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. Anesthesiology ✕

25 devices

1-12 of 25

Cleared Nov 15, 2004

AMBU SPUR II. ADULT SINGLE PATIENT RESUSCITATOR

Anesthesiology · 47d

Cleared Nov 12, 2004

AMBU SPUR II INFANT AND PEDIATRIC SINGLE PATIENT USE RESUSCITATORS

Anesthesiology · 29d

Cleared Jul 22, 2004

AMBU DISPOSABLE PRESSURE MANOMETER

Anesthesiology · 97d

Cleared May 17, 2000

AMBU NEONATE SILICONE RESUSCITATOR

Anesthesiology · 230d

Cleared Oct 25, 1999

AMBU HAND POWER SUCTION PUMP

Anesthesiology · 56d

Cleared Apr 12, 1999

AMBU MEDIBAG ADULT, AMBU MEDIBAG INFANT/CHILD

Anesthesiology · 250d

Cleared Jul 17, 1998

Anesthesiology · 49d

Cleared May 15, 1997

AMBU SPUR NEONATE

Anesthesiology · 181d

Cleared Jun 22, 1993

AMBU DISPOSABLE FACE MASK

Anesthesiology · 60d

Cleared Feb 05, 1993

SPUR INFANT/CHILD W/O PRESSURE-LIMITING VALVE

Anesthesiology · 192d

Cleared Jan 05, 1993

AMBU SINGLE PATIENT USE PEEP VALVE

Anesthesiology · 151d

Cleared Sep 16, 1992

AMBU SILICONE RESUSCITATOR, ADULT W/OPEN RESERVOIR

Anesthesiology · 43d