BEUDAMED
    8 results · 27ms · Sources: EU EUDAMED, US FDA

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    TANDEM - EPRL

    FDA 510(k)
    FDA Class 1 ·Clinical Chemistry

    MicroScan Dried Gram-Negative MIC/Combo Panels with Cefepime (CPE) (0.12-64 µg/mL) (MicroScan)

    FDA 510(k)
    FDA Class 2 ·Microbiology

    MYCOPLASMELISA TEST KIT

    FDA 510(k)
    FDA Class 1 ·Microbiology

    FMP HIP

    FDA Adverse Event
    Injury ·ENCORE MEDICAL, L.P.·Product code OQG·June 2, 2014

    LIFEVEST WCD 4000 SYSTEM

    FDA Adverse Event
    Malfunction ·ZOLL LIFECOR CORPORATION·Product code MVK·October 26, 2012

    PULSE GEN MODEL 102R

    FDA Adverse Event
    Injury ·CYBERONICS, INC.·Product code LYJ·September 22, 2010

    Exactech Equinoxe REVERSE SHOULDER, 38mm Humeral Liner: a) +0mm, Item Number 320-38-00, b) +2.5mm, Item Number 320-38-03; Shoulder Arthroplasty

    FDA Enforcement
    Class II ·Ongoing·Exactech, Inc.·April 10, 2024

    Unify Quadra, Sterile EO, Model #/ Part #: CD3249-40/100036404, 100038435, CD3249-40Q/100036407, 100038436, CD3251-40/100036405, 100038095, 100038226, 100038437, 100038451, 100072563, CD3251-40Q/100036408, 100038214, 100038230, 100038407, 100038442, 100072564, CD3255-40/100038224, CD3255-40Q/100036514

    FDA Enforcement
    Class II ·Terminated·St Jude Medical Inc.·July 4, 2018