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

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    TURBIDOMETRIC STANDARD

    FDA 510(k)
    FDA Class 2 ·Microbiology

    DeRoyal

    FDA UDI
    DEROYAL INDUSTRIES, INC.·00749756393690·ORTHO BASIC PACK

    MINMED QUICK SET

    FDA Adverse Event
    Malfunction ·UNOMEDICAL A/S·Product code FPA·July 13, 2024

    GYRUS ACMIL BIPOLARLAPROSCOPIC LOOP (PKS BILL)

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

    INFARED EAR THERMOMETER, MODEL TH8 SERIES

    FDA 510(k)
    FDA Class 2 ·General Hospital

    UNKNOWN TIBIAL BASEPLATE

    FDA Adverse Event
    Injury ·STRYKER ORTHOPAEDICS MAHWAH·Product code JWH·January 4, 2013

    ANEURX AAADVANTAGE STENT GRAFT SYSTEM - HYDRO

    FDA Adverse Event
    Injury ·MEDTRONIC CARDIOVASCULAR GALWAY·Product code MIH·November 24, 2010

    UNIFY ASSURA DR CRT-D

    FDA Adverse Event
    Malfunction ·ST. JUDE MEDICAL, INC., CRMD·Product code NIK·July 2, 2014

    3) Signa Advantage (K911959 Signa Advantage MR System) A magnetic resonance diagnostic device is intended for general diagnostic use to present images which reflect the spatial distribution and/or magnetic resonance spectra which reflect frequency and distribution of nuclei exhibiting nuclear magnetic resonance. Other physical parameters derived from the images and/or spectra may also be produced. The device includes hydrogen-1 (proton) imaging, sodium-23 imaging, hydrogen-1 spectroscopy, phosphorus-31 spectroscopy, and chemical shift imaging (preserving simultaneous frequency and spatial information).

    FDA Recall
    Terminated ·GE Healthcare, LLC·Product code LNH·November 9, 2010

    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