16 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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RS SAFE WHITE NITRILE MEDICAL EXAMINATION GLOVES POWDER FREE OR OTHER PROPRIETARY NAME
FDA 510(k)
FDA Class 1
·General Hospital
ABI VEST AIRWAY CLEARANCE SYSTEM
FDA 510(k)
FDA Class 2
·Anesthesiology
BODY ANALYSIS SCALE, MODEL BG 17
FDA 510(k)
FDA Class 2
·Cardiovascular
PRECISION
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC NEUROMODULATION·Product code LGW·December 2, 2020
AUTOPULSE RESUSCITATION SYSTEM MODEL 100
FDA Adverse Event
Malfunction
·ZOLL CIRCULATION, INC.·Product code DRM·June 3, 2013
LC4200 PCA PLUS AUST
FDA Adverse Event
Malfunction
·HOSPIRA COSTA RICA LTD.·Product code FPA·March 8, 2012
LC4200 PCA AUST
FDA Adverse Event
Malfunction
·HOSPIRA, INC.·Product code MEA·October 20, 2010
PCA PUMP (AUZ)
FDA Adverse Event
Malfunction
·HOSPIRA COSTA RICA LTD.·Product code MEA·March 13, 2012
AUTOPULSE LI-ION BATTERY
FDA Adverse Event
Malfunction
·ZOLL CIRCULATION, INC.·Product code DRM·May 23, 2013
LC4200 PCA PLUS AUST
FDA Adverse Event
Injury
·HOSPIRA COSTA RICA LTD.·Product code MEA·March 1, 2012
PCA PUMP (AUZ)
FDA Adverse Event
Malfunction
·HOSPIRA, INC.·Product code MEA·June 2, 2010
OT VERIO IQ METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·May 14, 2013
PORTABLE OXYGEN GENERATOR (CONCENTRATOR, HOMEFILL)
FDA Adverse Event
Malfunction
·INVACARE FLORIDA OPERATIONS·Product code CAW·September 24, 2014
TRANSTAR STRETCHER
FDA Adverse Event
Malfunction
·HILL-ROM INC.·Product code FPO·May 25, 2011
INLIVEN CRT-P, Model Numbers: a) V284 b) V285 c) W274 d) W275 (added 7/15/2021)
FDA Enforcement
Class I
·Ongoing·Boston Scientific Corporation·July 21, 2021
Model Number L231, PROPONENT DR EL MRI Pacemaker
FDA Enforcement
Class I
·Ongoing·Boston Scientific Corporation·October 22, 2025