BEUDAMED
    14 results · 25ms · Sources: EU EUDAMED, US FDA

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    AMB101 SYSTEM, AMBLYZ, LCG SYSTEM, XPAND

    FDA 510(k)
    FDA Class 1 ·Ophthalmic

    ihcDirect® PRAME Ab, 15mL

    FDA UDI
    NOVODIAX, INC.·00850000596566·Clone R1009

    ihcDirect® PRAME Ab, 5mL

    FDA UDI
    NOVODIAX, INC.·00850000596559·Clone R1009

    ihcDirect® PRAME Ab Conjugate 5mL

    FDA UDI
    NOVODIAX, INC.·00850030934659·Clone R1009

    ihcDirect® PRAME Ab Conjugate 15mL

    FDA UDI
    NOVODIAX, INC.·00850030934666·Clone R1009

    KINGYIELD WRIST BLOOD PRESSURE MONITOR

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    ENVISION

    FDA 510(k)
    FDA Class 2 ·Dental

    OT VERIO IQ METER

    FDA Adverse Event
    Malfunction ·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·May 29, 2013

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    FDA Adverse Event
    Malfunction ·MEDTRONIC MINIMED·Product code OYC·October 1, 2014

    CARELINK

    FDA Adverse Event
    Malfunction ·MEDTRONIC MILACA INC.·Product code DXY·June 16, 2011

    BD BACTEC¿ MGIT¿ 960 SIRE KIT

    FDA Adverse Event
    Malfunction ·BECTON, DICKINSON & CO. (SPARKS)·Product code MJA·September 19, 2023

    XVWEB

    FDA Adverse Event
    Injury ·PLANET DDS·Product code LLZ·March 13, 2025

    SECOND OPINION

    FDA Adverse Event
    Injury ·PEARL INC.·Product code MYN·March 13, 2025

    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