BEUDAMED
    7 results · 28ms · Sources: EU EUDAMED, US FDA

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    STATLAB A-350 SALIVA ALCOHOL TEST

    FDA 510(k)
    FDA Class 2 ·Clinical Toxicology

    PE.R.I. II KNEE FRACTURE SYSTEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    RINGLOC + HYBRID ACETABULAR SYSTEM

    FDA 510(k)
    FDA Class 3 ·Orthopedic

    VALIANT CAPTIVIA

    FDA Adverse Event
    Death ·MEDTRONIC IRELAND·Product code MIH·June 30, 2014

    MONARC SLING SYSTEM

    FDA Adverse Event
    Injury ·AMERICAN MEDICAL SYSTEMS, INC.·Product code FTL·January 2, 2013

    X8000 LIGHTSOURCE

    FDA Adverse Event
    Malfunction ·STRYKER ENDOSCOPY SAN JOSE·Product code FCW·November 12, 2010

    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