13 results · 28ms · Sources: EU EUDAMED, US FDA

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Longeviti ClearFit OTS Cranial Implant

FDA 510(k)
FDA Class 2 ·Neurology

Blade Handle

FDA UDI
KATENA PRODUCTS, INC.·00841668112373·CHUCK HANDLE #3KA 7.5CM LONG

OsteoMed

FDA UDI
OSTEOMED LLC·00845694022293·FPS 1.3mm Pilot for 2.0 Screw Drill Guide Compr...

ELMED

FDA UDI
ELMED INCORPORATED·00842180171596·Thin Glenoid Retractor Wide, Overall Length: 11...

CROSSPOINT TRANSACCESS CATHETER, MODEL TA-XP-001

FDA 510(k)
FDA Class 2 ·Radiology

STABILIZATION SCREW

FDA 510(k)
FDA Class 2 ·Orthopedic

OPTILITE® FREELITE® KAPPA FREE KIT

FDA Adverse Event
Injury ·THE BINDING SITE LIMITED·Product code DFH·March 30, 2026

OPTILITE® FREELITE® KAPPA FREE KIT

FDA Adverse Event
Injury ·THE BINDING SITE LIMITED·Product code DFH·March 31, 2026

ENTRUST

FDA Adverse Event
Injury ·MDT PUERTO RICO OPERATIONS CO, MED REL·Product code LWS·September 1, 2011

GDC-10 ULTRASOFT COIL

FDA Adverse Event
Injury ·NEUROVASCULAR DIVISION, BOSTON SCIENTIFIC CORPORATION·Product code HCG·November 13, 2008

BHR

FDA Adverse Event
Injury ·SMITH & NEPHEW ORTHOPAEDICS, LTD.·Product code NXT·July 17, 2013

INTELLIS

FDA Adverse Event
Malfunction ·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code LGW·August 22, 2023

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