8 results · 18ms · Sources: EU EUDAMED, US FDA

Get notified when this changes

We'll email you when new records match this search — new devices, new clearances, certificate changes, or withdrawals.

QUALITATIVE KERATOMETER M823 WITH POWER SUPPLY

FDA 510(k)
FDA Class 1 ·Ophthalmic

DeRoyal

FDA UDI
DEROYAL INDUSTRIES, INC.·00749756394123·PROCEDURE PACK

APEX KNEE SYSTEM, APEX ALL POLY TIBIA

FDA 510(k)
FDA Class 2 ·Orthopedic

Medical Face Mask

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

UNKNOWN NECK

FDA Adverse Event
Injury ·STRYKER ORTHOPAEDICS CORK·Product code MEH·January 4, 2013

ANNEURX STENT GRAFT WITH XCELERANT DELIVERY SYSTEM

FDA Adverse Event
Injury ·MEDTRONIC CARDIOVASCULAR·Product code MIH·November 24, 2010

RIATA ST ACTIVE FIXATION

FDA Adverse Event
Injury ·ST. JUDE MEDICAL, INC., CRMD·Product code NVY·July 2, 2014

Stryker T2 Arthrodesis Nailing System. Manufacturer: Stryker Trauma GmbH, Professor-Kuntscher-Str. 1-5, 24232 Schonkirchen Germany. Distributed in the USA by Stryker Orthopaedics, 325 Corporate Drive, Mahwah, NJ 07430. The T2 Arthrodesis Nail is intended for the treatment of Knee Arthrodesis. The design of the T2 Arthrodesis Nail features a unique curvature which incorporates both femur ante curvature and knee valgus bend. Indications: Aseptic failed total knee arthro-plasty with or without bone loss; Failed external fixation, non unions and malunions; Periarticular fractures where repair is not possible; Pathologic fractures and tumor resections; Pseudoarthrosis and correct osteotomy; Ipsilateral femur fractures; and Open and closed femoral fractures.

FDA Enforcement
Class II ·Terminated·Stryker Howmedica Osteonics Corp.·July 25, 2012