Medical Device Manufacturer · US , Walker , MI

Ambu, Inc. - FDA 510(k) Cleared Devices

33 submissions · 33 cleared · Since 1984

33

Total

33

Cleared

0

Denied

FDA 510(k) Regulatory Record - Ambu, Inc. General & Plastic Surgery ✕

3 devices

1-3 of 3

Cleared May 25, 2001

AMBU GEL, HYDROGEL BURN DRESSING

General & Plastic Surgery · 87d

Cleared May 05, 1995

AMBU PORTABLE SUCTION UNIT

General & Plastic Surgery · 738d

Cleared Sep 02, 1988

AMBU TWIN PUMP - (MANUAL SUCTION PUMP)

General & Plastic Surgery · 18d