BEUDAMED
    9 results · 23ms · Sources: EU EUDAMED, US FDA

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    GelPOINT V-Path Transvaginal Access Platform with Retroperitoneal Access Device

    FDA 510(k)
    FDA Class 2 ·Obstetrics/Gynecology

    TM-ABI system

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    VERTEBRON PSS PEDICLE SCREW SYSTEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    CLINITEK STATUS+

    FDA Adverse Event
    SIEMENS HEALTHCARE DIAGNOSTICS·Product code JIL·May 16, 2016

    I-STAT EC8+ CARTRIDGE

    FDA Adverse Event
    Malfunction ·ABBOTT POINT OF CARE INC.·Product code CHL·March 4, 2025

    INFINITI VISION SYSTEM

    FDA Adverse Event
    Injury ·ALCON - IRVINE TECHNOLOGY CENTER·Product code HQC·November 21, 2008

    UNICEL® DXC 600I SYNCHRON® ACCESS® CLINICAL SYSTEM

    FDA Adverse Event
    Malfunction ·BECKMAN COULTER INC.·Product code JJE·September 12, 2011

    SMALL HARVESTER HANDLE MODULAR

    FDA Adverse Event
    Malfunction ·SEASPINE, INC.·Product code MAX·July 18, 2013

    ACCOLADE DR SL MRI (Model L311)

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