10 results
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26ms
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Sources: EU EUDAMED, US FDA
HANDLING & CUTTING DEVICE FOR IRIDIUM-192 WIRE PIN
FDA 510(k)
FDA Class 1
·Radiology
APEX Knee System
FDA UDI
Omni Life Science, Inc.·00841690189466·Apex Revision Knee System - Revision Tibia Inst...
APEX Knee System
FDA UDI
Omni Life Science, Inc.·00841690189459·Apex Revision Knee System - Revision Tibia Inst...
VISA-GRIP
FDA 510(k)
FDA Class 1
·Physical Medicine
HANDYLAB GBS ASSAY, HANDYLAB JAGUAR INSTRUMENT, HANDYLAB DNA EXTRACTION STRIP, HANDYLAB E3 EXTRACTION REAGENT, HANDYLAB
FDA 510(k)
FDA Class 1
·Microbiology
LOGIC TIBIA PS MOD INSRT SZ 3 9MM
FDA Adverse Event
Injury
·EXACTECH, INC.·Product code JWH·July 13, 2023
CAREFUSION
FDA Adverse Event
Injury
·CAREFUSION·Product code FRN·May 21, 2014
IINTERSTIM II
FDA Adverse Event
Malfunction
·MDT PUERTO RICO OPERATIONS CO., JUNCOS·Product code EZW·October 22, 2010
OT PING METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·December 28, 2012
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