BEUDAMED
    15 results · 21ms · Sources: EU EUDAMED, US FDA

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    Filters Regulation: Us FDA ×

    MESO WOUND MATRIX

    FDA 510(k)
    FDA Unclassified ·Unknown

    MASIMO LNOP/LNCS/M-LNCS MULTISITE-L OXIMETRY SENSORS

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    ABSOLUTE WHITE LIGHT

    FDA 510(k)
    FDA Class 1 ·Dental

    OT VERIO IQ METER

    FDA Adverse Event
    Malfunction ·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·May 14, 2013

    VERSYS HIP SYSTEM FEMORAL STEM

    FDA Adverse Event
    Injury ·ZIMMER, INC.·Product code LZO·September 17, 2014

    TOTALCARE

    FDA Adverse Event
    Malfunction ·HILL-ROM, INC.·Product code FNL·May 25, 2011

    BD MAX¿ ENTERIC PARASITE PANEL

    FDA Adverse Event
    Malfunction ·GENEOHM SCIENCES CANADA, INC. (BD DIAGNOSTICS)·Product code OOI·September 3, 2025

    BD MAX¿ ENTERIC PARASITE PANEL

    FDA Adverse Event
    Malfunction ·GENEOHM SCIENCES CANADA, INC. (BD DIAGNOSTICS)·Product code OOI·September 3, 2025

    BD MAX¿ ENTERIC PARASITE PANEL

    FDA Adverse Event
    Malfunction ·GENEOHM SCIENCES CANADA, INC. (BD DIAGNOSTICS)·Product code OOI·September 3, 2025

    HAMMER

    FDA Adverse Event
    Malfunction ·EIT EMERGING IMPLANT TECHNOLOGIES GMBH·Product code LXH·February 11, 2020

    BD MAX¿ ENTERIC PARASITE PANEL

    FDA Adverse Event
    Malfunction ·GENEOHM SCIENCES CANADA, INC. (BD DIAGNOSTICS)·Product code OOI·November 22, 2024

    HAMMER

    FDA Adverse Event
    Malfunction ·EIT EMERGING IMPLANT TECHNOLOGIES GMBH·Product code MAX·February 11, 2020

    Breast Pack - contains Devon Light Glove Used during surgery

    FDA Enforcement
    Class II ·Completed·Stradis Healthcare, LLC.·July 15, 2015

    EMBLEM S-ICD Model A209

    FDA Enforcement
    Class I ·Terminated·Boston Scientific Corporation·February 17, 2021

    INLIVEN CRT-P, Model Numbers: a) V284 b) V285 c) W274 d) W275 (added 7/15/2021)

    FDA Enforcement
    Class I ·Ongoing·Boston Scientific Corporation·July 21, 2021