Ambu, Inc. - FDA 510(k) Cleared Devices
33
Total
33
Cleared
0
Denied
25 devices
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
AMBU TUBECHECK
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
Cleared
Sep 16, 1992
AMBU SILICONE RESUSCITATOR INFAN/CHILD W/OPEN RESO
Anesthesiology
43d
Cleared
Jun 19, 1992
SPUR ADULT WITH OPEN RESERVOIR SYSTEM
Anesthesiology
14d
Cleared
Jun 19, 1992
SPUR INFANT/CHILD WITH OPEN RESERVOIR SYSTEM
Anesthesiology
14d
Cleared
Oct 07, 1991
AMBU SILICONE RESUSCITATOR INFANT/CHILD
Anesthesiology
19d
Cleared
May 28, 1991
AMBU MATIC AUTOMATIC RESUSCITATOR
Anesthesiology
209d
Cleared
May 28, 1991
AMBU SIR 2 (SILICONE RESUSCITATOR), ADULT
Anesthesiology
144d
Cleared
Jul 16, 1990
AMBU SPUR (SINGLE PATIENT USE RESUSCITATOR) INFANT
Anesthesiology
56d
Cleared
Jun 08, 1990
AMBU LIFE KEY AND AMBU RES-CUE KEY
Anesthesiology
142d
Cleared
Sep 14, 1988
AMBU SPUR (SINGLE PATIENT USE RESUSCITATOR)
Anesthesiology
30d
Cleared
Dec 30, 1987
AMBU RMT VALVE
Anesthesiology
118d
Cleared
Apr 15, 1985
AMBU CPAP SYSTEM
Anesthesiology
20d
Cleared
Nov 15, 1984
AMBU RUBEN CIRCLE ANESTHESIA SYSTEM
Anesthesiology
22d
Cleared
Feb 10, 1984
MARK III RESUSCITATOR
Anesthesiology
15d