BEUDAMED
    13 results · 27ms · Sources: EU EUDAMED, US FDA

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    Ultimax-i, DREX-UI80 V1.60

    FDA 510(k)
    FDA Class 2 ·Radiology

    SILICONE MCP

    FDA UDI
    Stryker GmbH·00886385021935·Broach, Size 40

    BINAXNOW COVID-19 ANTIGEN SELF-TEST

    FDA Adverse Event
    Malfunction ·ABBOTT DIAGNOSTICS SCARBOROUGH, INC.·Product code QKP·May 20, 2022

    BINAXNOW¿ COVID-19 ANTIGEN SELF TEST

    FDA Adverse Event
    Malfunction ·ABBOTT DIAGNOSTICS SCARBOROUGH, INC·Product code QKP·December 31, 2021

    ORTHOHELIX STAPLE SYSTEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    FORTEX PEDICLE SCREW SYSTEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    HERMETIC LARGE STYLE VENTRICULAR CATHETER SET

    FDA Adverse Event
    Injury ·INTEGRA NEUROSCIENCES PR·Product code JXG·December 13, 2017

    POD PACKING COIL

    FDA Adverse Event
    Malfunction ·PENUMBRA, INC.·Product code HCG·November 8, 2017

    RESERVOIR 1.8ML

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

    PALIND 19/36 SLOT SPRT W/VT

    FDA Adverse Event
    Malfunction ·COVIDIEN LP·Product code MSD·May 23, 2013

    HEARTSTART MRX

    FDA Adverse Event
    Malfunction ·PHILIPS HEALTHCARE - ANDOVER·Product code MKJ·June 22, 2011

    POD PACKING COIL

    FDA Adverse Event
    Malfunction ·PENUMBRA, INC.·Product code HCG·October 23, 2017

    CADD-Solis VIP ambulatory Infusion Pumps, Model 2110. Indicated for the following uses: Intra-arterial, subcutaneous, intraperitoneal, in close proximity to nerves, into an intraoperative site, epidural space or subarachnoid space. Therapies that require a continuous rate of infusion, intermittent bolus, and/or with patient-controlled demand doses.

    FDA Enforcement
    Class I ·Ongoing·Smiths Medical ASD Inc.·August 14, 2024