BEUDAMED
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    BIODRIVE MICRO SCREW SYSTEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    BDRV CANN SCW SS P/T DIA4.5X60MM

    FDA Adverse Event
    Injury ·BIOMET SPAIN, S.L.·Product code HRS·January 26, 2017

    BDRV CANN SCW SS P/T DIA4.5X52MM

    FDA Adverse Event
    Injury ·BIOMET SPAIN, S.L.·Product code HRS·January 26, 2017

    EZ-TRAVELER 3000 SERIES MANUAL WHEELCHAIR

    FDA 510(k)
    FDA Class 1 ·Physical Medicine

    BOSS 2000-3 VACUUM ERECTION DEVICE

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

    GE HEALTHCARE CARESCAPE Central Station (CSCS) software version 2.0.2 The CARESCAPE Central Station is intended to collect information from a network and display this data. This data includes physiological, patient demographic and/or other non-medical information. Physiological parameters and waveforms from monitors and telemetry systems can be displayed, provide alarm annunciation, and can be printed from the CARESCAPE Central Station.

    FDA Enforcement
    Class II ·Terminated·GE Medical Systems Information Technologies, Inc.·February 7, 2018

    TIP COVER ACCESSORY

    FDA Adverse Event
    Malfunction ·INTUITIVE SURGICAL,INC.·Product code NAY·May 3, 2013

    ACTIVA

    FDA Adverse Event
    Malfunction ·NEURO - VILLALBA·Product code MHY·September 16, 2014

    PENTA 3MM LEAD, 60 CM

    FDA Adverse Event
    Injury ·ST JUDE MEDICAL - NEUROMODULATION·Product code LGW·May 10, 2011

    Stryker Oasys Midline Occiput Plate-1) Small 2) Medium 3) Large 4) Large Long 5) Mini. Allows for positioning directly on the midline keel of the occiput.

    FDA Enforcement
    Class I ·Terminated·Stryker Spine·August 28, 2013

    UNKNOWN

    FDA Adverse Event
    Injury ·MEDTRONIC SOFAMOR DANEK USA, INC.·Product code OWI·April 24, 2026

    UNKNOWN

    FDA Adverse Event
    Injury ·MEDTRONIC SOFAMOR DANEK USA, INC.·Product code MNI·April 24, 2026

    M2A-MAGNUM PF CUP 56ODX50ID

    FDA Adverse Event
    Injury ·BIOMET ORTHOPEDICS·Product code LPH·August 23, 2017

    Exactech Equinoxe REVERSE SHOULDER, 38mm Humeral Liner: a) +0mm, Item Number 320-38-00, b) +2.5mm, Item Number 320-38-03; Shoulder Arthroplasty

    FDA Enforcement
    Class II ·Ongoing·Exactech, Inc.·April 10, 2024