BEUDAMED
    13 results · 22ms · Sources: EU EUDAMED, US FDA

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    OtoSet- Ear Cleaning System

    FDA 510(k)
    FDA Class 1 ·General Hospital

    DJO SURGICAL

    FDA UDI
    Encore Medical, L.P.·00190446897118·SPECIAL, EMPOWR KNEE MODULAR FEMORAL SIZER STYLUS

    NA

    FDA UDI
    Synthes GmbH·10886982143129·2.0MM LOCKING SCREW SLF-TPNG WITH STARDRIVE REC...

    Halliburton - 10 Metal

    FDA UDI
    Certified Safety Manufacturing, Inc.·00766588081779·Halliburton - 10 Metal

    MDA D-DIMER

    FDA 510(k)
    FDA Class 2 ·Hematology

    OCCLUSION BALLOON CATHETER MODEL OBC

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    REVERSE SHOULDER SYSTEM HUMERAL REVERSE METAPHYSIS +0MM/0°

    FDA Adverse Event
    Injury ·MEDACTA INTERNATIONAL SA·Product code PHX·April 11, 2024

    SERVO-I

    FDA Adverse Event
    Malfunction ·MAQUET CRITICAL CARE AB·Product code CBK·June 15, 2023

    ANIMAS INSULIN CARTRIDGE

    FDA Adverse Event
    Malfunction ·ANIMAS CORPORATION·Product code LZG·January 18, 2013

    ENRHYTHM DR

    FDA Adverse Event
    Injury ·MEDTRONIC MED REL, INC.·Product code DXY·August 11, 2011

    PORTABLE OXYGEN GENERATOR (CONCENTRATOR, HOMEFILL)

    FDA Adverse Event
    Malfunction ·INVACARE FLORIDA OPERATIONS·Product code CAW·October 27, 2014

    ACTIVA

    FDA Adverse Event
    Injury ·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code MRU·July 2, 2013

    EMBLEM MRI S-ICD pulse generators, as part of Boston Scientific S-ICD System; Model A219

    FDA Enforcement
    Class II ·Ongoing·Boston Scientific Corporation·February 3, 2021