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

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    840 VENTILATOR SYSTEM WITH EXPANDED NEOMODE OPTION

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    EXCISOR BIOPTOME, MODEL 01-0004

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

    INTRODUCER WITH DISTAL RADIOPAQUE MARKER BAND, MODEL OR-4926XX

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    MECHANICAL (MANUAL) WHEELCHAIR

    FDA Adverse Event
    Malfunction ·INVACARE TAYLOR STREET·Product code IOR·May 3, 2013

    GORE VIABAHN® ENDOPROSTHESIS

    FDA Adverse Event
    Injury ·W.L. GORE & ASSOCIATES·Product code NIP·September 16, 2014

    QUATTRODE PERCUTANEOUS LEAD

    FDA Adverse Event
    Injury ·ST. JUDE MEDICAL- NEUROMODULATION·Product code LGW·May 11, 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

    Alaris Syringe Pump, Model No. 8110. Delivers fluids. Expansion of Affected Units: BOM Housing Assembly Service, Part No. 49000226, and Lower Housing/Carriage Block Assembly, Part No. 148188-100.

    FDA Enforcement
    Class I ·Terminated·CareFusion 303, Inc.·August 26, 2015