BEUDAMED
    12 results · 21ms · Sources: EU EUDAMED, US FDA

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    Orthopantomograph™ OP 3D LX (PAN 3D); Orthopantomograph™ OP 3D LX (PAN CEPH 3D)

    FDA 510(k)
    FDA Class 2 ·Radiology

    Altor Safety 3-Ply Surgical Mask (Model:62222)

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

    L1P-1F (TRIOS 5)

    FDA 510(k)
    FDA Class 2 ·Dental

    PENTAX

    FDA Adverse Event
    Malfunction ·HOYA CORPORATION PENTAX TOKYO OFFICE·Product code PEA·June 14, 2024

    PENTAX

    FDA Adverse Event
    Malfunction ·HOYA CORPORATION PENTAX TOKYO OFFICE·Product code PEA·July 22, 2024

    PENTAX

    FDA Adverse Event
    Malfunction ·HOYA CORPORATION PENTAX TOKYO OFFICE·Product code FDS·January 10, 2025

    9900

    FDA Adverse Event
    Malfunction ·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·August 17, 2011

    SPIDERFX EMBOLIC PROTECTION DEVICE

    FDA Adverse Event
    Injury ·EV3 INC.·Product code NTE·November 7, 2008

    DIMENSION® CLINICAL CHEMISTRY SYSTEM

    FDA Adverse Event
    Malfunction ·SIEMENS HEALTHCARE DIAGNOSTICS INC·Product code MLM·July 22, 2013

    ASSURE PRISM BLOOD GLUCOSE TEST SYSTEM

    FDA Adverse Event
    Injury ·I-SENS·Product code NBW·March 26, 2024

    Vantage Total Ankle System including a. Vantage Fixed-Bearing Polyethylene Liner Component (Product Line: 350-21-XX, 350-22-XX); b. Vantage Mobile-Bearing Polyethylene Liner Component (Product Line: 350-41-XX, 350-42-XX). NOTE: Information reflects Exactech recall expansion initiated on 02/07/2022.

    FDA Enforcement
    Class II ·Ongoing·Exactech, Inc.·October 13, 2021

    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