BEUDAMED
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    BIOGEL SENSOR SURGEON'S GLOVE WITH NON-PYROGENIC STATEMENT

    FDA 510(k)
    FDA Class 1 ·General, Plastic Surgery

    KMEDIC

    FDA UDI
    TELEFLEX INCORPORATED·24026704293937·

    Key Surgical K-Wires and Steinmann Pins

    FDA UDI
    KEY SURGICAL, INC.·00849771015154·Steinmann Pins, Single diamond, threaded, 5/64-...

    NA

    FDA UDI
    KEY SURGICAL, INC.·10849771050008·Steinmann Pins, Single diamond, threaded, 5/64-...

    Vilex Power Accessory

    FDA UDI
    VILEX IN TENNESSEE, INC.·00841731122155·KWire .028x4" (0.7x100mm)

    JOBST Elvarex

    FDA UDI
    BSN-Jobst GmbH·04019702366525·Elvarex 3/Knee High/Open Toe/Dotted silicone ba...

    JOBST Elvarex

    FDA UDI
    BSN-Jobst GmbH·04019702382853·ELVAREX 2/MID THIGH HIGH/SLANT, OPEN TOE, E-VER...

    JOBST Elvarex

    FDA UDI
    BSN-Jobst GmbH·04019702542714·Elvarex Forte 3/Knee High/Profile-Slant-Open To...

    MODULITH SLK LITHOTRIPTER

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

    XPLAN 2.1

    FDA 510(k)
    FDA Class 2 ·Radiology

    DEPUY ASR XL FEM IMP SIZE 43

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

    LAHEY SCS 5-3/4 CVD

    FDA Adverse Event
    Malfunction ·J. JAMNER SURGICAL INSTRUMENTS·Product code LRW·February 22, 2011

    QUANTUM MAVERICK MR BALLOON CATHETER

    FDA Adverse Event
    Malfunction ·BOSTON SCIENTIFIC CORPROATION·Product code LOX·July 9, 2008

    Equinoxe Reverse Shoulder Compression Screw/Locking Cap Kit 4.5 x 22 mm.

    FDA Enforcement
    Class II ·Terminated·Exactech, Inc.·October 7, 2020

    Stryker MA204 Bed Model (FL25E) Beds are intended for medical purposes in both general patient care as well as critical care environments. Each uses built-in electric motors and controls which can be operated by the patient, or caregiver, to adjust the height and/or surface contour of the bed.The devices listed above also include movable and latchable side rails which can be lowered or raised to help prevent patient fall and subsequent injury. The Beds include an optional Scale (Models: FL20E, FL25E, FL28C, FL28EX) as well as an optional Bed Exit (1 Zone) or Chaperone

    FDA Enforcement
    Class II ·Terminated·Stryker Medical Division of Stryker Corporation·July 4, 2012

    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