BEUDAMED
    9 results · 18ms · Sources: EU EUDAMED, US FDA

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    REPLACE-A-TIP RECHARGEABLE HIGH TEMP

    FDA 510(k)
    FDA Class 2 ·Ophthalmic

    NEEDLE VIEW CH SCOPE KITS

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    MEDCOMMONS OPEN RADIOLOGY GATEWAY

    FDA 510(k)
    FDA Class 2 ·Radiology

    SURESCAN

    FDA Adverse Event
    Injury ·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code LGW·May 30, 2014

    UNKNOWN IMPLANTABLE NEUROSTIMULATOR

    FDA Adverse Event
    Malfunction ·MEDTRONIC NEUROMODULATION·Product code LGW·November 21, 2012

    LAP-BAND AP ADJUSTABLE GASTRIC BANDING SYSTEM (STANDARD)

    FDA Adverse Event
    Injury ·ALLERGAN·Product code LTI·September 13, 2010

    PM3544 QUADRA RELIEVE and PM3562 QUADRA ALLURE MP These low voltage (LV) devices are implantable pacemaker pulse generators, intended to be permanently implanted in the body, that have a power supply and electronic circuits that produce a periodic electrical pulse to stimulate the heart. These devices are used as a substitute for the heart's intrinsic pacing system to correct both intermittent and continuous cardiac rhythm disorders

    FDA Enforcement
    Class II ·Terminated·St Jude Medical Inc.·October 25, 2017

    Zimmer, Cuff Tourniquet Dual Hose Single Bladder Maroon Reprocessed by Sterilmed, Sterile EO, Rx only.

    FDA Enforcement
    Class II ·Terminated·STERILMED, INC.·December 16, 2015

    Azurion 7 M20; System Code: (1)722079, (2)722224, (3)722234, (4)722282 (OUS only);

    FDA Enforcement
    Class II ·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·April 8, 2026