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Maquet Critical Care AB

FDA 510(k) & PMA Approved Devices — 16 products

Total Devices16
Categories0
Latest FDA decision
TypeNumberDevice NameCodeDateActions
510(k) K253715 Edi Catheter ENFit 6Fr/48 cm (6893166); Edi Catheter ENFit 6Fr/49cm (6893273); Edi Catheter ENFit 6Fr/50cm (6893274); Edi Catheter ENFit 8Fr/50cm (6893275); Edi Catheter ENFit 8Fr/100cm (6893276); Edi Catheter ENFit 8Fr/125cm (6893277); Edi Catheter ENFit 12Fr/125cm (6893278); Edi Catheter ENFit 16Fr/125cm (6893279)PIF2026-08-26 View
510(k) K230173 Servo-air Lite Ventilator SystemMNT2023-07-06 View
510(k) K201874 Servo-u Ventilator System 4.1, Servo-n Ventilator System 4.1, Servo-u MR Ventilator System 4.1CBK2021-04-20 View
510(k) K191027 Flow-i Anesthesia System, Flow-c Anesthesia System, Flow-e Anesthesia SystemBSZ2020-03-18 View
510(k) K182862 Servo GuardCAH2019-10-21 View
510(k) K180098 SERVO-U Ventilator System version 2.1; SERVO-n Ventilator System version 2.1CBK2019-03-19 View
510(k) K160665 FLOW-i Anesthesia System C20, FLOW-i Anesthesia System C30, FLOW-i Anesthesia System C40BSZ2017-03-29 View
510(k) K153688 Edi Catheter ENFitPIF2017-03-02 View
510(k) K112114 MAQUET FLOW-I C20, MAQUET FLOW-I C30, MAQUET FLOW-I C40BSZ2012-01-13 View
510(k) K102182 MAQUET FLOW-I C20, MAQUET FLOW-I C30, MODEL 66 77 200, 66 77 30BSZ2011-05-09 View
510(k) K101199 GUIDE WIRE FOR EDI CATHETER, 8FR,125CM,5 EACH,GUIDE WIRE FOR EDI CATHETER, 8FR,125CM,5 EACH,GUIDE WIRE FOR EDI CATHETER,KNT2010-08-27 View
510(k) K073179 SERVO-I VENTILATOR SYSTEM MODEL 64 87 800 E4073, HELIOX OPTION, MODEL 6675585CBK2008-06-09 View
510(k) K063404 SERVO-I VENTILATOR SYSTEM, MODELS 64, 87 AND 800CBK2007-02-15 View
510(k) K062793 SERVO-I VENTILATOR SYSTEM, MODEL 64 87 800 E407E; NAVA OPTIONCBK2007-02-07 View
510(k) K041223 MODIFICATION TO SERVO-I VENTILATOR SYSTEM, MODEL 64 87 800 E407ECBK2004-07-29 View
510(k) K040221 SERVO-I VENTILATOR SYSTEM, MODEL 64 87 800 E407ECBK2004-02-20 View
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