BEUDAMED
    9 results · 27ms · 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.
    Filters Regulation: Us FDA ×

    TimeWaver Frequency

    FDA 510(k)
    FDA Class 2 ·Physical Medicine

    COMFORTMATE FLUID WARMING SYSTEM, MODEL # FW-200; COMFORTMATE DISPORSABLE DISPOSABLE WARMING SET, MODEL #FWS-200

    FDA 510(k)
    FDA Class 2 ·General Hospital

    EYE CARE CURE CONTACT LENS CASE

    FDA 510(k)
    FDA Class 2 ·Ophthalmic

    DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM

    FDA Adverse Event
    Malfunction ·DEXCOM, INC.·Product code QBJ·August 6, 2025

    OCTRODE

    FDA Adverse Event
    Injury ·ST. JUDE MEDICAL NEUROMODULATION SYSTEMS·Product code GZB·October 24, 2014

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    FDA Adverse Event
    Malfunction ·MEDTRONIC PUERTO RICO OPERATIONS MED-REL·Product code MDS·July 12, 2011

    GYNECARE PROLIFT TOTAL PELVIC FLOOR REPAIR SYSTEM

    FDA Adverse Event
    Injury ·ETHICON INC.·Product code OTP·July 9, 2013

    Allura system; System Code Description (Model Numbers): Allura Xper FD10C (722001), Allura Xper FD10F (722002), 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 OR Table (722015, 722023, 722035), Allura Xper FD20 Biplane OR Table (722025), 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), Cardio Vascular-Allura (722400);

    FDA Enforcement
    Class II ·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·May 27, 2026

    BV Pulsera with Software Release 2.3-A mobile, diagnostic X-ray image acquisition and viewing system. Model Number: 718095

    FDA Enforcement
    Class II ·Ongoing·Philips North America Llc·December 15, 2021