10 results
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27ms
·
Sources: EU EUDAMED, US FDA
DISPOSABLE ANGIOGRAPHY NEEDLES
FDA 510(k)
FDA Class 2
·Cardiovascular
Durasphere ®
FDA UDI
Carbon Medical Technologies, Inc.·00858015005622·Injection Needle, Pencil Point
FORZA
FDA UDI
Orthofix US LLC·18257200077151·9W X 27L X 0° X 9H STRAIGHT TRIAL
INTER FIX™ Threaded Fusion Device
FDA UDI
MEDTRONIC SOFAMOR DANEK, INC.·00673978072319·20X29MM INTER FIX THREADED
HEMOSIL LIQUID HEPARIN, HEPARIN CALIBRATORS AND LMW AND UF HEPARIN CONTROLS
FDA 510(k)
FDA Class 2
·Hematology
FILTER SYSTEM, ALTNER DISPOSABLE
FDA 510(k)
FDA Class 2
·General Hospital
RESTORE ULTRA
FDA Adverse Event
Malfunction
·MDT PUERTO RICO OPERATIONS CO., JUNCOS·Product code LGW·October 22, 2010
ATLAS DR
FDA Adverse Event
Injury
·ST. JUDE MEDICAL INC., CRMD·Product code LWS·January 13, 2014
RIATA ACTIVE FIXATION
FDA Adverse Event
Malfunction
·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code NVY·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