BEUDAMED
    11 results · 21ms · Sources: EU EUDAMED, US FDA

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    Persyst 15 EEG Review and Analysis Software (Persyst 15 (P15))

    FDA 510(k)
    FDA Class 2 ·Neurology

    APEX Knee System

    FDA UDI
    Omni Life Science, Inc.·00841690192206·Apex Revision Knee Reamer – ZIMMER SHORT FLUTES...

    Autoimmune EIA

    FDA UDI
    BIO-RAD LABORATORIES, INC.·00847817018282·Autoimmune EIA Anti-Phosphatidylserine IgA Test...

    Corneal Trephine

    FDA UDI
    KATENA PRODUCTS, INC.·00841668112953·CORNEAL TREPHINE BLADE8.5MM

    ONE TOUCH ULTRA

    FDA Adverse Event
    Malfunction ·LIFESCAN, INC.·Product code CFR·September 17, 2002

    ACUITY CENTRAL STATION, MODEL 020XXXXX (NOTE: XXXXX = VARIOUS CONFIG.)

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    Navik 3D

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    COLLEAGUE

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·September 16, 2011

    530G INSULIN PUMP

    FDA Adverse Event
    Malfunction ·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OZO·November 14, 2014

    EON MINI

    FDA Adverse Event
    Injury ·ST. JUDE MEDICAL - NEUROMODULATION·Product code LGW·July 25, 2013

    Exactech Equinoxe GLENOID,KEELED, CEMENTED, mates with 47, 50, 53 head, beta curvature, Sizes: a) Small, Item Number 314-01-12, b) Medium, Item Number 314-01-13, c) Large, Item Number 314-01-14, Shoulder Arthroplasty

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