BEUDAMED
    19 results · 24ms · Sources: EU EUDAMED, US FDA

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    i-STAT CHEM8+ cartridge with the i-STAT 1 System

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    CoRoent

    FDA UDI
    Nuvasive, Inc.·00887517576323·CoRoent Ant TLIF Ti, 9x11x36mm 0°

    PIVOX™ Oblique Lateral Spinal System

    FDA UDI
    MEDTRONIC SOFAMOR DANEK, INC.·00643169599185·TRIAL 2191360 O25 IB 27MM 6 DEG 12X60

    Sonic

    FDA UDI
    Sonic Innovations, Inc.·05711583032054·ET20 MNR, 2.4G NFM PB DG DEMO ENCHANT 20

    SHEAUMANN PL-980

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

    CLEARFLUX DIALYZER REPROCESSING SYSTEM

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology

    INTELLAMAP ORION?

    FDA Adverse Event
    Malfunction ·BOSTON SCIENTIFIC CORPORATION·Product code DRF·May 12, 2026

    INTELLAMAP ORION

    FDA Adverse Event
    Injury ·BOSTON SCIENTIFIC CORPORATION·Product code DRF·April 15, 2025

    INTELLAMAP ORION

    FDA Adverse Event
    Injury ·BOSTON SCIENTIFIC CORPORATION·Product code DRF·April 29, 2026

    INTELLAMAP ORION?

    FDA Adverse Event
    Malfunction ·BOSTON SCIENTIFIC CORPORATION·Product code DRF·April 17, 2026

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    FDA Adverse Event
    Malfunction ·ANIMAS CORPORATION·Product code LZG·October 21, 2014

    PREFYX PPS SYSTEM

    FDA Adverse Event
    Injury ·BOSTON SCIENTIFIC - SPENCER·Product code FTL·June 26, 2013

    SM104 MSERIES W5TH WHL

    FDA Adverse Event
    Malfunction ·STRYKER MEDICAL·Product code FPO·July 28, 2011

    INTELLAMAP ORION?

    FDA Adverse Event
    Injury ·BOSTON SCIENTIFIC CORPORATION·Product code DRF·January 30, 2026

    INTELLAMAP ORION?

    FDA Adverse Event
    Malfunction ·BOSTON SCIENTIFIC CORPORATION·Product code DRF·April 1, 2026

    INTELLAMAP ORION

    FDA Adverse Event
    Injury ·BOSTON SCIENTIFIC CORPORATION·Product code DRF·November 21, 2024

    INTELLAMAP ORION?

    FDA Adverse Event
    Injury ·BOSTON SCIENTIFIC CORPORATION·Product code DRF·February 26, 2026

    INTELLAMAP ORION

    FDA Adverse Event
    Malfunction ·BOSTON SCIENTIFIC CORPORATION·Product code DRF·December 12, 2024

    Allura Exper FD Series. System codes 722003 722010 722022 722005 722011 722019 722001 722002 722006 722012 722008 722013 722020 722025 722015 722023 722038 889006 889016 889009 722005 The device is an X-Ray Generator.

    FDA Enforcement
    Class II ·Terminated·Philips North America, LLC·March 25, 2020