BEUDAMED
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    HILARIS-NORI ENDOMETRIAL APPLICATOR

    FDA 510(k)
    FDA Class 1 ·Radiology

    N/A

    FDA UDI
    MEDTRONIC SOFAMOR DANEK, INC.·00613994287816·CASE 9871216 LID

    VITROS CHEMISTRY PRODUCTS CRSC SLIDES, VITROS CHEMISTRY PRODUCTS DT CALIBRATOR KIT, MODEL 680 2721, 195 7927

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    CENTRIFICHEM TRIGLYCEOIDE CALI, STD. SET

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    AIR DERMATOME HANDPIECE

    FDA Adverse Event
    Malfunction ·ZIMMER SURGICAL·Product code GFD·April 16, 2014

    PORTEX SPINAL ANESTHESIA TRAYS

    FDA Adverse Event
    Injury ·SMITHS MEDICAL ASD, INC.·Product code CAZ·October 11, 2010

    OT VERIO IQ METER

    FDA Adverse Event
    Malfunction ·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·December 12, 2012

    PM3544 QUADRA RELIEVE and PM3562 QUADRA ALLURE MP These low voltage (LV) devices are implantable pacemaker pulse generators, intended to be permanently implanted in the body, that have a power supply and electronic circuits that produce a periodic electrical pulse to stimulate the heart. These devices are used as a substitute for the heart's intrinsic pacing system to correct both intermittent and continuous cardiac rhythm disorders

    FDA Enforcement
    Class II ·Terminated·St Jude Medical Inc.·October 25, 2017

    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