BEUDAMED
    19 results · 37ms · Sources: EU EUDAMED, US FDA

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    Tyto Insights for Wheeze Detection

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    Sklar®

    FDA UDI
    SKLAR CORPORATION·10649111308383·SKLARLITE XD OLSEN-HEGAR 4 3/4

    PRODESSE PROFAST+ ASSAY

    FDA 510(k)
    FDA Class 2 ·Microbiology

    N/T PROTEIN CONTROL

    FDA 510(k)
    FDA Class 1 ·Clinical Chemistry

    PRODIGY AUTOCODE

    FDA Adverse Event
    Injury ·OK BIOTECH CO., LTD.·Product code NBW·August 4, 2017

    LAP-BAND ADJUSTABLE GASTRIC BANDING SYSTEM

    FDA Adverse Event
    Injury ·COSTA RICA·Product code LTI·November 13, 2008

    ARTHREX

    FDA Adverse Event
    Injury ·ARTREX, INC.·Product code HRX·July 25, 2011

    ENDO GIA II 60-3.5 SULU

    FDA Adverse Event
    Injury ·COVIDIEN, FORMERLY USSC·Product code GDW·July 8, 2013

    UNSPECIFIED BD VACUTAINER® SODIUM FLUORIDE/POTASSIUM OXALATE TUBES

    FDA Adverse Event
    Malfunction ·BECTON DICKINSON & CO (FRANKLIN LAKES)·Product code JKA·October 15, 2025

    RADIESSE VOICE

    FDA Adverse Event
    Other ·MERZ NORTH AMERICA INC.·Product code KHJ·March 13, 2014

    BD VACUTAINER® SODIUM FLUORIDE/POTASSIUM OXALATE 5MG/4MG

    FDA Adverse Event
    Malfunction ·BECTON, DICKINSON & CO. (BROKEN BOW)·Product code JKA·May 23, 2024

    ONYX

    FDA Adverse Event
    Injury ·MICRO THERAPEUTICS, INC. DBA EV3·Product code MFE·November 9, 2020

    UNKNOWN IMPLANTABLE NEUROSTIMULATOR

    FDA Adverse Event
    Death ·MEDTRONIC NEUROMODULATION·Product code MHY·February 17, 2015

    UNKNOWN CAGE/SPACER

    FDA Adverse Event
    Injury ·MEDOS INTERNATIONAL SàRL CH·Product code ODP·June 1, 2021

    UNK - SCREWS

    FDA Adverse Event
    Injury ·SYNTHES GMBH·Product code HWC·June 3, 2021

    UNKNOWN CAGE/SPACER

    FDA Adverse Event
    Injury ·MEDOS INTERNATIONAL SàRL CH·Product code ODP·June 1, 2021

    UNK - PLATES: SPINE

    FDA Adverse Event
    Injury ·SYNTHES GMBH·Product code ODP·June 3, 2021

    OT ULTRA METER

    FDA Adverse Event
    Injury ·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·February 28, 2018

    Model Number L111, ESSENTIO DR SL MRI Pacemaker

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