BEUDAMED
    9 results · 19ms · Sources: EU EUDAMED, US FDA

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    AMERICAN ELECTROMEDICS RACE CA TYMPANOMETER/AUDIOMETER WITH INTEGRAL PRINTER

    FDA 510(k)
    FDA Class 2 ·Ear, Nose, Throat

    Polystar Selection EDITION HD

    FDA UDI
    Merz Dental GmbH·D7091983051·posteriors; shade B2; size L; lower jaw

    Kaye Nephrostomy Tamponade Balloon Catheter and Stent Set

    FDA 510(k)
    FDA Unclassified ·Unknown

    FLOWTAIN & FLOWTAIN LV

    FDA 510(k)
    FDA Class 2 ·Dental

    LOGIC CR TIB INSERT STD, SZ 4, 9MM

    FDA Adverse Event
    Injury ·EXACTECH, INC.·Product code JWH·December 11, 2023

    HEARTWARE® VENTRICULAR ASSIST SYSTEM

    FDA Adverse Event
    Malfunction ·HEARTWARE, INC·Product code DSQ·February 28, 2013

    SIGMA FEM ADAPTER NEUTRAL BOLT

    FDA Adverse Event
    Injury ·DEPUY ORTHOPAEDICS, INC.·Product code JWH·February 4, 2011

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    FDA Adverse Event
    Malfunction ·ANIMAS CORPORATION·Product code LZG·August 6, 2014

    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