BEUDAMED
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    TI-BASE ABUTMENT, 1 CONNECT ABUTMENT

    FDA 510(k)
    FDA Class 2 ·Dental

    Millennium

    FDA UDI
    Avalign Technologies, Inc.·00190776305086·Mayo Dissecting Scissors, 14", curved on flat, ...

    CENTERVUE DIGITAL RETINOGRAPHY SYSTEM

    FDA 510(k)
    FDA Class 2 ·Ophthalmic

    REJUVENIQUE MODEL #RJV10

    FDA 510(k)
    FDA Class 2 ·Neurology

    DRIVER; SIZE 10

    FDA Adverse Event
    Malfunction ·K2M, INC.·Product code LXH·July 12, 2022

    GMK-SPHERE TIBIAL INSERT FIXED SPHERE FLEX SIZE 5/14 MM L

    FDA Adverse Event
    Injury ·MEDACTA INTERNATIONAL SA·Product code JWH·April 25, 2023

    HOMECHOICE

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - LARGO·Product code FKX·May 14, 2013

    ROTATING MULTIPLE CLIP APPLIER

    FDA Adverse Event
    Malfunction ·ETHICON ENDO-SURGERY, LLC.·Product code FZP·June 2, 2011

    TEC 6

    FDA Adverse Event
    Malfunction ·DATEX-OHMEDA·Product code CAD·August 11, 2008

    TOPAZ MicroDebrider 0.8 mm REF AC4040-01; TOPAZ MicroDebrider IFS 0.8 mm REF ACH4040-01; TOPAZ MicroDebrider 0.8 mm REF Q6000-01; TOPAZ EPF MicroDebrider 0.8 mm 45 REF Q6002-01

    FDA Enforcement
    Class II ·Terminated·ArthroCare Corporation·April 13, 2016

    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