BEUDAMED
    8 results · 20ms · 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.

    PILLOWS- SINGLE PATIENT USE

    FDA 510(k)
    FDA Class 1 ·General Hospital

    Helix

    FDA UDI
    Nuvasive, Inc.·00887517120724·Helix-T Plate, 54mm 3-Level

    CIMPAT (PINK AND WHITE)

    FDA 510(k)
    FDA Class 2 ·Dental

    074 Zenith Flex System

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    PRECISION®

    FDA Adverse Event
    Malfunction ·BOSTON SCIENTIFIC NEUROMODULATION·Product code LGW·April 30, 2014

    8800

    FDA Adverse Event
    Malfunction ·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·October 10, 2012

    PUMP MMT-722NAL PRDGM INS V2.2 CL EN PR

    FDA Adverse Event
    Malfunction ·MEDTRONIC PUERTO RICO OPERATIONS MED REL·Product code MDS·July 29, 2010

    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