BEUDAMED
    11 results · 18ms · Sources: EU EUDAMED, US FDA

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    HINGED KNEE

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    Modulus

    FDA UDI
    Nuvasive, Inc.·00195377049704·Modulus ALIF HL Trial, 12x38x28mm 30°

    Polystar Selection EDITION

    FDA UDI
    Merz Dental GmbH·D7091982160·posteriors; shade A2 light; size XL; upper jaw

    1688 Camera Control Unit ; 1688 AIM 4K Camera Head, C-Mount ; 1688 AIM 4K Camera Head with Integrated Coupler ; AIM 4K Coupler, 20mm, C-Mount ; L11 LED Light Source with AIM

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

    TOTAL IRON IN SERUM

    FDA 510(k)
    FDA Class 1 ·Clinical Chemistry

    1688 AIM 4K CAMERA HEAD WITH INTEGRATED COUPLER - INTERNATIONAL KIT

    FDA Adverse Event
    Malfunction ·STRYKER ENDOSCOPY-SAN JOSE·Product code GCJ·September 13, 2024

    HARMONIC FOCUS* CURVED SHEARS, TORQUE WRENCH AND GRIP ASSIST

    FDA Adverse Event
    Malfunction ·ETHICON ENDO-SURGERY, LLC.·Product code LFL·February 28, 2013

    CAPSUREFIX NOVUS

    FDA Adverse Event
    Death ·MEDTRONIC PUERTO RICO, INC.·Product code DTB·February 9, 2011

    UNKNOWN DEPUY ASR FEMORAL HEAD

    FDA Adverse Event
    Injury ·DEPUY INTL., LTD. - 8010379·Product code KXA·August 5, 2014

    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

    Azurion 7 M20; System Code: (1)722079, (2)722224, (3)722234, (4)722282 (OUS only);

    FDA Enforcement
    Class II ·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·April 8, 2026