BEUDAMED
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    PF Nitrile Exam Glove with pH coating, Black-Gray Color, Tested for Use with Chemo Drugs

    FDA 510(k)
    FDA Class 1 ·General Hospital

    CLICKFIT TRANSFER GUIDE TUBES NEEDLE CLICKFIT TRANSFER GUIDE TUBES CATHETER TRANSFER GUIDE TUBE SET VARISOURCE LUER TRAN

    FDA 510(k)
    FDA Class 2 ·Radiology

    XPERT FLU, GENEXPERT DX SYSTEMS, GENEXPERT INFINITY SYSTEM, GENEXPERT SYSTEM SOFTWARE VERISIONS 2.1 AND 4.0

    FDA 510(k)
    FDA Class 2 ·Microbiology

    DEXCOM G6 CONTINUOUS GLUCOSE MONITORING SYSTEM

    FDA Adverse Event
    Malfunction ·DEXCOM, INC.·Product code QBJ·July 20, 2024

    ALTRUA

    FDA Adverse Event
    Malfunction ·GUIDANT CRM CLONMEL IRELAND·Product code NVZ·July 24, 2011

    OT VERIO IQ METER

    FDA Adverse Event
    Malfunction ·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·June 17, 2013

    OPTICROSS?

    FDA Adverse Event
    Malfunction ·BOSTON SCIENTIFIC - FREMONT (SUD)·Product code OBJ·October 15, 2014

    Medtronic MiniMed(TM) Quick-set(TM) (MMT-394, 394T, 399, 399T, 387, 387T, 398, 398T, 397, 397T, 386, 386T, 396, 396T)

    FDA Enforcement
    Class II ·Ongoing·Medtronic Inc.·November 29, 2017

    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