BEUDAMED
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    VALIDATE URINE CHEMISTRY CALIBRATION VERIFICATION TEST SETS

    FDA 510(k)
    FDA Class 1 ·Clinical Chemistry

    Clear Anatomical Face Mask

    FDA UDI
    MERCURY ENTERPRISES, INC.·10641043505045·

    Marina Medical

    FDA UDI
    MARINA MEDICAL INSTRUMENTS, INC.·00840306814679·Nail Splitting Scissors, 15cm

    Azur Pure Helical

    FDA UDI
    Microvention, Inc.·00810170018657·Azur

    InTess Lumbar Cage

    FDA UDI
    Kalitec Direct LLC·B07312K0105040·Implant Inserter, 11-13mm, Sleeveless

    INFRARED EAR THERMOMETER, MODELS TH88 SERIES

    FDA 510(k)
    FDA Class 2 ·General Hospital

    ADVANTA SUPER SOFT GRAFT

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    Philips HeartStart FRx 861304 Automated External Defibrillator Manufactured by Philips Medical Systems, Seattle, WA 98121 USA; and Laerdal branded FRx 861305 The FRx Defibrillator is intended to treat ventricular fibrillation, the most common cause of sudden cardiac arrest. Using voice prompts, light emitting diodes (LEDs) and buttons, the user is guided through the response. The FRx uses a SMART biphasic, impedance compensating exponential waveform to deliver a nominal 150 J to adults and nominal 50 J to infants/children.

    FDA Enforcement
    Class II ·Terminated·Philips Medical Systems North America Co. Phillips·January 16, 2013

    9900

    FDA Adverse Event
    Malfunction ·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·April 8, 2013

    HEARTSTART MRX - EMS DEFIBRILLATOR

    FDA Adverse Event
    Malfunction ·PHILIPS HEALTHCARE·Product code MKJ·April 5, 2011

    TENDRIL SDX

    FDA Adverse Event
    Injury ·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code DTB·May 27, 2008

    Depuy brand ACE trochanteric nail end cap, non-sterile, 25 mm; Product 903008025.

    FDA Recall
    Terminated ·Depuy Orthopaedics, Inc.·Product code HSB·December 11, 2003

    Belmont Rapid Infuser, a Fluid Management System, Model FMS2000.

    FDA Enforcement
    Class II ·Terminated·Belmont Instrument Corporation·October 24, 2012

    Reprocessed Pressure Tourniquet Cuff (PTC) Tourniquet cuffs are single- or dual-bladder inflatable cuffs connected to a tourniquet system via a hose assembly. When wrapped around a limb and inflated, tourniquet cuffs apply an adequate amount of pressure on the arterial blood flow in a limb to create a bloodless surgical field. Tourniquet cuffs are available in a variety of sizes to accommodate a wide range of limb circumferences.

    FDA Enforcement
    Class II ·Terminated·Stryker Sustainability Solutions·November 9, 2016