BEUDAMED
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    AUDIOSCOPE #23000 W/71123 CHARGING STAND

    FDA 510(k)
    FDA Class 1 ·Ear, Nose, Throat

    SINUS DILATION SYSTEM WITH CANNULATED INSTRUMENT

    FDA 510(k)
    FDA Class 1 ·Ear, Nose, Throat

    AcuityDR 1013 G4, AcuityDR 1417 G4, AcuityDR 1717G4

    FDA 510(k)
    FDA Class 2 ·Radiology

    ACCESS

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - AIBONITO·Product code FPA·May 26, 2014

    INFUSE BONE GRAFT

    FDA Adverse Event
    Injury ·MEDTRONIC SOFAMOR DANEK USA, INC·Product code NEK·November 14, 2012

    HS HAND CONTROLLED CURVED SHEA

    FDA Adverse Event
    Malfunction ·ETHICON ENDO SURGERY, INC. (CINCINNATI)·Product code GEI·January 4, 2008

    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

    ACCOLADE SR SL MRI (Model L310)

    FDA Enforcement
    Class I ·Ongoing·Boston Scientific Corporation·October 22, 2025

    ALLURA Xper FD20; System Code: (1) 722006, (2)722012, (3)722028;

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