13 results
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28ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: 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