BEUDAMED
    11 results · 35ms · Sources: EU EUDAMED, US FDA

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    MISTY OX DISPOS. NEBULIZER

    FDA 510(k)
    FDA Class 1 ·Anesthesiology

    BANANA KNIFE - K841969-LABELING

    FDA 510(k)
    FDA Class 1 ·General, Plastic Surgery

    CAMELBACK HANDLE-K841969-LABELING

    FDA 510(k)
    FDA Class 1 ·Orthopedic

    2.5MM & 4MM PROBE K841969-LABELING

    FDA 510(k)
    FDA Class 1 ·Orthopedic

    ANTERIOR COMPACT SYSTEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    iQ 2 Nasal Vented Mask; Phantom 2 Nasal Vented Mask

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM

    FDA Adverse Event
    Malfunction ·DEXCOM, INC.·Product code MDS·May 30, 2014

    GOBED II MED/SURG BED

    FDA Adverse Event
    Malfunction ·STRYKER MEDICAL·Product code FNL·October 24, 2012

    HEARTSTART MRX - EMS DEFIBRILLATOR

    FDA Adverse Event
    Malfunction ·PHILIPS HEALTHCARE·Product code MKJ·September 16, 2010

    Pinnacle Cups, Part numbers 121701048 121701050 121701052 121701054 121701056 121701058 121701060 121701062 121711048 121711052 121712050 121712052 121712056 121722048 121722050 121722052 121722054 121722056 121722058 121722060 121722062 121731048 121731050 121731052 121731054 121731056 121731058 121731060 121731062 121732048 121732050 121732052 121732054 121732056 121732058 121732060 121732062 121732064 - Product Usage: The PINNACLE CUP devices are part of the Pinnacle Hip Solution for the anatomic reconstruction of the hip joint, which promotes prosthetic joint load and function.

    FDA Enforcement
    Class II ·Terminated·DePuy Orthopaedics, Inc.·January 13, 2021

    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