BEUDAMED
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    AI-Rad Companion Organs RT

    FDA 510(k)
    FDA Class 2 ·Radiology

    CoRoent

    FDA UDI
    Nuvasive, Inc.·00887517629753·CoRoent Ant TLIF Ti, 12x11x30mm 15°

    Luna

    FDA UDI
    ULTRADENT PRODUCTS, INC.·00883205004246·Luna Opal R Mini .022 UL3 (0°T +11°A)

    n.a.

    FDA UDI
    Karl Storz GmbH & Co. KG·04048551074466·Ear Forceps, curved left, 8 cm

    T:SLIM X2 INSULIN PUMP WITH CONTROL-IQ TECHNOLOGY

    FDA Adverse Event
    Malfunction ·TANDEM DIABETES CARE·Product code QFG·September 22, 2021

    STERLING MEDICAL IMPULSE 3 STIMULATOR

    FDA 510(k)
    FDA Class 2 ·Neurology

    MICROLIFE WRIST WATCH BLOOD PRESSURE, MODEL BP-3BU1-5, WITH OPTIONAL THERMAL PRINTER

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    MENTOR(R) WET-FIELD(R) II AC COAGULATOR, 22-1305

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

    EGIA 60 ARTICULATING MED/THICK SULU

    FDA Adverse Event
    Injury ·UNITED STATES SURGICAL·Product code GDW·August 17, 2011

    PROLENE POLYPROPYLENE SUTURE

    FDA Adverse Event
    Injury ·ETHICON INC.·Product code GAW·November 3, 2014

    OBTRYX SYSTEM

    FDA Adverse Event
    Injury ·BOSTON SCIENTIFIC - MARLBOROUGH·Product code FTL·July 11, 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