Medical Device Manufacturer · US , Iselin , NJ

Maquet Critical Care AB - FDA 510(k) Cleared Devices

19 submissions · 19 cleared · Since 2004
19
Total
19
Cleared
0
Denied

Maquet Critical Care AB has 19 FDA 510(k) cleared anesthesiology devices. Based in Iselin, US.

Last cleared in 2023. Active since 2004.

Browse the complete list of FDA 510(k) cleared anesthesiology devices from this manufacturer. Filter by specialty or product code using the sidebar.

510(k) submissions have been managed by Getinge as regulatory consultant.

FDA 510(k) Regulatory Record - Maquet Critical Care AB
19 devices
1-19 of 19
Cleared Jul 06, 2023
Servo-air Lite Ventilator System
K230173 · MNT
Anesthesiology · 167d
Cleared Apr 20, 2021
Servo-u Ventilator System 4.1, Servo-n Ventilator System 4.1, Servo-u MR...
K201874 · CBK
Anesthesiology · 287d
Cleared Mar 18, 2020
Flow-i Anesthesia System, Flow-c Anesthesia System, Flow-e Anesthesia System
K191027 · BSZ
Anesthesiology · 335d
Cleared Oct 21, 2019
Servo Guard
K182862 · CAH
General Hospital · 375d
Cleared Mar 19, 2019
SERVO-U Ventilator System version 2.1
K180098 · CBK
Anesthesiology · 427d
Cleared Mar 29, 2017
FLOW-i Anesthesia System C20, FLOW-i Anesthesia System C30, FLOW-i Anesthesia...
K160665 · BSZ
Anesthesiology · 385d
Cleared Mar 02, 2017
Edi Catheter ENFit
K153688 · PIF
Gastroenterology & Urology · 435d
Cleared Dec 21, 2015
SERVO-U Ventilator System, SERVO-n Ventilator System
K151814 · CBK
Anesthesiology · 168d
Cleared Dec 11, 2015
Guide wire for Edi Catheter 6 Fr, Guide wire for Edi Catheter 8 Fr, 100 cm,...
K153461 · KNT
Gastroenterology & Urology · 10d
Cleared Jun 20, 2014
SERVO-I VENTILATOR SYSTEM
K123149 · CBK
Anesthesiology · 623d
Cleared Mar 20, 2014
FLOW-I ANESTHESIA SYSTEM C20, C30 & C40
K133958 · BSZ
Anesthesiology · 86d
Cleared Jan 13, 2012
MAQUET FLOW-I C20, MAQUET FLOW-I C30, MAQUET FLOW-I C40
K112114 · BSZ
Anesthesiology · 172d
Cleared May 09, 2011
MAQUET FLOW-I C20, MAQUET FLOW-I C30, MODEL 66 77 200, 66 77 30
K102182 · BSZ
Anesthesiology · 279d
Cleared Aug 27, 2010
GUIDE WIRE FOR EDI CATHETER, 8FR,125CM,5 EACH,GUIDE WIRE FOR EDI CATHETER,...
K101199 · KNT
Gastroenterology & Urology · 120d
Cleared Jun 09, 2008
SERVO-I VENTILATOR SYSTEM MODEL 64 87 800 E4073, HELIOX OPTION, MODEL 6675585
K073179 · CBK
Anesthesiology · 209d
Cleared Feb 15, 2007
SERVO-I VENTILATOR SYSTEM, MODELS 64, 87 AND 800
K063404 · CBK
Anesthesiology · 98d
Cleared Feb 07, 2007
SERVO-I VENTILATOR SYSTEM, MODEL 64 87 800 E407E
K062793 · CBK
Anesthesiology · 142d
Cleared Jul 29, 2004
MODIFICATION TO SERVO-I VENTILATOR SYSTEM, MODEL 64 87 800 E407E
K041223 · CBK
Anesthesiology · 80d
Cleared Feb 20, 2004
SERVO-I VENTILATOR SYSTEM, MODEL 64 87 800 E407E
K040221 · CBK
Anesthesiology · 18d
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