BEUDAMED
    8 results · 17ms · Sources: EU EUDAMED, US FDA

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    HCC-MYCOBACTERIA STAIN KIT

    FDA 510(k)
    FDA Class 1 ·Microbiology

    NATURAL COMFORT DOUBLE ELECTRIC/BATTERY BREAST PUMP, MODEL 1181/1068

    FDA 510(k)
    FDA Class 2 ·Obstetrics/Gynecology

    LKB-WALLACE 1250 LUMINOMETER

    FDA 510(k)
    FDA Class 1 ·Clinical Chemistry

    ACCU-CHEK ® AVIVA TEST STRIPS

    FDA Adverse Event
    Malfunction ·ROCHE DIAGNOSTICS·Product code LFR·May 27, 2014

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    FDA Adverse Event
    Malfunction ·ANIMAS CORPORATION·Product code LZG·November 15, 2012

    SYNCHROMED II

    FDA Adverse Event
    Death ·MDT PUERTO RICO OPERATIONS CO., JUNCOS·Product code LKK·September 3, 2010

    Exactech Equinoxe GLENOID,KEELED, CEMENTED, Mates with 38, 41, 44 head, alpha curvature, Sizes: a), Small, Item Number 314-01-02; b) Medium, Item number 314-01-03; c) Large, Item Number 314-01-04, Shoulder Arthroplasty

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

    OPTETRAK Comprehensive Knee System including OPTETRAK RBK PS Tibial Components. NOTE: Information reflects Exactech recall expansion initiated on 02/07/2022.

    FDA Enforcement
    Class II ·Ongoing·Exactech, Inc.·October 13, 2021