9 results
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17ms
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Sources: EU EUDAMED, US FDA
MICROSURGICAL SCISSORS
FDA 510(k)
FDA Class 1
·Orthopedic
Epicage Interbody Fusion System
FDA UDI
ALPHATEC SPINE, INC.·00840967190716·Midline Portal – 12mm
FORZA
FDA UDI
Orthofix US LLC·18257200077182·9W X 27L X 0° X 12H STRAIGHT TRIAL
AXS Vecta Aspiration System
FDA 510(k)
FDA Class 2
·Cardiovascular
MAC 800 RESTING ECG ANALYSIS SYSTEM
FDA 510(k)
FDA Class 2
·Cardiovascular
REALIZE ADJ GASTRIC BAND-C
FDA Adverse Event
Malfunction
·OBTECH MEDICAL SARL_·Product code LTI·November 3, 2010
CURRENT RF VR
FDA Adverse Event
Injury
·ST. JUDE MEDICAL INC., CRMD·Product code LWS·January 13, 2014
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