BEUDAMED
    18 results · 22ms · Sources: EU EUDAMED, US FDA

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    Filters Regulation: Us FDA ×

    N Latex FLC kappa assay, N Latex FLC Lambda assay, N FLC Standard SL, N FLC Control SL1 & SL2

    FDA 510(k)
    FDA Class 2 ·Immunology

    NA

    FDA UDI
    KEY SURGICAL, INC.·10849771050114·Steinmann Pins, Double diamond, threaded, 9/64-...

    KMEDIC

    FDA UDI
    TELEFLEX INCORPORATED·24026704294040·

    SOLID CANCELLOUS LAG SCREW

    FDA UDI
    Biomet Orthopedics, LLC·00887868005152·

    BEAUTIFIL II

    FDA 510(k)
    FDA Class 2 ·Dental

    THERMO SCIENTIFIC CEDIA COCAINE OFT ASSAY

    FDA 510(k)
    FDA Class 2 ·Clinical Toxicology

    BD VACUTAINER® BLOOD COLLECTION TUBE

    FDA Adverse Event
    Malfunction ·BECTON, DICKINSON & CO., (BD)·Product code JKA·December 1, 2017

    (17-1742) ANK TITANIUMBASE /X

    FDA Adverse Event
    Injury ·DENTSPLY IMPLANTS (A DIVISION OF DENTSPLU IH AB)·Product code DZE·March 10, 2021

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    FDA Adverse Event
    Malfunction ·ANIMAS CORPORATION·Product code LZG·October 14, 2014

    OT PING ENHANCED METER

    FDA Adverse Event
    Malfunction ·LIFESCAN EUROPE GMBH·Product code NBW·June 16, 2013

    COLLEAGUE PRE P1.7

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·July 22, 2011

    CONTOUR® NEXT

    FDA Adverse Event
    Malfunction ·ASCENSIA DIABETES CARE US INC.·Product code JJX·September 4, 2025

    NEU_INTERSTIM_INS

    FDA Adverse Event
    Injury ·MEDTRONIC NEUROMODULATION·Product code EZW·March 9, 2018

    NEU_INTERSTIM_INS

    FDA Adverse Event
    Injury ·MEDTRONIC NEUROMODULATION·Product code EZW·March 9, 2018

    NEU_INTERSTIM_INS

    FDA Adverse Event
    Injury ·MEDTRONIC NEUROMODULATION·Product code EZW·March 9, 2018

    NEU_INTERSTIM_INS

    FDA Adverse Event
    Injury ·MEDTRONIC NEUROMODULATION·Product code EZW·March 9, 2018

    CONTOUR® PLUS

    FDA Adverse Event
    Malfunction ·ASCENSIA DIABETES CARE US INC.·Product code JJX·February 20, 2025

    Ingenia 3.0T-a Magnetic Resonance Medical Electrical Systems indicated for use as a diagnostic device. The system can produce cross-sectional images, spectroscopic images and/or spectra in any orientation of the internal structure of the head, body, or extremities Models: 781342 781377

    FDA Enforcement
    Class II ·Completed·Philips North America Llc·September 15, 2021