BEUDAMED
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    THERMO SCIENTIFIC DRI AMPHETAMINES ASSAY

    FDA 510(k)
    FDA Class 2 ·Clinical Toxicology

    APEX Knee System

    FDA UDI
    Omni Life Science, Inc.·00841690127147·AK3 PS Insert Trial Size 1, 14mm

    LEONE SPA

    FDA UDI
    LEONE SPA·08033707001294·THREE DIRECT SCREW 2 ANAT INOX 14mm

    NUMED TYSHAK AND Z-MED PTV CATHETERS

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    BCS SYSTEM

    FDA 510(k)
    FDA Class 2 ·Hematology

    OT VERIO IQ METER

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

    HEARTSTART MRX

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

    8800

    FDA Adverse Event
    Malfunction ·GE MED SYSTEMS (INDIA) PRIVATE LTD (GE PRIVATE)·Product code JAA·May 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

    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