8 results
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36ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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See Factor CT3
FDA 510(k)
FDA Class 2
·Radiology
INQWIRE DIAGNOSTIC GUIDE WIRE
FDA 510(k)
FDA Class 2
·Cardiovascular
TRACERS TA BONE CEMENT OPACIFIER, MODEL TCR-TA
FDA 510(k)
FDA Class 2
·Neurology
COMPREHENSIVE SHOULDER SYSTEM MODULAR HEAD - VARIABLE OFFSET
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code MBF·February 6, 2024
IVT DISPOSABLE
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - AIBONITO·Product code KPE·November 6, 2014
*
FDA Adverse Event
CONMED CORPORATION·Product code GEI·August 29, 2011
OT VERIO IQ METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·July 18, 2013
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