BEUDAMED
    9 results · 26ms · Sources: EU EUDAMED, US FDA

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    Portrait GBS Assay

    FDA 510(k)
    FDA Class 1 ·Microbiology

    UPD-Y0003

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology

    NOBELRONDO DENTAL CERAMIC - ZIRCONIA

    FDA 510(k)
    FDA Class 2 ·Dental

    HEARTMATE 3 LEFT VENTRICULAR ASSIST SYSTEM

    FDA Adverse Event
    Malfunction ·THORATEC CORPORATION·Product code DSQ·October 26, 2020

    DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM

    FDA Adverse Event
    Malfunction ·DEXCOM, INC.·Product code QBJ·May 1, 2026

    OBTAPE TRANSOBTURATOR SLING

    FDA Adverse Event
    Injury ·MENTOR WORLDWIDE LLC·Product code OTN·May 23, 2013

    COLLEAGUE PRE P1.7

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·June 28, 2011

    MAESTRO SMALL FIXED DURAGUARD

    FDA Adverse Event
    Malfunction ·STRYKER INSTRUMENTS-KALAMAZOO·Product code ERL·October 6, 2014

    Azurion 3 M15; Catalog numbers: (1) 722064, (2) 722222 (3) 722280(OUS ONLY).

    FDA Enforcement
    Class I ·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·February 26, 2025