14 results · 20ms · Sources: EU EUDAMED, 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