14 results
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20ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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VARIOGUIDE DRILL KIT
FDA 510(k)
FDA Class 2
·Neurology
AGXO
FDA UDI
Oticon A/S·05707131257581·H150, BTE 13 WL 85 SGR AGXO
Aileron Posterior Fusion System
FDA UDI
Life Spine, Inc.·00190837000561·
Aileron Posterior Fusion System
FDA UDI
Life Spine, Inc.·00190837000578·
DURAMAX .018 BILIARY STENT SYSTEM
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
NOBEL ACTIVE 3.0
FDA 510(k)
FDA Class 2
·Dental
INFUSE BONE GRAFT
FDA Adverse Event
Injury
·MEDTRONIC SOFAMOR DANEK USA, INC·Product code NEK·May 29, 2013
TRANSTAR STRETCHER
FDA Adverse Event
Malfunction
·HILL-ROM, INC.·Product code FPO·June 14, 2011
HEMOGLIDE KIT
FDA Adverse Event
Malfunction
·C. R. BARD INC. (BASD)·Product code MSD·August 22, 2008
TRULIANT TIB IMP PSC INSERT SZ 3.5, 19MM
FDA Adverse Event
Injury
·EXACTECH, INC.·Product code JWH·May 14, 2024
BD EMERALD¿ 10ML SYRINGE
FDA Adverse Event
Malfunction
·BECTON DICKINSON, S.A.·Product code FMF·September 15, 2017
THERMAGE CPT SYSTEM
FDA Adverse Event
Injury
·SOLTA MEDICAL, INC·Product code GEI·November 12, 2020
THERMAGE CPT SYSTEM TIP
FDA Adverse Event
Injury
·SOLTA MEDICAL INC·Product code GEI·November 30, 2022
Brand Name: Optisite Arterial Cannula Product Name: Optisite Arterial Cannula Model/Catalog Number: OPTI16 Software Version: N/A Product Description: Cardiac cannula. The Edwards OptiSite Arterial Perfusion Cannluae provides or establishes arterial perfusion in the extracorporeal circuit for d 6 hours. Component: No.
FDA Enforcement
Class I
·Ongoing·Edwards Lifesciences, LLC·July 16, 2025