BEUDAMED
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    TOTAL BILE ACIDS ASSAY, MODEL DZ042A

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    Specials

    FDA UDI
    Seaspine Orthopedics Corporation·10889981255619·Paddle Distractor, 14mm

    MERCURY MEDICAL HYPERINFLATION BAG SYSTEM, MODEL 83-900-0149

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    BIPAP PRO BI-LEVEL SYSTEM

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    DIMENSION EXL 200

    FDA Adverse Event
    Malfunction ·SIEMENS HEALTHCARE DIAGNOSTICS INC·Product code JGS·April 10, 2013

    ENRHYTHM DR

    FDA Adverse Event
    Injury ·MEDTRONIC MED REL, INC.·Product code DXY·April 12, 2011

    ACCU-CHEK COMFORT CURVE TEST STRIPS

    FDA Adverse Event
    Malfunction ·ROCHE DIAGNOSTICS CORP.·Product code LFR·May 19, 2008

    Arrow AutoCAT2 Intra-Aortic Balloon Pump, AUTOCAT2 WAVE, REF IAP-0500 (IPN000320), cardiac pump

    FDA Enforcement
    Class I ·Ongoing·ARROW INTERNATIONAL Inc.·December 21, 2022

    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