9 results
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27ms
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Sources: EU EUDAMED, US FDA
HCG, INC. MEDICAL LASER ENDOCOAGULATOR MODEL P.C.
FDA 510(k)
FDA Class 2
·Ophthalmic
NAR Kit
FDA UDI
NORTH AMERICAN RESCUE, LLC·00842209109203·KIT, RIG EAGLE - COY - CUSTOM
ORAcollect.Dx
FDA 510(k)
FDA Class 2
·Clinical Chemistry
TINA-QUANT HEMOGLOBIN A1C GEN.2 TEST
FDA 510(k)
FDA Class 2
·Hematology
COREVALVE 26MM AORTIC VALVE
FDA Adverse Event
Injury
·MEDTRONIC HEART VALVES DIVISION·Product code NPT·June 5, 2014
9900
FDA Adverse Event
Malfunction
·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·November 13, 2012
MALLINCKRODT
FDA Adverse Event
Injury
·COVIDIEN, FORMERLY TYCO HEALTHCARE·Product code BTR·September 29, 2010
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
Zimmer, Cuff Tourniquet Dual Hose Single Bladder Maroon Reprocessed by Sterilmed, Sterile EO, Rx only.
FDA Enforcement
Class II
·Terminated·STERILMED, INC.·December 16, 2015