BEUDAMED
    12 results · 19ms · Sources: EU EUDAMED, US FDA

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    CEMPER

    FDA 510(k)
    FDA Class 2 ·Dental

    ReLine

    FDA UDI
    Nuvasive, Inc.·00195377068811·RELINE C Screw, 4.0x24mm MA

    Bioseal Inc.

    FDA UDI
    BIOSEAL·00630094190402·Coronary Tourniquet

    Solstice Occipito-Cervico-Thoracic System

    FDA UDI
    Life Spine, Inc.·00190837014582·

    STAINLESS STEEL DENTAL WIRES AND CLASPS

    FDA 510(k)
    FDA Class 1 ·Dental

    BI-O.K. STEAM TEST-PAK

    FDA 510(k)
    FDA Class 2 ·General Hospital

    SOLETRA

    FDA Adverse Event
    Malfunction ·MEDTRONIC NEUROMODULATION·Product code MHY·January 9, 2013

    UNICEL® DXC 800 PRO SYNCHRON® CHEMISTRY ANALYZER

    FDA Adverse Event
    Malfunction ·BECKMAN COULTER INC.·Product code JJE·November 21, 2010

    OT VERIO IQ METER

    FDA Adverse Event
    Malfunction ·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·July 1, 2014

    Brand Name: ReQuest Measles IgM Product Name: Enzyme Linked Immunoabsorbant Assay, Rubeola IgM Model/Catalog Number: 01-190M Software Version: N/A Product Description: Measles IgM tests, performed using ELISA (Enzyme-Linked Immunosorbent Assay) method, used to detect the presence of IgM antibodies against measles virus in a patient's serum or plasma Component: not a component

    FDA Enforcement
    Class II ·Ongoing·Quest International, Inc.·September 17, 2025

    smiths medical Pneupac paraPAC plus 300 ventilator kit without PEEP and CPAP, REF P300NUS

    FDA Enforcement
    Class I ·Ongoing·Smiths Medical ASD Inc.·March 27, 2024

    paraPAC 300 ventilator kit without internal PEEP and CPAP, Item Number P300N

    FDA Enforcement
    Class I ·Ongoing·Smiths Medical ASD Inc.·October 2, 2024