BEUDAMED
    8 results · 19ms · Sources: EU EUDAMED, US FDA

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    MoMe ARC® Wireless Ambulatory ECG Monitoring and Detection System (32000)

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    COMPRESSION ANASTOMOSIS RING (CAR)

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

    Healgen Multi-Drug Urine Test Cup, Healgen Multi-Drug Urine Test Dip Card

    FDA 510(k)
    FDA Class 2 ·Clinical Toxicology

    BELT CLIP

    FDA Adverse Event
    Malfunction ·MEDTRONIC MINIMED·Product code MDS·November 7, 2014

    COLLEAGUE

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·September 15, 2011

    VASOVIEW HEMOPRO 2

    FDA Adverse Event
    Malfunction ·MAQUET CARDIOVASCULAR, LLC·Product code GEI·July 24, 2013

    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

    Exactech Equinoxe REVERSE SHOULDER, 38mm Humeral Liner: a) +0mm, Item Number 320-38-00, b) +2.5mm, Item Number 320-38-03; Shoulder Arthroplasty

    FDA Enforcement
    Class II ·Ongoing·Exactech, Inc.·April 10, 2024