13 results · 21ms · Sources: EU EUDAMED, US FDA

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Astroid Planning App

FDA 510(k)
FDA Class 2 ·Radiology

Sklar®

FDA UDI
SKLAR CORPORATION·10649111389184·WEISS TUBE OCCLUD FCP 5 3/4"

Cook

FDA UDI
COOK INCORPORATED·00827002165991·Topel Endoscopic Cyst Aspiration Needle

DEMEQUICKTM (RAPID ABSORBABLE) SYNTHETIC SURGICAL SUTURE

FDA 510(k)
FDA Class 2 ·General, Plastic Surgery

OXFORD FIXED LATERAL BEARING PARTIAL KNEE REPLACEMENT (BEARINGS / TRAYS)

FDA 510(k)
FDA Class 2 ·Orthopedic

QUATTRODE LEAD, 3/6MM, 60 CM

FDA Adverse Event
Injury ·ABBOTT MEDICAL·Product code LGW·November 19, 2025

QUATTRODE LEAD, 3/6MM, 60 CM

FDA Adverse Event
Injury ·ABBOTT MEDICAL·Product code LGW·November 19, 2025

QUATTRODE LEAD, 3/6MM, 60 CM

FDA Adverse Event
Injury ·ABBOTT MEDICAL·Product code LGW·November 19, 2025

DURATA STS OPTIM ACTIVE FIXATION, DF-4 CONNECTOR

FDA Adverse Event
Injury ·ST. JUDE MEDICAL, INC., CRMD·Product code NVY·October 15, 2014

SHORTCUT F/MATMAND-PL T1.5-2.8 W/RASP IN

FDA Adverse Event
Malfunction ·SYNTHES GMBH·Product code HTZ·June 17, 2013

COLLEAGUE PRE P1.7

FDA Adverse Event
Malfunction ·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·July 24, 2011

HEARTMATE 3 LVAS IMPLANT KIT

FDA Adverse Event
Injury ·THORATEC CORPORATION·Product code DSQ·December 22, 2022

various polyethylene implants Knees Revision Tibial Tray Systems Oxford Partial Knee Orthopedic Salvage System Vanguard Complete Knee System Vanguard SSK Revision System Biomet Patella Maxim Complete Knee System Biomet Series A Patella Vanguard 360 Revision System Vanguard Deep Dish Rotating Platform Biomet CP Bearings Product Usage: For use in total knee arthroplasty. Limb salvage joint reconstruction. Partial knee replacement.

FDA Enforcement
Class II ·Terminated·Zimmer Biomet, Inc.·April 26, 2017