8 results
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26ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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MOSS MIAMI 6.35MM POLYAXIAL SCREW
FDA 510(k)
FDA Class 2
·Orthopedic
De Soutter Medical
FDA UDI
DE SOUTTER MEDICAL LIMITED·05051471123830·K-WIRE - DOUBLE TROCAR 1.6mm DIA x 200mm
ELECSYS HCG+B CALCHECK 5
FDA 510(k)
FDA Class 1
·Clinical Chemistry
Idys ALIF ZP 3DTi
FDA 510(k)
FDA Class 2
·Orthopedic
PINNACLE MTL INS NEUT36IDX54OD
FDA Adverse Event
Injury
·DEPUY INTL., LTD. ¿ REG. # 8010379·Product code KWA·March 7, 2013
ATTAIN ABILITY
FDA Adverse Event
Injury
·MEDTRONIC PUERTO RICO, INC.·Product code OJX·February 15, 2011
EVERA XT DR
FDA Adverse Event
Injury
·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code LWS·August 8, 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