Medical Device Manufacturer · US , Iselin , NJ

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

20 submissions · 20 cleared · Since 2004

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

FDA 510(k) Regulatory Record - Maquet Critical Care AB Gastroenterology & Urology ✕

4 devices

1-4 of 4

Cleared Aug 26, 2026

Edi Catheter ENFit 6Fr/48 cm (6893166)

Gastroenterology & Urology · 275d

Cleared Mar 02, 2017

Edi Catheter ENFit

Gastroenterology & Urology · 435d

Cleared Dec 11, 2015

Guide wire for Edi Catheter 6 Fr, Guide wire for Edi Catheter 8 Fr, 100 cm,...

Gastroenterology & Urology · 10d

Cleared Aug 27, 2010

GUIDE WIRE FOR EDI CATHETER, 8FR,125CM,5 EACH,GUIDE WIRE FOR EDI CATHETER,...

Gastroenterology & Urology · 120d