BEUDAMED
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    PULSE GEN MODEL UNK

    FDA Adverse Event
    Malfunction ·LIVANOVA USA, INC.·Product code LYJ·April 9, 2021

    ACCU-CHEK ® SPIRIT COMBO

    FDA Adverse Event
    Injury ·ROCHE DIABETES CARE, INC.·Product code LZG·June 29, 2016

    ORION RC SCS IPG

    FDA Adverse Event
    Injury ·ABBOTT MEDICAL·Product code LGW·December 4, 2025

    ART THERAPY

    FDA Adverse Event
    Injury ·UNKNOWN·Product code PWE·November 21, 2025

    AUTONOMOUS USER REHABILITATION AGENT

    FDA Adverse Event
    Death ·UNK·Product code PWE·April 14, 2022

    UNKNOWN MONO/POLYAXIAL SCREWS

    FDA Adverse Event
    Injury ·MEDOS INTERNATIONAL SàRL CH·Product code NKB·January 2, 2020

    UNKNOWN MONO/POLYAXIAL SCREWS

    FDA Adverse Event
    Injury ·MEDOS INTERNATIONAL SàRL CH·Product code NKB·January 2, 2020

    UNKNOWN MONO/POLYAXIAL SCREWS

    FDA Adverse Event
    Injury ·MEDOS INTERNATIONAL SàRL CH·Product code NKB·January 2, 2020

    reSET-O Mobile App, iOS and Android, provides cognitive behavioral therapy, as part of substance abuse treatment.

    FDA Recall
    Terminated ·Pear Therapeutics, Inc.·Product code PWE·June 7, 2021

    reSET Mobile App, iOS and Android, provides cognitive behavioral therapy, as part of substance abuse treatment.

    FDA Recall
    Terminated ·Pear Therapeutics, Inc.·Product code PWE·June 7, 2021

    Computerized Behavioral Therapy Device For Substance Use Disorders

    FDA classification
    FDA Class 2 ·Computerized Behavioral Therapy Device For Substance Use Disorders

    USA Elite

    FDA UDI
    Gyrus ACMI, LLC·00821925038653·ACMI USA Elite System and USA Series Self Seali...

    PIE MEDICAL IMAGING B.V.

    FDA registration
    PIE MEDICAL IMAGING B.V.·4 products·🇳🇱 Netherlands

    IDEIA PCE CHLAMYDIA

    FDA 510(k)
    FDA Class 1 ·Microbiology

    VCA Lite

    FDA UDI
    Pce, Inc.·00860009492905·5.3 cc Vaginal Cream Applicator in a 7-pack can...

    VCA Lite

    FDA UDI
    Pce, Inc.·00860009492912·5.3 cc Vaginal Cream Applicator 3-Pack. Three ...

    GN ReSound

    FDA UDI
    Gn Hearing A/S·05708296126378·HI,RS VOT950-DWE ITE

    GN ReSound

    FDA UDI
    Gn Hearing A/S·05708296126361·HI,RS VOT930-DWE ITC

    ENVISION G31 P.E. PAK

    FDA 510(k)
    FDA Class 2 ·Ophthalmic

    Olimax/Wildcat Isolation Gown

    FDA UDI
    Wildcat Ppe LLC·00860009514119·Non Surgical Disposable Isolation Gown AAMI Lev...