9 results
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22ms
·
Sources: EU EUDAMED, US FDA
Collagen Dura Regeneration Membrane - Repair
FDA 510(k)
FDA Class 2
·Neurology
DCL MICROALBUMIN ASSAY, MODEL 252-20
FDA 510(k)
FDA Class 2
·Immunology
OES ELITE Telescopes, Protective Tube
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
GORE® TAG® THORACIC ENDOPROSTHESIS
FDA Adverse Event
Injury
·W.L. GORE & ASSOCIATES·Product code MIH·November 14, 2014
OCTRODE LEAD KIT, 60CM LENGTH
FDA Adverse Event
Injury
·ST. JUDE MEDICAL - NEUROMODULATION·Product code LGW·September 12, 2011
LH 500 HEMATOLOGY ANALYZER
FDA Adverse Event
Malfunction
·BECKMAN COULTER·Product code GKZ·July 29, 2013
STEALTHSTATION¿ S8 SYSTEM
FDA Adverse Event
Malfunction
·MEDTRONIC NAVIGATION, INC.·Product code HAW·April 7, 2026
MultiDiagnost Eleva, System codes 722030 722016 722017 708032 708036 708034 708037 708038
FDA Enforcement
Class II
·Terminated·Philips North America, LLC·March 25, 2020
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