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

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    OCS-B

    FDA 510(k)
    FDA Class 2 ·Dental

    Solstice Occipito-Cervico-Thoracic System

    FDA UDI
    Life Spine, Inc.·00190837038816·AO Torque Limiting Straight Handle, 25 in-lbs

    DATEX-OHMEDA S/5 NETWORK AND CENTRAL '01

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    IPLAN RT

    FDA 510(k)
    FDA Class 2 ·Radiology

    DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM

    FDA Adverse Event
    Malfunction ·DEXCOM, INC.·Product code QBJ·March 17, 2026

    9600

    FDA Adverse Event
    Malfunction ·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·May 8, 2013

    FRESENIUS 2008K

    FDA Adverse Event
    Death ·FRESENIUS MEDICAL CARE NORTH AMERICA·Product code KDI·September 2, 2014

    PAINPUMP 2 BLOCKAID

    FDA Adverse Event
    Other ·STRYKER INSTRUMENTS·Product code MEB·May 31, 2011

    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

    Model Number L131, ESSENTIO DR EL MRI Pacemaker

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