Ambu A/S - FDA 510(k) Cleared Devices
39
Total
39
Cleared
0
Denied
39 devices
Cleared
Aug 29, 2016
Ambu SPUR II Adult Resuscitator, Ambu SPUR II Pediatric Resuscitator, Ambu...
Anesthesiology
329d
Cleared
Aug 17, 2016
Ambu USR, Ambu M
Gastroenterology & Urology
149d
Cleared
Nov 01, 2013
AMBU ASCOPE 3 5.0/2.2
Ear, Nose, Throat
220d
Cleared
Nov 18, 2011
AMBU ASCOPE 2
Anesthesiology
226d
Cleared
Jan 28, 2011
AMBU OVAL SILICONE RESUSCITATOR, ADULT AND PEDIATRIC
Anesthesiology
121d
Cleared
Jun 11, 2010
AMBU BLUE SENSOR NEO, AMBU BLUE SENSOR NEO X
Cardiovascular
143d
Cleared
Apr 16, 2010
AMBU ASCOPE AND MONITOR
Anesthesiology
189d
Cleared
Jan 13, 2010
AMBU NEUROLINE DISPOSABLE INOJECT NEEDLE ELECTRODE
Neurology
30d
Cleared
Jul 30, 2007
MODIFICATION TO: AMBU NEUROLINE CONCENTRIC NEEDLE ELECTRODE
Neurology
91d
Cleared
May 30, 2007
MODIFICATION TO: AMBU NEUROLINE, DISPOSABLE MONOPOLAR NEEDLE ELECTRODE
Neurology
30d
Cleared
Oct 25, 2006
AMBU WHITE SENSOR CFM, CFL
Cardiovascular
370d
Cleared
Oct 25, 2006
AMBU BLUE SENSOR NEO AND NEO X
Cardiovascular
309d
Cleared
Dec 23, 2005
AMBU MARK IV RESUSCITATOR
Anesthesiology
44d
Cleared
Dec 20, 2005
AMBU MARK IV BABY RESUSCITATOR
Anesthesiology
41d