BEUDAMED
    7 results · 18ms · 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.

    FRAME, UNIVERSAL DAY

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    DHEA TEST SET

    FDA 510(k)
    FDA Class 1 ·Clinical Chemistry

    PHILIPS MP5 AND MP5T INTELLIVUE PATIENT MONITORS AND TRX4841A INTELLIVUE TELEMETRY SYSTEM TRANSCEIVER

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    RIATA ST OPTIM ACTIVE FIXATION

    FDA Adverse Event
    Death ·ST. JUDE MEDICAL, INC., CRMD·Product code NVY·April 30, 2014

    POWERED WHEELCHAIR

    FDA Adverse Event
    Malfunction ·INVACARE SUZHOU·Product code ITI·October 11, 2012

    MONOPTY DISPOSABLE CORE BIOPSY INSTRUMENT

    FDA Adverse Event
    Malfunction ·BARD PERIPHERAL VASCULAR, INC.·Product code KNW·April 16, 2015

    Philips Allura Xper Interventional Fluoroscopic X-ray Systems, specifically the Disk Bay of the PC component of affected systems. Affected PCs: FlexVision PC Allura Xper Model Name - Model Number: Allura Xper FD10 722003 722010 722026; Allura Xper FD10/10 722005 722011 722027; Allura Xper FD20 722006 722012 722028; Allura Xper FD20 Biplane 722008 722013; Allura Xper FD20 Biplane OR Table 722025; Allura Xper FD20 OR Table 722023 722035; Allura Xper FD20/10 722029; Allura Xper FD20/15 722058; Allura Xper FD20/15 OR Table 722059; Allura Xper FD20/20 722038; Allura Xper FD20/20 OR Table 722039;

    FDA Enforcement
    Class II ·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·February 28, 2024