BEUDAMED
    14 results · 20ms · Sources: EU EUDAMED, US FDA

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    DeScribe Transparent PFD Patch

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

    DIVERGENCE-L™ Anterior/Oblique Lumbar Fusion System

    FDA UDI
    MEDTRONIC SOFAMOR DANEK, INC.·00643169524781·GUIDE 2150212 O51 SCREW GUIDE 12MM

    APEX Revision Knee

    FDA UDI
    Omni Life Science, Inc.·00841690122708·Modular Stem 21mm x 125mm

    Accent Buccal Tube

    FDA UDI
    ORMCO CORPORATION·00889989054026·ACCENT B/T 5SGL 2ND WDX -10TX18 UL

    Ophthalmic Speculum

    FDA UDI
    KATENA PRODUCTS, INC.·00841668100066·TEMPORAL SPECULUM CLOSED WIRE

    PERSONAL WARMING JELLY

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

    DENTACENTER/EXPEDITION, MODEL SAF-430

    FDA 510(k)
    FDA Class 1 ·Dental

    OT VERIO FLEX METER

    FDA Adverse Event
    Malfunction ·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·April 1, 2015

    PAINSMART IOD

    FDA Adverse Event
    Malfunction ·MOOG DEVICE GROUP·Product code FRN·May 29, 2013

    CUB PEDIATRIC CRIB- HYD BASE

    FDA Adverse Event
    Malfunction ·STRYKER MEDICAL·Product code FMS·June 10, 2011

    TAXUS EXPRESS2 PACLITAXEL-ELUTING CORONARY STENT SYSTEM

    FDA Adverse Event
    Injury ·BOSTON SCIENTIFIC·Product code NIQ·August 28, 2008

    INRATIO PT/INR TEST STRIPS

    FDA Adverse Event
    Injury ·ALERE SAN DIEGO, INC·Product code GJS·July 14, 2017

    GLUC/LAC CASSETTE

    FDA Adverse Event
    Malfunction ·Product code KHP·August 9, 2010

    paraPAC plus 310 ventilator kit with internal PEEP and CPAP, Item Number P310N

    FDA Enforcement
    Class I ·Ongoing·Smiths Medical ASD Inc.·October 2, 2024