BEUDAMED
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    MODIFICATON TO: GIVEN DIAGNOSTIC IMAGING SYSTEM

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology

    Tiche PTA Balloon Dilatation Catheter

    FDA UDI
    BrosMed Medical Co.,Ltd.·06958481476439·

    D/C CORE MATERIAL

    FDA 510(k)
    FDA Class 2 ·Dental

    BRACHYSEED

    FDA 510(k)
    FDA Class 2 ·Radiology

    LINEAR ST

    FDA Adverse Event
    Injury ·BOSTON SCIENTIFIC NEUROMODULATION·Product code LGW·April 17, 2021

    SPECTRA WAVEWRITER?

    FDA Adverse Event
    Injury ·BOSTON SCIENTIFIC NEUROMODULATION CORPORATION·Product code LGW·September 30, 2025

    NV GXL LINR, NTRL, 32MM ID, GROUP 2 CUPS

    FDA Adverse Event
    Injury ·EXACTECH, INC.·Product code MEH·July 20, 2022

    NV GXL LNR, LIPPED, 36MM ID, GROUP 3 CUPS

    FDA Adverse Event
    Injury ·EXACTECH, INC.·Product code JDI·July 9, 2024

    ASR UNI FEMORAL IMPL SIZE 43

    FDA Adverse Event
    Injury ·DEPUY INTERNATIONAL·Product code KWA·April 22, 2013

    ORTHO PROVUE

    FDA Adverse Event
    Malfunction ·MICROTYPING SYSTEMS·Product code KSZ·April 27, 2011

    WALLSTENT BILIARY ENDOPROSTHESIS

    FDA Adverse Event
    Malfunction ·BOSTON SCIENTIFIC·Product code FGE·July 7, 2008

    NV GXL LINR, NTRL, 28MM ID, GROUP 1 CUPS

    FDA Adverse Event
    Injury ·EXACTECH, INC.·Product code JDI·October 11, 2024

    NV GXL LINR, NTRL, 36MM ID, GROUP 3 CUPS

    FDA Adverse Event
    Injury ·EXACTECH, INC.·Product code JDI·October 28, 2024

    CADD-Solis VIP ambulatory Infusion Pumps, Model 2120 (21-2120, 21-2125, and 21-2127) Indicated for the following uses: Intra-arterial, subcutaneous, intraperitoneal, in close proximity to nerves, into an intraoperative site, epidural space or subarachnoid space. Therapies that require a continuous rate of infusion, intermittent bolus, and/or with patient-controlled demand doses.

    FDA Enforcement
    Class I ·Ongoing·Smiths Medical ASD Inc.·August 14, 2024

    Reprocessed Pressure Tourniquet Cuff (PTC) Tourniquet cuffs are single- or dual-bladder inflatable cuffs connected to a tourniquet system via a hose assembly. When wrapped around a limb and inflated, tourniquet cuffs apply an adequate amount of pressure on the arterial blood flow in a limb to create a bloodless surgical field. Tourniquet cuffs are available in a variety of sizes to accommodate a wide range of limb circumferences.

    FDA Enforcement
    Class II ·Terminated·Stryker Sustainability Solutions·November 9, 2016