BEUDAMED
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    DIACLEAR ULTRAFILTER

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

    N/A

    FDA UDI
    MEDTRONIC SOFAMOR DANEK, INC.·00643169328747·TEMPLATE 3003957 ZEVO 57MM 3 LVL

    Leksell Stereotactic System

    FDA UDI
    Elekta Instrument AB·07340048302548·POST INSULATED POSTERIOR

    MINMED QUICK SET

    FDA Adverse Event
    Injury ·UNOMEDICAL A/S·Product code FPA·July 11, 2024

    MODULAR ROTATING HINGE KNEE TIBIAL ROTATING COMPONENT

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    HOFFMANN II EXTERNAL FIXATION SYSTEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    HEYER-SCHULTE LOW PROFILE GEL-FILLED MAMMARY PROSTHESIS

    FDA Adverse Event
    V. MUELLER DIV. BAXTER HEALTHCARE CORP.·Product code FTR·November 8, 1994

    MINIMED QUICK-SET

    FDA Adverse Event
    Malfunction ·UNOMEDICAL A/S·Product code FPA·November 29, 2024

    MINIMED QUICK-SET

    FDA Adverse Event
    Malfunction ·UNOMEDICAL DEVICES S.A. DE C.V.·Product code FPA·June 19, 2025

    OBTRYX SYSTEM

    FDA Adverse Event
    Injury ·BOSTON SCIENTIFIC - MARLBOROUGH·Product code FTL·March 14, 2013

    FG 6301 DUAL CHNL VOL INF PUMP2M8064 SERVICE

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·March 1, 2011

    SILICONE BREAST IMPLANTS - LEFT

    FDA Adverse Event
    Injury ·MCGHAN MEDICAL, INAMED AESTHETICS·Product code FTR·February 26, 2008

    ARCHITECT HE4 REAGENT KIT

    FDA Adverse Event
    Malfunction ·ABBOTT GMBH·Product code OIU·February 6, 2026

    bk3000 Ultrasound System w/battery; Model No. 2300-66; System, Imaging, Pulsed Doppler, Ultrasonic

    FDA Enforcement
    Class II ·Ongoing·B-K Medical A/S·November 12, 2025

    CADD-Solis Ambulatory Infusion Pumps, Model 2100. Intended for the following uses: 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