BEUDAMED
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    ARIX Sternal System

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    NITREX

    FDA UDI
    Covidien LP·00821684058190·Guidewire

    NITREX™

    FDA UDI
    EV3, INC·00763000185435·GW N181806 NITREX V04

    NITREX

    FDA UDI
    Covidien LP·10821684009090·Guidewire

    PILLING

    FDA UDI
    TELEFLEX INCORPORATED·24026704512878·

    restor3d Utility Wedge

    FDA UDI
    Restor3d, Inc.·00840097504933·Ti Anatomic Evans Wedge, Small Footprint, 6mm T...

    Origin Short Neck Collared Hip Stem

    FDA UDI
    SIGNATURE ORTHOPAEDICS PTY LTD·09348215024017·

    SiNAPTIC Osteotomy Wedge System

    FDA UDI
    SINTX Technologies, Inc.·G817S101181806·Evans Wedge, 18W x 18D x 6H

    AIDERA DIASEND SYSTEM

    FDA 510(k)
    FDA Class 2 ·General Hospital

    IDI IMPLANT SYSTEM

    FDA 510(k)
    FDA Class 2 ·Dental

    311NNM NARROWAND UV PHTOTHERAPY LIGHT LAMP

    FDA Adverse Event
    Injury ·XUZHOU KERNEL MEDICAL INSTRUMENT EQUIPMENT CO LTD.·Product code FTC·December 22, 2022

    SHOULDER SYSTEM

    FDA Adverse Event
    Injury ·MEDACTA INTERNATIONAL SA·Product code PHX·July 28, 2025

    COLLEAGUE PRE P1.7

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·July 27, 2011

    SYNCHROMED II

    FDA Adverse Event
    Injury ·MDT PUERTO RICO OPERATIONS CO·Product code LKK·June 21, 2013

    GE OEC 9900

    FDA Adverse Event
    Malfunction ·GE OEC MEDICAL SYSTEMS INC·Product code JAA·September 19, 2008

    SHOULDER SYSTEM

    FDA Adverse Event
    Injury ·MEDACTA INTERNATIONAL SA·Product code PHX·October 8, 2025

    REVERSE SHOULDER SYSTEM GLENOID POLYAXIAL NON-LOCKING SCREW - L46

    FDA Adverse Event
    Injury ·MEDACTA INTERNATIONAL SA·Product code PHX·July 27, 2022

    REVERSE SHOULDER SYSTEM HUMERAL REVERSE METAPHYSIS +0MM/0

    FDA Adverse Event
    Injury ·MEDACTA INTERNATIONAL SA·Product code PHX·March 9, 2021

    CAREEVENT REL A.0

    FDA Adverse Event
    Injury ·PHILIPS MEDICAL SYSTEMS·Product code MSX·March 21, 2018

    Boston Scientific COGNIS CRT-D, Cardiac Resynchronization Therapy Defibrillator, models N118, N119. The following models are not available in the US: models N106, N107, P106, P107. Sterilized using ethylene oxide. Product Usage: Boston Scientific cardiac resynchronization therapy defibrillators (CRT-Ds) are indicated for patients with moderate to severe heart failure who remain symptomatic despite stable, optimal heart failure drug therapy and have left ventricular dysfunction and QRS duration > or equal to 120 ms. This family of pulse generators provide a variety of therapies including: -Ventricular tachyarrhythmia therapy, which is used to treat rhythms associated with sudden cardiac death such as VT and VF; -Cardiac Resynchronization Therapy (CRT), which treats heart failure by resynchronizing ventricular contractions through biventricular electrical stimulation; -Bradycardia pacing, including adaptive rate pacing, to detect and treat bradyarrhythmias and to provide cardiac rate support after defibrillation therapy.

    FDA Enforcement
    Class II ·Terminated·Boston Scientific CRM Corp·October 29, 2014