BEUDAMED
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    CENTURION MOGEN CLAMP/CIRCUMCISION (STER/NON STER)

    FDA 510(k)
    FDA Class 2 ·Obstetrics/Gynecology

    MICROLINE SCREEN FOR OPIATES

    FDA 510(k)
    FDA Class 2 ·Clinical Toxicology

    CURELLE

    FDA 510(k)
    FDA Class 2 ·Obstetrics/Gynecology

    PEDICLE PROBE, LENKE CURVED (STAINLESS STEEL)

    FDA Adverse Event
    Injury ·ALPHATEC SPINE INC·Product code LXH·January 30, 2013

    ANIMAS INSULIN INFUSION PUMP

    FDA Adverse Event
    Malfunction ·Product code LZG·December 14, 2010

    FENESTRATED BIPOLAR FORCEPS INSTRUMENT

    FDA Adverse Event
    Malfunction ·INTUITIVE SURGICAL,INC.·Product code NAY·July 15, 2014

    Philips Allura Xper Systems (R7.6-R8.1). Labeled as the following: 1. Allura Xper FD10, Model Number: 722010. 2. Allura Xper FD10/10, Model Number: 722011. 3. Allura Xper FD20, Model Number: 722012. 4. Allura Xper FD20 Biplane, Model Number: 722013. 5. Allura Xper FD10 OR Table, Model Number: 722022. 6. Allura Xper FD20 OR Table, Model Number: 722023. 7. Allura Xper FD20 Biplane OR Table, Model Number: 722025.

    FDA Enforcement
    Class II ·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·December 18, 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