22 results
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22ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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TELESCOPING PENEVAC
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
ARTRAC VITAL SIGNS MON. MODELS 7000 AND 5000 & ACC
FDA 510(k)
FDA Class 2
·Cardiovascular
UNITEK LIFT-OFF DEBRACKETING INSTRUMENT
FDA 510(k)
FDA Class 1
·Dental
PORTEX® BIVONA® NEONATAL AND PEDIATRIC TTS¿ TRACHEOSTOMY TUBES
FDA Adverse Event
Death
·SMITHS MEDICAL ASD INC.·Product code JOH·September 19, 2016
ROHS MICROSENSOR W/SINGLE LUMEN METAL BOLT KIT
FDA Adverse Event
Malfunction
·CODMAN & SHURTLEFF, INC.·Product code GWM·January 31, 2017
ROHS MICROSENSOR W/SINGLE LUMEN METAL BOLT KIT
FDA Adverse Event
Malfunction
·CODMAN & SHURTLEFF, INC.·Product code GWM·January 31, 2017
BIVONA® CUSTOM NEONATAL AND PEDIATRIC TRACHEOSTOMY TUBES
FDA Adverse Event
Injury
·SMITHS MEDICAL ASD INC.·Product code JOH·August 15, 2016
PORTEX® BIVONA® NEONATAL AND PEDIATRIC TTS¿ (TIGHT-TO-SHAFT) TRACHEOSTOMY TUBES
FDA Adverse Event
Injury
·SMITHS MEDICAL ASD, INC.·Product code JOH·April 12, 2017
ROHS MICROSENSOR W/SINGLE LUMEN METAL BOLT KIT
FDA Adverse Event
Malfunction
·CODMAN & SHURTLEFF, INC.·Product code GWM·December 16, 2016
PORTEX® BIVONA® NEONATAL AND PEDIATRIC TTS¿ (TIGHT-TO-SHAFT) TRACHEOSTOMY TUBES
FDA Adverse Event
Malfunction
·SMITHS MEDICAL ASD INC.,·Product code JOH·July 16, 2016
ROHS MICROSENSOR W/SINGLE LUMEN METAL BOLT KIT - 10886704075486
FDA Adverse Event
Injury
·CODMAN & SHURTLEFF, INC.·Product code GWM·April 20, 2016
ROHS MICROSENSOR W/SINGLE LUMEN METAL BOLT KIT - 10886704075486
FDA Adverse Event
Injury
·CODMAN & SHURTLEFF, INC.·Product code GWM·April 20, 2016
HF-RESECTION ELECTRODE, LOOP, 24 FR., 0.35 WIRE, 12, STERILE
FDA Adverse Event
Malfunction
·OLYMPUS WINTER & IBE GMBH·Product code GCP·August 11, 2021
BIVONA® CUSTOM NEONATAL AND PEDIATRIC TRACHEOSTOMY TUBES
FDA Adverse Event
Injury
·SMITHS MEDICAL ASD INC.·Product code JOH·August 15, 2016
BIVONA PEDIATRIC TTS TRACHEOSTOMY TUBE
FDA Adverse Event
Malfunction
·SMITHS MEDICAL ASD, INC.·Product code JOH·April 27, 2017
STARCLOSE VASCULAR CLOSURE SYSTEM
FDA Adverse Event
Malfunction
·ABBOTT VASCULAR INC.·Product code MGB·April 23, 2007
TOTALCARE
FDA Adverse Event
Malfunction
·HILL-ROM, INC.·Product code FNL·December 16, 2010
THERMOCOOL® SMARTTOUCH® BI-DIRECTIONAL NAVIGATION CATHETER
FDA Adverse Event
Malfunction
·BIOSENSE WEBSTER, INC (IRWINDALE)·Product code LPB·July 23, 2014
HF-RESECTION ELECTRODE
FDA Adverse Event
Malfunction
·OLYMPUS WINTER & IBE GMBH·Product code GCP·March 8, 2023
HF-RESECTION ELECTRODE
FDA Adverse Event
Malfunction
·OLYMPUS WINTER & IBE GMBH·Product code GCP·March 8, 2023