BEUDAMED
    8 results · 19ms · Sources: EU EUDAMED, US FDA

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    POWERHEART CARDIAC RHYTHM MODULE

    FDA 510(k)
    FDA Class 3 ·Cardiovascular

    CARTOUCH

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    EXEL SECURE TOUCH SAFETY (P.S.V.) SCALP VEIN SET

    FDA 510(k)
    FDA Class 2 ·General Hospital

    FREESTYLE

    FDA Adverse Event
    Malfunction ·ABBOTT DIABETES CARE INC.·Product code LFR·May 16, 2007

    OCTRODE

    FDA Adverse Event
    Injury ·ST. JUDE MEDICAL - NEUROMODULATION·Product code LGW·March 13, 2013

    YAG/KTP LASER

    FDA Adverse Event
    Malfunction ·Product code GEX·March 3, 2011

    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

    Exactech Equinoxe REVERSE SHOULDER,42mm Humeral Liner, a) +0mm, Item number 320-42-00, b) +2.5mm, Item Number 320-42-03; Shoulder Arthroplasty

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