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

    FDA 510(k)
    FDA Class 2 ·General Hospital

    DeRoyal

    FDA UDI
    DEROYAL INDUSTRIES, INC.·00749756000758·Knee Immobilizer

    N/A

    FDA UDI
    BIOMET MICROFIXATION, INC·00841036006884·

    IRONMAN

    FDA UDI
    FGX INTERNATIONAL INC.·00193033344880·

    IRONMAN

    FDA UDI
    FGX INTERNATIONAL INC.·00193033344927·

    TiWAVE L Lumbar Cage System

    FDA UDI
    Kalitec Direct LLC·B07323K0101070·Distractor, Smooth Paddle, Lordotic, 7mm

    InTess Lumbar Cage

    FDA UDI
    Kalitec Direct LLC·B07312K0101070·Distractor, Smooth Paddle, 7mm

    IRONMAN

    FDA UDI
    FGX INTERNATIONAL INC.·00193033344903·

    IRONMAN

    FDA UDI
    FGX INTERNATIONAL INC.·00193033344910·

    IRONMAN

    FDA UDI
    FGX INTERNATIONAL INC.·00193033344897·

    COCAINE METABOLITE INTERCEPT MICRO-PLATE EIA

    FDA 510(k)
    FDA Class 2 ·Clinical Toxicology

    CORTEK CYSTOSCOPE

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

    RAPIDLAB 1245

    FDA Adverse Event
    Death ·SIEMENS HEALTHCARE DIAGNOSTICS, MFG LTD·Product code CHL·March 8, 2013

    ANIMAS INSULIN CARTRIDGE

    FDA Adverse Event
    Malfunction ·ANIMAS CORPORATION·Product code LZG·August 14, 2014

    POLYFLUX LR CAPILLARY DIALYZER

    FDA Adverse Event
    Malfunction ·GAMBRO DIALYSATOREN GMBH·Product code MSF·March 10, 2008

    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

    Boston Scientific TELIGEN, Implantable Cardiac Defibrillator models E102, E110, the following models are not available in the US: models F102, F110, F111. Sterilized using ethylene oxide. Boston Scientific, 4100 Hamline Avenue North, St. Paul, MN 55112-5798 USA. Indicated for patients who are at risk for sudden cardiac death due to ventricular arrhythmias and may require pacing support.

    FDA Enforcement
    Class II ·Terminated·Boston Scientific CRM Corp·October 23, 2013