BEUDAMED
    11 results · 30ms · Sources: EU EUDAMED, US FDA

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    URIS Smart Path Implant System & Prosthetic

    FDA 510(k)
    FDA Class 2 ·Dental

    AXLE INTERSPINOUS FUSION SYSTEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    BARD AQUAGUIDE URETERAL CONDUIT

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology

    PSX INTERBODY SYSTEM

    FDA Adverse Event
    Injury ·ALPHATEC SPINE, INC.·Product code MAX·April 29, 2025

    MONOPOLAR CURVED SCISSORS INSTRUMENT

    FDA Adverse Event
    Malfunction ·INTUITIVE SURGICAL, INC.·Product code GEI·November 7, 2008

    RESTORE ULTRA

    FDA Adverse Event
    Injury ·MEDTRONIC PUERTO RICO OPERATIONS CO., JUNCOS·Product code LGW·August 15, 2011

    SOLYX SIS SYSTEM

    FDA Adverse Event
    Injury ·BOSTON SCIENTIFIC - MARLBOROUGH·Product code FTL·July 16, 2013

    PREVI COLOR GRAM REAGENT IODINE-B (NA), CATALOG 29586

    FDA Enforcement
    Class II ·Ongoing·Biomerieux Inc·January 11, 2023

    Injection needle, bayonet, Luer-Lock, 1. Model no. 50-353-23, working length 25 cm, total length 31cm, nonsterile; 2. Model no. 50-345-23, working length 24 cm, total length 31 cm, non-sterile

    FDA Enforcement
    Class II ·Ongoing·Spiggle & Theis Mt Gmbh·August 27, 2025

    Evidence MultiSTAT with software v 3.7-Analyzer intended for the qualitative determination of parent drug molecule and metabolites of drugs in human urine Catalog Number: EV4115

    FDA Enforcement
    Class III ·Ongoing·Randox Laboratories Ltd.·May 15, 2024

    Model Number L111, ESSENTIO DR SL MRI Pacemaker

    FDA Enforcement
    Class I ·Ongoing·Boston Scientific Corporation·October 22, 2025