BEUDAMED
    13 results · 33ms · Sources: EU EUDAMED, US FDA

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    VELA VENTILATOR

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    VELA VENTILATOR

    FDA Adverse Event
    Malfunction ·CAREFUSION·Product code CBK·July 21, 2015

    VELA VENTILATOR

    FDA Adverse Event
    Malfunction ·CAREFUSION·Product code CBK·February 19, 2015

    LEONE SPA

    FDA UDI
    LEONE SPA·08033707065807·EXTRAORAL ELASTIC KIT

    LEONE SPA

    FDA UDI
    LEONE SPA·08033707001287·THREE DIRECT SCREW 3 ANAT INOX 16mm

    FASTPACK PSA IMMUNOASSAY, FASTPACK ANALYZER

    FDA 510(k)
    FDA Class 2 ·Immunology

    ORTHOSONIX ENERGEX

    FDA 510(k)
    FDA Class 2 ·Physical Medicine

    OT VERIO IQ METER

    FDA Adverse Event
    Malfunction ·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·May 3, 2013

    HEARTSTART XL

    FDA Adverse Event
    Malfunction ·PHILIPS MEDICAL SYSTEMS·Product code MKJ·September 10, 2014

    9900

    FDA Adverse Event
    Malfunction ·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·May 3, 2011

    Instrument Kit for use with OsteoSponge SC grafts. The Instrument Kit is used to insert OsteoSponge SC grafts to fill bone defects in the subchondral region of articulating joints. The Instrument Kit is used to establish and maintain a port of entry for arthroscopic instruments or for an open procedure. The kit is also used to insert the OsteoSponge¿ SC graft during surgery. Such procedures include, but are not limited to, subchondral bone repair. Affected Part numbers are 6508 and 6511.

    FDA Enforcement
    Class II ·Terminated·Bacterin International, Inc.·April 15, 2015

    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

    Promote Quadra, Sterile EO, Model # / Part #: CD3221-36/100025054, 60019195; CD3223-36P/100013763; CD3239-40/100029115, 100029254, 100037181; CD3239-40Q/100029116, 100029244, 100037115

    FDA Enforcement
    Class II ·Terminated·St Jude Medical Inc.·July 4, 2018