Maquet Critical Care AB

FDA Regulatory Profile

Summary

Total Recalls
3 (3 Class I)
510(k) Clearances
19
Inspections
2
Compliance Actions
0

Recent Recalls

NumberClassProductDate
Z-2015-2025Class IServo-u MR Ventilator System. Model Number: 6888800.May 30, 2025
Z-2013-2025Class IServo-u Ventilator System. Model Number: 6688600.May 30, 2025
Z-2014-2025Class IServo-n Ventilator System. Model Number: 6694800.May 30, 2025

Recent 510(k) Clearances

K-NumberDeviceDate
K230173Servo-air Lite Ventilator SystemJuly 6, 2023
K201874Servo-u Ventilator System 4.1, Servo-n Ventilator System 4.1, Servo-u MR Ventilator System 4.1April 20, 2021
K191027Flow-i Anesthesia System, Flow-c Anesthesia System, Flow-e Anesthesia SystemMarch 18, 2020
K182862Servo GuardOctober 21, 2019
K180098SERVO-U Ventilator System version 2.1; SERVO-n Ventilator System version 2.1March 19, 2019
K160665FLOW-i Anesthesia System C20, FLOW-i Anesthesia System C30, FLOW-i Anesthesia System C40March 29, 2017
K153688Edi Catheter ENFitMarch 2, 2017
K151814SERVO-U Ventilator System, SERVO-n Ventilator SystemDecember 21, 2015
K153461Guide wire for Edi Catheter 6 Fr, Guide wire for Edi Catheter 8 Fr, 100 cm, Guide wire for Edi CatheDecember 11, 2015
K123149SERVO-I VENTILATOR SYSTEMJune 20, 2014
K133958FLOW-I ANESTHESIA SYSTEM C20, C30 & C40March 20, 2014
K112114MAQUET FLOW-I C20, MAQUET FLOW-I C30, MAQUET FLOW-I C40January 13, 2012
K102182MAQUET FLOW-I C20, MAQUET FLOW-I C30, MODEL 66 77 200, 66 77 30May 9, 2011
K101199GUIDE WIRE FOR EDI CATHETER, 8FR,125CM,5 EACH,GUIDE WIRE FOR EDI CATHETER, 8FR,125CM,5 EACH,GUIDE WIAugust 27, 2010
K073179SERVO-I VENTILATOR SYSTEM MODEL 64 87 800 E4073, HELIOX OPTION, MODEL 6675585June 9, 2008
K063404SERVO-I VENTILATOR SYSTEM, MODELS 64, 87 AND 800February 15, 2007
K062793SERVO-I VENTILATOR SYSTEM, MODEL 64 87 800 E407E; NAVA OPTIONFebruary 7, 2007
K041223MODIFICATION TO SERVO-I VENTILATOR SYSTEM, MODEL 64 87 800 E407EJuly 29, 2004
K040221SERVO-I VENTILATOR SYSTEM, MODEL 64 87 800 E407EFebruary 20, 2004