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

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    SFI-BAR (R) IMPLANT ADAPTER SPI (R) ELEMENT PF 0 4.0 / H 3.0 / H 4.0 / H 5.0 / H 6.0, SFI-BAR (R) IMPLANT ADAPTER STRA..

    FDA 510(k)
    FDA Class 2 ·Dental

    AOS TIBIAL NAIL 11mm x 39.0cm

    FDA UDI
    ADVANCED ORTHOPAEDIC SOLUTIONS, INC.·00848665016260·

    Surgical Instrument

    FDA UDI
    Jeil Medical Corporation·08800089473687·

    Millennium

    FDA UDI
    Avalign Technologies, Inc.·00190776164676·HEANEY RETR. . D.E. .

    Sklar®

    FDA UDI
    SKLAR CORPORATION·10649111136863·ESMARCH HVY PLASTER SHEARS 9"

    FASTPACK TSH IMMUNOASSAY

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    BONUS-ORTHOPEDIC BONE SCREW FIXATION SYSTEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    GMK FIXED POSTERO STABILIZED TIBIAL INSERT

    FDA Adverse Event
    Injury ·MEDACTA INTERNATIONAL, SA·Product code JWH·November 22, 2013

    DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM

    FDA Adverse Event
    Malfunction ·DEXCOM, INC.·Product code QBJ·May 13, 2024

    DEXCOM G6 CONTINUOUS GLUCOSE MONITORING SYSTEM

    FDA Adverse Event
    Malfunction ·DEXCOM, INC.·Product code QBJ·September 28, 2018

    TOTAL HIP BALL 28MM +0

    FDA Adverse Event
    Injury ·DEPUY ORTHOPAEDICS, INC.·Product code JDI·September 29, 2015

    ANIMAS INSULIN CARTRIDGE

    FDA Adverse Event
    Malfunction ·ANIMAS CORPORATION·Product code LZG·September 23, 2014

    ASR UNI FEMORAL IMPL SIZE 43

    FDA Adverse Event
    Injury ·DEPUY INTERNATIONAL, LTD.·Product code KWA·May 13, 2011

    BD INSYTE ¿ IV CATHETER WINGED

    FDA Adverse Event
    Malfunction ·BECTON DICKINSON MEDICAL (SINGAPORE)·Product code FOZ·February 26, 2018

    ZIMMER AIR DERMATOME

    FDA Adverse Event
    Malfunction ·ZIMMER SURGICAL, INC.·Product code GFD·June 13, 2019

    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

    EMBLEM S-ICD pulse generators, as part of Boston Scientific S-ICD System; Model A209

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

    Model Number L131, ESSENTIO DR EL MRI Pacemaker

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