BEUDAMED
    10 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.

    MAJOR DRESSING TRAY

    FDA 510(k)

    Savant Lumbar Interbody Fusion System

    FDA UDI
    CURITEVA, INC.·B648C41428110900·Titanium TLIF Spacer, 28 x 11 x 9mm, 0 deg

    Savant Lumbar Interbody Fusion System

    FDA UDI
    CURITEVA, INC.·B648C40428110900·PEEK TLIF Spacer, 28 x 11 x 9mm, 0 deg

    Portex

    FDA UDI
    ICU MEDICAL, INC.·15019517077100·

    ZENEX Implant System

    FDA 510(k)
    FDA Class 2 ·Dental

    Invacare® Solara® 3G and Solara® 3G Spree Manual Wheelchairs

    FDA 510(k)
    FDA Class 1 ·Physical Medicine

    SPECTRUM INFUSION PUMP

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE CORP·Product code FRN·January 9, 2014

    SPRINT QUATTRO SECURE

    FDA Adverse Event
    Injury ·MEDTRONIC PUERTO RICO, INC.·Product code LWS·October 31, 2012

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    FDA Adverse Event
    Malfunction ·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OYC·June 2, 2015

    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