BEUDAMED
    13 results · 23ms · Sources: EU EUDAMED, US FDA

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    TAMINA 3.5mm Proximal Humerus System; POYA 3.5MM Lateral Proximal Tibia System; LORRAINE 3.5mm Distal Humerus System

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    BD BBL™ Sensi-Disc™ Nitrofurantoin 100 µg

    FDA UDI
    BECTON, DICKINSON AND COMPANY·30382902312926·BD BBL™ Sensi-Disc™ Nitrofurantoin 100 µg

    Dornier MedTech

    FDA UDI
    DORNIER MEDTECH AMERICA, INC.·00810116022403·365 micron core/730 micron OD Luer Lock Diode L...

    ELMED

    FDA UDI
    ELMED INCORPORATED·00842180183612·Prism Cervical Curette, 10", Straight 2, Dark B...

    Sklar®

    FDA UDI
    SKLAR CORPORATION·10649111165528·SKLRLITE PRECIS SCIS CVD 3.5

    MODIFICATION TO FOSSA URETERAL STONE SWEEPER

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

    DEROYAL SPINE SPACER SYSTEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    OPTILITE® FREELITE® KAPPA FREE KIT

    FDA Adverse Event
    Injury ·THE BINDING SITE LIMITED·Product code DFH·March 30, 2026

    OPTILITE® FREELITE® KAPPA FREE KIT

    FDA Adverse Event
    Injury ·THE BINDING SITE LIMITED·Product code DFH·March 31, 2026

    PORTABLE OXYGEN GENERATOR (CONCENTRATOR, HOMEFILL)

    FDA Adverse Event
    Malfunction ·INVACARE FLORIDA OPERATIONS·Product code CAW·September 1, 2011

    TENDRIL STS

    FDA Adverse Event
    Malfunction ·ST. JUDE MEDICAL, INC., CRMD·Product code NVN·November 6, 2014

    INTERSTIM II

    FDA Adverse Event
    Injury ·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code EZW·July 17, 2013

    Revogene, Catalog no. 610210. IVD test instrument

    FDA Enforcement
    Class II ·Ongoing·Meridian Bioscience Inc·August 3, 2022