8 results
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19ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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DEPUY GLOBAL SHOULDER GLENOID
FDA 510(k)
FDA Class 2
·Orthopedic
Polystar Selection EDITION
FDA UDI
Merz Dental GmbH·D7091981487·anteriors; shade BL3; mould CM2
OPHTHALMIC CANNULA
FDA 510(k)
FDA Class 1
·Ophthalmic
EARLY PREGNANCY DETECTION KIT
FDA 510(k)
FDA Class 2
·Clinical Chemistry
ACCESS
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - CALI·Product code FPA·February 27, 2013
LIGASURE IMPACT
FDA Adverse Event
Malfunction
·COVIDIEN VALLEYLAB·Product code GEI·January 25, 2011
VICRYL (POLYGLACTIN 910) SUTURE
FDA Adverse Event
Injury
·ETHICON INC.·Product code GAM·August 5, 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