Ambu, Inc. is one of 5511 FDA 510(k) medical device manufacturers from United States in the dataset, ranked by real submission volume.
Ambu, Inc. - FDA 510(k) Cleared Devices
Recent clearances: AMBU NEUROLINE GROUND, AMBU SPUR II. ADULT SINGLE PATIENT RESUSCITATOR, AMBU SPUR II INFANT AND PEDIATRIC SINGLE PATIENT USE RESUSCITATORS
33
Total
33
Cleared
0
Denied
Ambu, Inc. has 33 FDA 510(k) cleared anesthesiology devices. Based in Walker, US.
Historical record: 33 cleared submissions from 1984 to 2005.
Browse the complete list of FDA 510(k) cleared anesthesiology devices from this manufacturer. Filter by specialty or product code using the sidebar.
FDA 510(k) Regulatory Record - Ambu, Inc.
33 devices
Cleared
Aug 04, 2005
AMBU NEUROLINE GROUND
Neurology
56d
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
Sep 22, 2004
AMBU DISPOSABLE ECG ELECTRODE
Cardiovascular
89d
Cleared
Jul 22, 2004
AMBU DISPOSABLE PRESSURE MANOMETER
Anesthesiology
97d
Cleared
Jun 28, 2004
AMBU BLUE SENSOR, MRX, ECG ELECTRODE PRODUCT #:MRX-00-S
Cardiovascular
68d
Cleared
Mar 05, 2004
AMBU NEUROLINE SINGLE PATIENT EEG/EP CUP ELECTRODE
Neurology
225d
Cleared
Feb 27, 2004
AMBU PEDIATRIC MULTI-FUNCTION DEFIBRILLATION ELECTRODE
Cardiovascular
206d
Cleared
May 25, 2001
AMBU GEL, HYDROGEL BURN DRESSING
General & Plastic Surgery
87d
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