BEUDAMED
    13 results · 27ms · Sources: EU EUDAMED, US FDA

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    IPD Dental Implant Abutments

    FDA 510(k)
    FDA Class 2 ·Dental

    HEALIX PEEK ORTHOCORD

    FDA UDI
    Medos International Sàrl·10886705007639·HEALIX PEEK Anchor w/ORTHOCORD and Needles PEEK...

    TALOS® IBF

    FDA UDI
    MEDITECH SPINE, LLC·B167310222215110·

    NAVIGATOR DELIVERY SYSTEM (NAVIGATOR DS)

    FDA 510(k)
    FDA Class 2 ·General Hospital

    cobas BKV, cobas EBV/BKV Control Kit, cobas Buffer Negative Control Kit

    FDA 510(k)
    FDA Class 2 ·Microbiology

    UNICEL DXC 800 PRO SYNCHRON SYSTEM

    FDA Adverse Event
    Malfunction ·BECKMAN COULTER·Product code JJE·November 3, 2014

    OXFORD PARTIAL KNEE SYSTEM LEFT MEDIAL TIBIAL TRAY SZ A

    FDA Adverse Event
    Injury ·BIOMET UK LTD·Product code NRA·August 24, 2011

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    FDA Adverse Event
    Malfunction ·ANIMAS CORPORATION·Product code LZG·July 12, 2013

    VITROS 350 CHEMISTRY SYSTEM

    FDA Adverse Event
    Malfunction ·ORTHO-CLINICAL DIAGNOSTICS·Product code JJE·July 30, 2018

    ALLURA Xper FD20 Biplane; System Code: (1) 722008, (2)722013;

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

    Exactech Equinoxe REVERSE SHOULDER,46mm Humeral Liner, a) +0mm, Item number 320-46-00, b) +2.5mm, Item Number 320-46-03; Shoulder Arthroplasty

    FDA Enforcement
    Class II ·Ongoing·Exactech, Inc.·April 10, 2024

    Philips Allura Xper Systems (R7.6-R8.1). Labeled as the following: 1. Allura Xper FD10, Model Number: 722010. 2. Allura Xper FD10/10, Model Number: 722011. 3. Allura Xper FD20, Model Number: 722012. 4. Allura Xper FD20 Biplane, Model Number: 722013. 5. Allura Xper FD10 OR Table, Model Number: 722022. 6. Allura Xper FD20 OR Table, Model Number: 722023. 7. Allura Xper FD20 Biplane OR Table, Model Number: 722025.

    FDA Enforcement
    Class II ·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·December 18, 2024

    Model Number L111, ESSENTIO DR SL MRI Pacemaker

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