oxygen

Andy-Oxy Co., Inc.

Oxygen

Air

Andy-Oxy Co., Inc.

Air

IOSAT

Anbex Inc.

Potassium Iodide

IOSAT

Anbex Inc.

Potassium Iodide

OXYGEN

ANALGESIC SERVICES, INC.

OXYGEN

NITROGEN

ANALGESIC SERVICES, INC.

NITROGEN

Air

Analgesic Services Inc

Air

Otrexup

Antares Pharma, Inc.

methotrexate

Otrexup

Antares Pharma, Inc.

methotrexate

Otrexup

Antares Pharma, Inc.

methotrexate

Otrexup

Antares Pharma, Inc.

methotrexate

200 records. Showing 1-40. Next

PMA#

Monovisc High Molecular Weight Hyaluronan

2022-11-08

Anika Therapeutics, Inc.32 Wiggins Avenuebedford, MA 01730 PMA NumberP090031 Supplement NumberS015 Date Received10/12/2022 Decision Date11/08/2022 Product Code MOZ  Advisory Committee Orthopedic Supplement Type30-day Notice Supplement Reason Process Change ...

Orthovisc, Sodium Hyaluronic

2022-11-08

Anika Therapeutics, Inc.32 Wiggins Avenuebedford, MA 01730 PMA NumberP030019 Supplement NumberS027 Date Received10/12/2022 Decision Date11/08/2022 Product Code MOZ  Advisory Committee Orthopedic Supplement Type30-day Notice Supplement Reason Process Change ...

Monovisc High Molecular Weight Hyaluronan

2022-11-04

Anika Therapeutics, Inc.32 Wiggins Avenuebedford, MA 01730 PMA NumberP090031 Supplement NumberS014 Date Received10/03/2022 Decision Date11/04/2022 Product Code MOZ  Advisory Committee Orthopedic Supplement Type30-day Notice Supplement Reason Process Change ...

AngelMed Guardian System

2022-09-21

ANGEL MEDICAL SYSTEMS INC.788 Shrewsbury Ave Suite 2200tinton Falls, NJ 07724 PMA NumberP150009 Supplement NumberS008 Date Received08/19/2022 Decision Date09/21/2022 Product Code QBI  Advisory Committee Cardiovascular Supplement Typenormal 180 Day Track No ...

Monovisc High Molecular Weight Hyaluronan

2022-07-13

Anika Therapeutics, Inc.32 Wiggins Avenuebedford, MA 01730 PMA NumberP090031 Supplement NumberS013 Date Received06/17/2022 Decision Date07/13/2022 Product Code MOZ  Advisory Committee Orthopedic Supplement Type30-day Notice Supplement Reason Process Change ...

AngelMed Guardian System

2022-05-19

ANGEL MEDICAL SYSTEMS INC.788 Shrewsbury Ave Suite 2200tinton Falls, NJ 07724 PMA NumberP150009 Supplement NumberS007 Date Received04/27/2022 Decision Date05/19/2022 Product Code QBI  Advisory Committee Cardiovascular Supplement Typenormal 180 Day Track No ...

Monovisc

2020-01-09

Anika Therapeutics, Inc.

MONOVISC

2016-10-04

Anika Therapeutics, Inc.

144 records. Showing 1-40. Next

PMN#

Insulin Syringe

2023-11-30

Anhui Hongyu Wuzhou Medical Manufacturer Co., Ltd.

200 records. Showing 1-40. Next

Applications#

220420

ANNORA PHARMA PRIVATE LIMITED

218832

ANNORA PHARMA PRIVATE LIMITED

218437

ANNORA PHARMA PRIVATE LIMITED

218123

ANNORA PHARMA PRIVATE LIMITED

200 records. Showing 1-40. Next