Maquet Critical Care AB
Maquet Critical Care AB holds FDA 510(k) medical device clearances, first cleared 2004, most recent 2026, with 5 FDA device recalls on record.
Top product codes for Maquet Critical Care AB
FDA recalls by Maquet Critical Care AB
- Z-2963-2026 — GETINGE Y SENSOR Module, SERVO-U, SERVO-N, Model Number 6693662; part of the SERVO-U/-N continuous ventilator system, for facility use. Maquet Critical Care AB, is a subsidiary of Getinge.
- Z-2860-2026 — Flow Anesthesia Machine Flow-i C20 6677200 Flow-i C30 6677300 Flow-i C40 6677400 Flow-i C20 6888520 Flow-i C30 6888530 Flow-i C40 6888540 Flow-c 6887700 Flow-e 6887900
- Z-2014-2025 — Servo-n Ventilator System. Model Number: 6694800.
- Z-2013-2025 — Servo-u Ventilator System. Model Number: 6688600.
- Z-2015-2025 — Servo-u MR Ventilator System. Model Number: 6888800.
Recalls are matched by FDA's recalling-firm name — openFDA's enforcement dataset doesn't reference 510(k) numbers, so a recall here may cover devices beyond this company's 510(k) clearances.
Recent clearances by Maquet Critical Care AB
- K253715 — Edi Catheter ENFit 6Fr/48 cm (6893166) +7 more
- K230173 — Servo-air Lite Ventilator System
- K201874 — Servo-u Ventilator System 4.1, Servo-n Ventilator System 4.1, Servo-u MR Ventilator System 4.1
- K191027 — Flow-i Anesthesia System, Flow-c Anesthesia System, Flow-e Anesthesia System
- K182862 — Servo Guard
- K180098 — SERVO-U Ventilator System version 2.1; SERVO-n Ventilator System version 2.1
- K160665 — FLOW-i Anesthesia System C20, FLOW-i Anesthesia System C30, FLOW-i Anesthesia System C40
- K153688 — Edi Catheter ENFit
- K151814 — SERVO-U Ventilator System, SERVO-n Ventilator System
- K153461 — Guide wire for Edi Catheter 6 Fr, Guide wire for Edi Catheter 8 Fr, 100 cm, Guide wire for Edi Catheter 8 Fr, 125 cm
- K123149 — SERVO-I VENTILATOR SYSTEM
- K133958 — FLOW-I ANESTHESIA SYSTEM C20, C30 & C40
- K112114 — MAQUET FLOW-I C20, MAQUET FLOW-I C30, MAQUET FLOW-I C40
- K102182 — MAQUET FLOW-I C20, MAQUET FLOW-I C30, MODEL 66 77 200, 66 77 30
- K101199 — GUIDE WIRE FOR EDI CATHETER, 8FR,125CM,5 EACH,GUIDE WIRE FOR EDI CATHETER, 8FR,125CM,5 EACH,GUIDE WIRE FOR EDI CATHETER,
- K073179 — SERVO-I VENTILATOR SYSTEM MODEL 64 87 800 E4073, HELIOX OPTION, MODEL 6675585
- K063404 — SERVO-I VENTILATOR SYSTEM, MODELS 64, 87 AND 800
- K062793 — SERVO-I VENTILATOR SYSTEM, MODEL 64 87 800 E407E; NAVA OPTION
- K041223 — MODIFICATION TO SERVO-I VENTILATOR SYSTEM, MODEL 64 87 800 E407E
- K040221 — SERVO-I VENTILATOR SYSTEM, MODEL 64 87 800 E407E
Data sourced from openFDA. This site is unofficial and independent of the FDA.