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

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    UBI MAGIWEL(TM) HELICOBACTER PYLORI IGG

    FDA 510(k)
    FDA Class 1 ·Microbiology

    HEARING AID, UNITRON MODEL VISTA 4000

    FDA 510(k)
    FDA Class 1 ·Ear, Nose, Throat

    ANTIMICROBIAL SUSCEPT TEST PANEL/ADD ANTIBIOTICS

    FDA 510(k)
    FDA Class 2 ·Microbiology

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    FDA Adverse Event
    Malfunction ·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OYC·January 22, 2013

    MICRO OSCILLATING SAW

    FDA Adverse Event
    Malfunction ·STRYKER INSTRUMENTS KALAMAZOO·Product code GFA·December 9, 2010

    ACCU-CHEK ® AVIVA TEST STRIPS

    FDA Adverse Event
    Malfunction ·ROCHE DIAGNOSTICS·Product code LFR·July 10, 2014

    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