13 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: 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