BEUDAMED
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    2001 SPECIAL PROCEDURE LAMP (LOW VOLTAGE) (AS EXHIBITS #2 & 4)

    FDA 510(k)
    FDA Class 1 ·Radiology

    Arthrex®

    FDA UDI
    ARTHREX, INC.·00888867439122·UNIVERS REVERS SIZE 4/33 STEM GUIDE PIN

    PULLUP® Adjustable Juxtacortical Fixation Device

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    Dual-Mode Mobile C-Arm (Geelin500A, Geelin500M)

    FDA 510(k)
    FDA Class 2 ·Radiology

    3.0MM CANNULATED SCREW LONG THREAD/34MM

    FDA Adverse Event
    Injury ·SYNTHES MONUMENT·Product code HWC·February 19, 2013

    ENDURANT II ILIAC STENT GRAFT

    FDA Adverse Event
    Injury ·MEDTRONIC IRELAND·Product code MIH·September 24, 2020

    EVOLUT R TRANSCATHETER AORTIC VALVE

    FDA Adverse Event
    Injury ·MEDTRONIC HEART VALVES DIVISION·Product code NPT·February 2, 2018

    SYNCHROMED II

    FDA Adverse Event
    Injury ·MEDTRONIC NEUROMODULATION·Product code LKK·February 8, 2013

    SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE

    FDA Adverse Event
    Injury ·BAXTER HEALTHCARE·Product code KDJ·July 22, 2014

    FLEXTEND

    FDA Adverse Event
    Injury ·CPI - DEL CARIBE·Product code NVN·January 6, 2011

    COREVALVE TRANSCATHETER AORTIC VALVE

    FDA Adverse Event
    Injury ·MEDTRONIC HEART VALVES DIVISION·Product code NPT·February 2, 2018

    UNK-CV-SR

    FDA Adverse Event
    Injury ·MEDTRONIC IRELAND·Product code MIH·July 28, 2025

    PM1214 NUANCE SR RF; PM1230 and PM2230 NUANCE MRI; PM2214 NUANCE DR RF 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