BEUDAMED
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    DUPONT ACA PLUS IMMUNOASSAY SYSTEM FOLLICLE STIMULATING HORMONE

    FDA 510(k)
    FDA Class 1 ·Clinical Chemistry

    LARES ULTRALITE PROSTYLE HIGH-SPEED DENTAL HANDPIECES, LARES EURO PROSTYLE HIGH-SPEED DENTAL HANDPIECES, LARES TURBO+ PR

    FDA 510(k)
    FDA Class 1 ·Dental

    ACCU-STAT HOME DRUG TEST CUP FOR MAIJUANNA (THC), COCAINE (COC), AMPHETAMINE (AMP), METHAMPHETAMINE (MAMP), ECSTASY

    FDA 510(k)
    FDA Class 2 ·Clinical Toxicology

    LUMBAR CATHETER OPEN TIP

    FDA Adverse Event
    Malfunction ·MEDTRONIC NEUROSURGERY·Product code JXG·January 18, 2013

    LEAD MODEL 300-20

    FDA Adverse Event
    Malfunction ·CYBERONICS, INC.·Product code LYJ·December 16, 2010

    LLC - PEEK 5 DEGREES MEDIUM SPACER - 10MM X 25MM X 8MM

    FDA Adverse Event
    Injury ·ALPHATEC SPINE INC·Product code MQP·July 17, 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