BEUDAMED
    9 results · 41ms · Sources: EU EUDAMED, US FDA

    Get notified when this changes

    We'll email you when new records match this search — new devices, new clearances, certificate changes, or withdrawals.

    OPUS

    FDA Adverse Event
    Death ·ALMA LASERS, LTD·Product code GEI·November 22, 2023

    OPUS MAGNUM IMPLANT

    FDA Adverse Event
    Injury ·OPUS MEDICAL, INC.·Product code MBI·January 14, 2004

    OPUS MAGNUN ANCHOR

    FDA Adverse Event
    Injury ·OPUS MEDICAL, INC.·Product code HTY·March 29, 2002

    OPUS MAGNUM IMPLANT

    FDA Adverse Event
    Injury ·OPUS MEDICAL, INC.·Product code HTY·March 1, 2005

    OPUS MAGNUM IMPLANT

    FDA Adverse Event
    Injury ·OPUS MEDICAL, INC.·Product code HTY·October 18, 2004

    Vital Images ViTALConnect , Version 4.0 and 4.1, PET/CT Visualization option. Vital Images, Inc., 5850 Opus Parkway, Suite 300, Minnetonka, MN 55343. ( A web-based medical diagnostic tool that allows physicians to use PCs or notebook computers to gain remote access to 2D, 3D, and 4D advanced visualization. The software enables users to measure, rotate, and analyze images)

    FDA Recall
    Terminated ·Vital Images, Inc.·Product code LLZ·November 8, 2007

    HAMILTON-C2 Ventilator: Manufactured by Hamilton Medical AG CH-7402 Bonaduz, Switzerland; Imported and distributed by Hamilton Medical, Inc. Reno, NV 89502 The HAMILTON C2 ventilator is intended to provide positive pressure ventilatory support to adults, pediatrics, infants and neonates depending on its configuration. Intended areas of use: In the intensive care ward or in the recovery room; During transfer of ventilated patients within the hospital.

    FDA Enforcement
    Class II ·Terminated·Hamilton Medical, Inc.·November 13, 2013

    JaviTech e.K.

    Authorized representative
    🇩🇪 Germany·111 Manufacturers·1816 Devices

    MedEnvoy Global BV

    Authorized representative
    🇳🇱 Netherlands·143 Manufacturers·2306 Devices