BEUDAMED
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    3.2MM UNIPOLAR & BIPOLAR LEAD CONNECTORS (VS-1)

    FDA 510(k)
    FDA Class 3 ·Cardiovascular

    RX PERMANENT PACING LEAD

    FDA Adverse Event
    Injury ·OSCOR INC.·Product code DTB·November 19, 2021

    QMS LAMOTRIGINE ASSAY (REAGENTS), CALIBRATORS & CONTROLS

    FDA 510(k)
    FDA Class 2 ·Clinical Toxicology

    TxRx Knee 15 Flare MR Coil 1.5T

    FDA 510(k)
    FDA Class 2 ·Radiology

    PLUM A+ DRIVER ED 2

    FDA Adverse Event
    Malfunction ·HOSPIRA COSTA RICA LTD.·Product code FRN·February 20, 2014

    ADAPTA DR

    FDA Adverse Event
    Malfunction ·MEDTRONIC MED REL, INC.·Product code NVZ·October 9, 2010

    OT ULTRALINK METER

    FDA Adverse Event
    Malfunction ·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·December 10, 2012

    XERF EFFECTOR 60. Electrosurgical unit.

    FDA Recall
    Open, Classified ·Lutronic Corporation 219 Sowon-Ro; Deogyang Goyang Korea (the Republic of)·Product code GEI·September 4, 2025

    ellman A CYNOSURE COMPANY Minor Surgery Bipolar Cable, Contents: Five (5) Disposable Bipolar Cables,STERILE The Minor Surgery Bipolar Cable is an accessory that is used to connect the bipolar handpieces to the RF generator for electrosurgical procedures that require the bipolar waveform.

    FDA Recall
    Terminated ·Ellman International, Inc.·Product code GEI·September 7, 2016

    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