BEUDAMED
    13 results · 20ms · Sources: EU EUDAMED, US FDA

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    Solawave 2-in-1 Skincare Mini (Model: 61043)

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

    Millennium

    FDA UDI
    Avalign Technologies, Inc.·00190776082130·Cholangiogram Clamp

    Millennium

    FDA UDI
    Avalign Technologies, Inc.·00190776159825·Cholangiogram Clamp, 5mm, ratchet handle 27cm

    ELMED

    FDA UDI
    ELMED INCORPORATED·00842180158535·5 MM DIA., 27 CM CHOLANGIOGRAM CLAMP

    NA

    FDA UDI
    aap Implantate AG·04042409038341·Parallel guide for K-wires, CS 7.5

    CHLORINATED POWDER FREE LATEX EXAMINATION GLOVES WITH PROTEIN LABELING CLAIM (CONTAINS 50 MICROGRAMS OR LESS OF TOTAL WA

    FDA 510(k)
    FDA Class 1 ·General Hospital

    Universal Light Handle Cover, Light Handle Cover

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

    LIFEVEST WCD 3000 SYSTEM

    FDA Adverse Event
    Malfunction ·ZOLL LIFECOR CORPORATION·Product code MVK·November 14, 2008

    OT PING METER

    FDA Adverse Event
    Malfunction ·LIFESCAN INC.·Product code NBW·September 16, 2011

    GYNECARE TVT RETROPUBIC SYSTEM

    FDA Adverse Event
    Injury ·ETHICON INC.·Product code OTN·July 26, 2013

    Radial Artery Pressure Monitoring Catheter Sets and Trays The subject sets and trays are comprised of a single-lumen uncoated or heparin-coated catheter. Product catalog numbers with heparin coating are designated by the suffix BH.

    FDA Enforcement
    Class I ·Terminated·Cook Inc.·March 2, 2016

    BioGX SARS-CoV-2 Reagents for BD MAX System-IVD PCR test intended for the qualitative detection of nucleic acid from the SARS-CoV-2 in nasopharyngeal specimens Catalog Number: 444213

    FDA Enforcement
    Class II ·Terminated·Becton Dickinson & Co.·April 21, 2021

    Boston Scientific TELIGEN, Implantable Cardiac Defibrillator models E102, E110, the following models are not available in the US: models F102, F110, F111. Sterilized using ethylene oxide. Boston Scientific, 4100 Hamline Avenue North, St. Paul, MN 55112-5798 USA. Indicated for patients who are at risk for sudden cardiac death due to ventricular arrhythmias and may require pacing support.

    FDA Enforcement
    Class II ·Terminated·Boston Scientific CRM Corp·October 23, 2013