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

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    ImagingRing System on Rails

    FDA 510(k)
    FDA Class 2 ·Radiology

    VONFLEX PUTTY

    FDA 510(k)
    FDA Class 2 ·Dental

    PREMIO 10 MOXA

    FDA 510(k)
    FDA Class 2 ·Physical Medicine

    XEN 45 GTS

    FDA Adverse Event
    Injury ·ALLERGAN (IRVINE)·Product code KYF·January 15, 2020

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    FDA Adverse Event
    Injury ·MEDTRONIC MINIMED·Product code OYC·October 21, 2014

    GYNECARE GYNEMESH* PS

    FDA Adverse Event
    Injury ·ETHICON INC.·Product code OTO·June 26, 2013

    ACCU-CHEK D-TRONPLUS

    FDA Adverse Event
    Malfunction ·ROCHE INSULIN DELIVERY SYSTEMS, INC.·Product code LZG·July 27, 2011

    GXL acetabular liners, orthopedic hip implant component. Product Line Numbers: a. ACUMATCH 15 DEGREE LINER 22MM SZ C, REF 132-22-03 b. ACUMATCH 15 DEGREE LINER 28MM SZ D, REF 13-28-04

    FDA Enforcement
    Class II ·Ongoing·Exactech, Inc.·September 21, 2022

    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