146 results
·
32ms
·
Sources: EU EUDAMED, US FDA
AMBU SPUR II ADULT RESUSCITATOR
FDA Adverse Event
Malfunction
·Product code BTM·January 29, 2013
AMBU INC.
FDA Adverse Event
Malfunction
·AMBU, INC.·Product code BTM·February 7, 2012
SPUR II
FDA Adverse Event
Malfunction
·AMBU A/S·Product code BTM·March 25, 2010
UNOMEDICAL INC DISTRIBUTED BY KENTRON HEALTH
FDA Adverse Event
Death
·UNOMEDICAL, INC.·Product code BTM·September 16, 2011
AMBU BAG
FDA Adverse Event
Injury
·WESTMED, INC.·Product code BTM·July 10, 2006
AMBU SPUR II PEDIATRIC RESUSCITATOR
FDA Adverse Event
Malfunction
·AMBU A/S·Product code OEV·July 2, 2025
AMBU SPUR II
FDA Adverse Event
Injury
·AMBU A/S·Product code BTM·May 13, 2010
AMBU SPUR II PEDIATRIC RESUSCITATOR
FDA Adverse Event
Malfunction
·AMBU A/S·Product code OEV·July 2, 2025
KENTRON - ADULT PULMONARY RESUSCITATOR
FDA Adverse Event
Other
·UNOMEDICAL S.A. DE C.V.·Product code BTM·October 28, 2009
Ambu, Positive End Expiratory Pressure (PEEP) Valves, PEEP Valve Spare Part, REF 137 000 501, Manufacturer: Ambu International A/S, DK2750 Ballerup USA: Ambu Inc. (Ambu USA) Linthicum, MD 21090-1356 USA, Made in Denmark
FDA Recall
Terminated
·Ambu Incorporated·Product code BYE·August 21, 2007
Ambu, Positive End Expiratory Pressure (PEEP) Valves, PEEP Valve 10, 30 mm, REF 000 137 000, Manufacturer: Ambu International A/S, DK2750 Ballerup USA: Ambu Inc. (Ambu USA) Linthicum, MD 21090-1356 USA, Made in Denmark
FDA Recall
Terminated
·Ambu Incorporated·Product code BYE·August 21, 2007
Ambu, Positive End Expiratory Pressure (PEEP) Valves, PEEP Valve 10, 22/18 mm, REF 000 138 000, Manufacturer: Ambu International A/S, DK2750 Ballerup USA: Ambu Inc. (Ambu USA) Linthicum, MD 21090-1356 USA, Made in Denmark
FDA Recall
Terminated
·Ambu Incorporated·Product code BYE·August 21, 2007
Ambu, Positive End Expiratory Pressure (PEEP) Valves, PEEP Valve 10, 22/18 mm, 30mm connector, REF 137 001 000, Manufacturer: Ambu International A/S, DK2750 Ballerup USA: Ambu Inc. (Ambu USA) Linthicum, MD 21090-1356 USA, Made in Denmark
FDA Recall
Terminated
·Ambu Incorporated·Product code BYE·August 21, 2007
KING LTS-D KIT
FDA Adverse Event
Death
·KING SYSTEMS·Product code CAE·November 19, 2020
Ambu aView 2 A Monitor-The Ambu aView 2 Advance is intended to display live imaging data from compatible Ambu visualization devices, portable endoscopy system. Catalog No: 405011000
FDA Recall
Open, Classified
·Ambu Inc.·Product code FEM·July 21, 2023
RESUSCITATOR WITH MASK LF-NEO INFANT AMBU BAG
FDA Adverse Event
Malfunction
·AMBU INC. / AMBU LIMITED·Product code BTM·January 10, 2023
NEWPORT HT50 VENTILATOR
FDA Adverse Event
Malfunction
·FLIGHT MEDICAL LTD·Product code CBK·July 13, 2005
AMBU KING MASK
FDA Adverse Event
Malfunction
·AMBU, INC.·Product code BSJ·October 5, 2016
AMBU ACTION BLOCK PAIN PUMP DISPOSABLE...
FDA Adverse Event
Death
·AMBU, INC.·Product code FRN·June 18, 2014
SPUR II
FDA Adverse Event
Malfunction
·AMBU, INC·Product code BTM·April 23, 2010