BEUDAMED
    10 results · 28ms · Sources: EU EUDAMED, US FDA

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    TearCare MGX System

    FDA 510(k)
    FDA Class 2 ·Ophthalmic

    BEST MODEL # 81-01 SERIES IR-192 SOURCES

    FDA 510(k)
    FDA Class 2 ·Radiology

    Ontex Unscented Tampons with Colored Plastic Applicators

    FDA 510(k)
    FDA Class 2 ·Obstetrics/Gynecology

    DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM

    FDA Adverse Event
    Malfunction ·DEXCOM, INC.·Product code QBJ·September 21, 2024

    BD ANGIOCATH

    FDA Adverse Event
    Malfunction ·BECTON DICKINSON INDUSTRIAS CIRURGICAS, LTDA.·Product code FOZ·January 17, 2025

    NAIL,FIXATION,BONE

    FDA Adverse Event
    Injury ·SYNTHES USA·Product code JDS·November 11, 2014

    UNIFY CRT-D

    FDA Adverse Event
    Injury ·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code NIK·September 10, 2011

    ELECTRIC PEN DRIVE 60,000 RPM

    FDA Adverse Event
    Malfunction ·SYNTHES GMBH·Product code HWE·July 23, 2013

    smiths medical ProPort Plastic Venous Access System, Silicone Catheter, 2.8mm (8.4Fr) O.D. x 1.0mm I.D., 9 Fr Introducer, REF 21-4151-24

    FDA Enforcement
    Class I ·Ongoing·Smiths Medical ASD, Inc.·March 26, 2025

    Model Number L111, ESSENTIO DR SL MRI Pacemaker

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