Maquet Critical Care AB is one of 16501 FDA 510(k) medical device manufacturers from United States in the dataset, ranked by real submission volume.
Maquet Critical Care AB - FDA 510(k) Cleared Devices
Recent clearances: Edi Catheter ENFit 6Fr/48 cm (6893166), Servo-air Lite Ventilator System, Servo-u Ventilator System 4.1, Servo-n Ventilator System 4.1, Servo-u MR Ventilator System 4.1
20
Total
20
Cleared
0
Denied
Maquet Critical Care AB has 20 FDA 510(k) cleared anesthesiology devices. Based in Iselin, US.
Latest FDA clearance: Aug 2026. 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.
Regulatory submissions have been managed by Maquet Medical Systems USA, Getinge and Maquet Medical System USA.
FDA 510(k) Regulatory Record - Maquet Critical Care AB
20 devices
Cleared
Aug 26, 2026
Edi Catheter ENFit 6Fr/48 cm (6893166)
Gastroenterology & Urology
275d
Cleared
Jul 06, 2023
Servo-air Lite Ventilator System
Anesthesiology
167d
Cleared
Apr 20, 2021
Servo-u Ventilator System 4.1, Servo-n Ventilator System 4.1, Servo-u MR...
Anesthesiology
287d
Cleared
Mar 18, 2020
Flow-i Anesthesia System, Flow-c Anesthesia System, Flow-e Anesthesia System
Anesthesiology
335d
Cleared
Oct 21, 2019
Servo Guard
General Hospital
375d
Cleared
Mar 19, 2019
SERVO-U Ventilator System version 2.1
Anesthesiology
427d
Cleared
Mar 29, 2017
FLOW-i Anesthesia System C20, FLOW-i Anesthesia System C30, FLOW-i Anesthesia...
Anesthesiology
385d
Cleared
Mar 02, 2017
Edi Catheter ENFit
Gastroenterology & Urology
435d
Cleared
Dec 21, 2015
SERVO-U Ventilator System, SERVO-n Ventilator System
Anesthesiology
168d
Cleared
Dec 11, 2015
Guide wire for Edi Catheter 6 Fr, Guide wire for Edi Catheter 8 Fr, 100 cm,...
Gastroenterology & Urology
10d
Cleared
Jun 20, 2014
SERVO-I VENTILATOR SYSTEM
Anesthesiology
623d
Cleared
Mar 20, 2014
FLOW-I ANESTHESIA SYSTEM C20, C30 & C40
Anesthesiology
86d