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

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    ArtPix Mobile EZ2GO

    FDA 510(k)
    FDA Class 2 ·Radiology

    MEDI

    FDA UDI
    MEDI MANUFACTURING, INC.·04049772814213·GENUMEDI PT SILVER L IV

    Bernafon

    FDA UDI
    Bernafon AG·05711584058985·SU9 P, VC PS SABE/MAC SUITE 9

    RESPCARE HYBRID AV MASK

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    PIXI PEDIATRIC MASK

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    T:SLIM G5 SYSTEM

    FDA Adverse Event
    Malfunction ·TANDEM DIABETES CARE·Product code OYC·June 11, 2019

    PENUMA IMPLANT

    FDA Adverse Event
    Injury ·INTERNATIONAL MEDICAL DEVICES, INC.·Product code MIB·October 7, 2019

    LUMENIS PULSE 120H

    FDA Adverse Event
    Malfunction ·LUMENIS LTD.·Product code GEX·June 21, 2022

    KARL STORZ

    FDA Adverse Event
    Other ·KARL STORZ GMBH & CO. KG·Product code GEI·April 19, 2013

    TOTAL ASR FEM IMP SIZE 47

    FDA Adverse Event
    Injury ·DEPUY INTERNATIONAL, LTD.·Product code KWA·July 7, 2011

    COMPAX 40E

    FDA Adverse Event
    Malfunction ·GE MEDICAL SYSTEMS, LLC·Product code IZZ·September 16, 2008

    Medtronic MiniMed(TM) Mio(TM) (MMT-921, 921T, 923, 923T, 925, 925T, 941, 941T, 943, 943T, 945, 945T, 961, 963, 963T, 965, 965T, 975, 975T)

    FDA Enforcement
    Class II ·Ongoing·Medtronic Inc.·November 29, 2017

    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