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

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    AGC TOTAL KNEE PROSTHESIS

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    PRECEPTIS TYMPANOSTOMY TUBE INSERTER

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

    AMMONIA-L3K ASSAY, CATALOGUE NUMBER 233-10

    FDA 510(k)
    FDA Class 1 ·Clinical Chemistry

    BRAVO

    FDA Adverse Event
    Malfunction ·GIVEN IMAGING LTD.·Product code FFT·November 7, 2012

    DIALYSATE CONCENTRATE FOR HEMODIALYSIS (LIQUID OR POWDER)

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - SANTIAGO·Product code KPO·May 27, 2014

    SEALPTFE

    FDA Adverse Event
    Other ·VASCUTEK LTD.·Product code DSY·September 9, 2010

    KANGAROO

    FDA Adverse Event
    Malfunction ·CARDINAL HEALTH·Product code KNT·June 12, 2024

    Exactech Equinoxe REVERSE SHOULDER,42mm Constrained Humeral Liner, a) +0mm, Item number 320-42-10, b) +2.5mm, Item Number 320-42-13; Shoulder Arthroplasty

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

    Zimmer, Cuff Tourniquet Dual Hose Single Bladder Maroon Reprocessed by Sterilmed, Sterile EO, Rx only.

    FDA Enforcement
    Class II ·Terminated·STERILMED, INC.·December 16, 2015