Maquet Critical Care Ab

FDA Filings

This page includes the latest FDA filings for Maquet Critical Care Ab. Currently, you will find the latest 100 filings for Premarket Notifications, Premarket Applications, De Novo Applications, and GUDID registrations.

FDA Registration(s)
Registration Number8010042
FEI Number3002808128
NameMAQUET CRITICAL CARE AB
Owner & OperatorMAQUET CRITICAL CARE AB
Contact AddressROENTGENVAGEN 2 --
SOLNA SE-AB Stockholms lan [SE-01] SE-17154 SE
Official Correspondent
  • Dennis - Genito
  • 046-70-7827852-x
US Agent
Registration Status1
Initial ImporterN
Registration Expiration2020-04-25
Registration AddressROENTGENVAGEN 2
SOLNA Stockholms lan [SE-01], S-17154 SE
Establishment Type
  • Manufacture Medical Device
  • Export Device to the United States But Perform No Other Operation on Device
  • Develop Specifications But Do Not Manufacture At This Facility
  • Complaint File Establishment per 21 CFR 820.198



FDA Filings

Device
Company
DeviceDate
Maquet Critical Care AB
Drawer for Low mobile carts 2023-12-18
Maquet Critical Care AB
Servo-air Lite 2023-09-29
Maquet Critical Care AB
Compressor Mini 115V 60Hz 2023-09-29
Maquet Critical Care AB
Base Unit Servo-u MR 2021-12-09
Maquet Critical Care AB
Heliox Servo adapter kit 2021-06-28
Maquet Critical Care AB
Servo-u Ventilator System 4.1, Servo-n Ventilator System 4.1, Servo-u MR Ventilator System 4.12021-04-20
Maquet Critical Care AB
Dust filter 20 pcs/pkg 2020-09-24
Maquet Critical Care AB
Humidifier holder for rail 10 x 25/10 x 30 mm 2020-09-24
Maquet Critical Care AB
Cabinet 2020-09-24
Maquet Critical Care AB
Support arm 179 2020-09-24
Maquet Critical Care AB
Shelf base, Servo-air 2020-09-24
Maquet Critical Care AB
Mobile Cart, Flat Pack Servo-air 2020-09-24
Maquet Critical Care AB
Battery module 2020-09-24
Maquet Critical Care AB
Base unit, Servo-air 2020-09-24
Maquet Critical Care AB
Air inlet filter 2020-09-24
Maquet Critical Care AB
AFGO kit (onsite upgrade) 2020-06-03
Maquet Critical Care AB
CO2 absorber (disposable), 12 pcs/pkg 2020-06-03
Maquet Critical Care AB
Extra Volume reflector 2020-06-03
Maquet Critical Care AB
Flow-i C40 Anesthesia System 2020-06-03
Maquet Critical Care AB
Flow-i C30 Anesthesia System 2020-06-03
Maquet Critical Care AB
Flow-i C20 Anesthesia System 2020-06-03
Maquet Critical Care AB
AFGO adapter kit onsite upgrade 2020-06-03
Maquet Critical Care AB
Flow-e Anesthesia System 2020-06-03
Maquet Critical Care AB
Suction tip holder 2020-06-03
Maquet Critical Care AB
Tubing hook small 2020-06-03
Maquet Critical Care AB
Tubing hook large 2020-06-03
Maquet Critical Care AB
Flexible manual breathing bag arm 2020-06-03
Maquet Critical Care AB
Horizontal short rail DIN 2020-06-03
Maquet Critical Care AB
Volume reflector 2020-06-03
Maquet Critical Care AB
Vaporizer Sevoflurane, SAFE-T-SEAL 2020-06-03
Maquet Critical Care AB
Vaporizer Sevoflurane, MAQUET filling 2020-06-03
Maquet Critical Care AB
Vaporizer Desflurane, Saf-Fil 2020-06-03
Maquet Critical Care AB
Vaporizer Isoflurane, MAQUET filling 2020-06-03
Maquet Critical Care AB
Vaporizer Sevoflurane, QUICK FILL 2020-06-03
Maquet Critical Care AB
Volu.reflec, incl.Reflector socket 2020-04-07
MAQUET CRITICAL CARE AB
Flow Family Anesthesia System 4.7; Models Flow-c, Flow-e, Flow-i2020-03-26
Maquet Critical Care AB
Flow-i Anesthesia System, Flow-c Anesthesia System, Flow-e Anesthesia System2020-03-18
Maquet Critical Care AB
Hytrel slang 10mm 30cm 2019-12-11
Maquet Critical Care AB
Flextub Hytrel 15mm 15cm 2019-12-11
Maquet Critical Care AB
Breath syst 10mm Heater Humidif.Si 2019-12-11
Maquet Critical Care AB
Breath syst 10mm (Aktive Humid)Hytr 2019-12-11
Maquet Critical Care AB
Breath syst 15mm (Aktive Humid)Hytr 2019-12-11
Maquet Critical Care AB
Pat syst 10mm HME Hytrel Reus 1.5m 2019-12-11
Maquet Critical Care AB
Breath syst 10mm (Aktive Humid)Sili 2019-12-11
Maquet Critical Care AB
Pat syst 15mm HME Hytrel Reus 1.5m 2019-12-11
Maquet Critical Care AB
Pat syst 22mm HME HME Si Reus 1.5m 2019-12-11
Maquet Critical Care AB
Pat syst 22mm HME Hytrel Reus 1.5m 2019-12-11
Maquet Critical Care AB
Breathing system 15mm HME Disp 1.2m 2019-11-27
Maquet Critical Care AB
Breath circuit 10 disp 1.2m 2019-11-27
Maquet Critical Care AB
Breath syst 10mm Act Disp 2.2m10pcs 2019-11-27
Maquet Critical Care AB
Breath syst 22mm HME & MR 3M Disp 2019-11-27
Maquet Critical Care AB
Breath syst 10mm HME Disp1.2m 2019-11-27
Maquet Critical Care AB
Breath syst 10mm HME & MR 3M Disp 2019-11-27
Maquet Critical Care AB
Breath syst 15mm HME & MR 3M Disp 2019-11-27
Maquet Critical Care AB
Breath circuit 15 disp 1.2m 2019-11-27
Maquet Critical Care AB
Breath circuit 22 disp 1.5m 2019-11-27
Maquet Critical Care AB
Breathing system 22mm HME Disp 1.5m 2019-11-27
Maquet Critical Care AB
Breath syst 22mm Act Disp2.1m 10pcs 2019-11-27
Maquet Critical Care AB
Breath syst 22mm Heater Humidif.Si 2019-11-27
Maquet Critical Care AB
Breath syst 22mm (Aktive Humid)Sili 2019-11-27
Maquet Critical Care AB
Breath syst 22mm (Aktive Humid)Hytr 2019-11-27
Maquet Critical Care AB
Servo Guard2019-10-21
Maquet Critical Care AB
Guide Wire for Edi catheter 6Fr/ 49 and 50 cm 2019-09-30
Maquet Critical Care AB
Guide Wire for Edi catheter 8Fr/125 cm 2019-09-30
Maquet Critical Care AB
Guide Wire for Edi catheter 8Fr/100 cm 2019-09-30
Maquet Critical Care AB
Y sensor neonatal, disposable, 5 pcs/pkg 2019-05-28
Maquet Critical Care AB
Y SENSOR PRESSURE LINE 2019-05-28
Maquet Critical Care AB
THERMOSHELL, EXP CASSETTE 2019-05-28
Maquet Critical Care AB
Y-PIECE W/SAMPL. PORT 2019-05-28
Maquet Critical Care AB
CO2 ANALYZER MODULE CAPNOSTAT 5 2019-05-28
Maquet Critical Care AB
GAS CYLINDER RESTRAINER KIT US 2019-05-28
Maquet Critical Care AB
Universal Holder assy 2019-05-28
Maquet Critical Care AB
Rail clamp 10x25, Humidifier holder 2019-05-28
Maquet Critical Care AB
Humidification holder assy 2019-05-28
Maquet Critical Care AB
CAPNOSTAT 5 2019-05-28
Maquet Critical Care AB
Y PIECE HOLDER/HOOK SERVO VENT HANDL 2019-05-28
Maquet Critical Care AB
CO2 ANALYZER MODULE 2019-05-28
Maquet Critical Care AB
WATERBAG/IV POLE 2019-05-28
Maquet Critical Care AB
Base Unit SERVO-n 2019-05-28
Maquet Critical Care AB
MOBILE CART 2019-05-28
Maquet Critical Care AB
PENDANT BED/HOLDER 2019-05-28
Maquet Critical Care AB
SHELF BASE 2019-05-28
Maquet Critical Care AB
HUMIDIFIER HOLDER 2019-05-28
Maquet Critical Care AB
USER INTERFACE HOLDER 2019-05-28
Maquet Critical Care AB
CABLE HOLDER 2019-05-28
Maquet Critical Care AB
Support Arm 178 2019-05-28
Maquet Critical Care AB
Y sensor module, SERVO-U/-n 2019-05-28
Maquet Critical Care AB
TELEFLEX ADAPTER, HUMIDIFIER HOLDER 2019-05-28
Maquet Critical Care AB
EXPIRATORY CASSETTE, DARK GRAY 2019-04-17
Maquet Critical Care AB
EXPIRATORY CASSETTE, SERVO-n 2019-04-17
Maquet Critical Care AB
BASE UNIT SERVO-U 2019-04-17
MAQUET CRITICAL CARE AB
Servo-u/n2019-03-27
Maquet Critical Care AB
SERVO-U Ventilator System Version 2.1; SERVO-n Ventilator System Version 2.12019-03-19
Maquet Critical Care AB
High Pressure hose Heliox NIST 5m 2018-12-21
Maquet Critical Care AB
Servo duo guard 1pcs 2018-10-10
Maquet Critical Care AB
Servo Guard 1pcs 2018-10-10
Maquet Critical Care AB
Absorber sealing, 2 each 2018-07-06
Maquet Critical Care AB
Water Trap Dryline A KMG2000 10each 2018-07-06
Maquet Critical Care AB
Sampling Line 2,5m 25Pc 2018-07-06
Maquet Critical Care AB
Patient cassette complete 2018-07-06
Maquet Critical Care AB
GAS CYLINDER RESTRAINER KIT 2018-07-06
Maquet Critical Care AB
Vaporizer Sevoflurane, QUIK FIL 2018-07-06
Maquet Critical Care AB
Vaporizer Isoflur. Maquet filling 2018-07-06
Maquet Critical Care AB
Conn Tube 22mm Int 50m disposable 2018-07-06
Maquet Critical Care AB
Adjustable arm for param. modules 2018-07-06
Maquet Critical Care AB
Vaporizer Sevoflur. Maquet filling 2018-07-06
MAQUET CRITICAL CARE AB
FLOW-i 4.22017-03-31
MAQUET CRITICAL CARE AB
Edi Catheter ENFit2017-03-31
MAQUET CRITICAL CARE AB
Edi Catheter ENFit2017-03-31
MAQUET CRITICAL CARE AB
FLOW-i Anesthesia System C20, FLOW-i Anesthesia System C30, FLOW-i Anesthesia System C402017-03-29
MAQUET CRITICAL CARE AB
Edi Catheter ENFit2017-03-02
MAQUET CRITICAL CARE AB
SERVO-U/n2015-12-22
MAQUET CRITICAL CARE AB
SERVO-U Ventilator System, SERVO-n Ventilator System2015-12-21
MAQUET CRITICAL CARE AB
Guide Wire For Edi Catheter 6 Fr, Guide Wire For Edi Catheter 8 Fr, 100 Cm, Guide Wire For Edi Catheter 8 Fr, 125 Cm2015-12-11
MAQUET CRITICAL CARE AB
MR8502015-10-27
MAQUET CRITICAL CARE AB
Absorber FLOW-i2015-10-16
MAQUET CRITICAL CARE AB
Miniflow adapter Nasal prongs size XS, S, M, M-wide, L, XL, L-wide2015-05-28
MAQUET CRITICAL CARE AB
FLOW-i C402015-02-06
MAQUET CRITICAL CARE AB
FLOW-i C302015-02-06
MAQUET CRITICAL CARE AB
FLOW-i C202015-02-06
MAQUET CRITICAL CARE AB
SERVO-I VENTILATOR SYSTEM2014-06-20
MAQUET CRITICAL CARE AB
FLOW-I ANESTHESIA SYSTEM C20, C30 & C402014-03-20
MAQUET CRITICAL CARE AB
Servo Humidifier 1732013-06-26
MAQUET CRITICAL CARE AB
Servo Humidifier 1722013-06-26
MAQUET CRITICAL CARE AB
Servo Humidifier 1632013-06-26
MAQUET CRITICAL CARE AB
Servo Humidifier 1622013-06-26
MAQUET CRITICAL CARE AB
Servo Humidifier 1612013-06-26
MAQUET CRITICAL CARE AB
Set of breathing circuit anesthesia2012-08-31
MAQUET CRITICAL CARE AB
Gas samplning line2012-08-31
MAQUET CRITICAL CARE AB
Breathing system2012-08-31
MAQUET CRITICAL CARE AB
Breathing circuit2012-08-31
MAQUET CRITICAL CARE AB
Watertrap reusable2012-08-31
MAQUET CRITICAL CARE AB
Breathing Bag set Anesthesia, Reusable2012-08-31
MAQUET CRITICAL CARE AB
Breathing Bag Anesthesia, Reusable2012-08-31
MAQUET CRITICAL CARE AB
Breathing Bag Anesthesia, Disposable2012-08-31
MAQUET CRITICAL CARE AB
Anesthesia mask, Reusable2012-08-31
MAQUET CRITICAL CARE AB
Anesthesia mask, Disposable2012-08-31
MAQUET CRITICAL CARE AB
MAQUET FLOW-I C20, MAQUET FLOW-I C30, MAQUET FLOW-I C402012-01-13
MAQUET CRITICAL CARE AB
MAQUET FLOW-I C20, MAQUET FLOW-I C30, MODEL 66 77 200, 66 77 302011-05-09
MAQUET CRITICAL CARE AB
GUIDE WIRE FOR EDI CATHETER, 8FR,125CM,5 EACH,GUIDE WIRE FOR EDI CATHETER, 8FR,125CM,5 EACH,GUIDE WIRE FOR EDI CATHETER,2010-08-27
MAQUET CRITICAL CARE AB
SERVO-I VENTILATOR SYSTEM MODEL 64 87 800 E4073, HELIOX OPTION, MODEL 66755852008-06-09
MAQUET CRITICAL CARE AB
Servo Guard2008-02-19
MAQUET CRITICAL CARE AB
SERVO-I VENTILATOR SYSTEM, MODELS 64, 87 AND 8002007-02-15
MAQUET CRITICAL CARE AB
SERVO-I VENTILATOR SYSTEM, MODEL 64 87 800 E407E; NAVA OPTION2007-02-07
MAQUET CRITICAL CARE AB
MODIFICATION TO SERVO-I VENTILATOR SYSTEM, MODEL 64 87 800 E407E2004-07-29
MAQUET CRITICAL CARE AB
SERVO-I VENTILATOR SYSTEM, MODEL 64 87 800 E407E2004-02-20

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