BEUDAMED
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    OW100S

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

    BIOCRYL

    FDA UDI
    DEPUY MITEK, LLC·10886705010608·BIOCRYL INTERFERENCE SCREW Absorbable - TCP/PLA...

    Dornier MedTech

    FDA UDI
    DORNIER MEDTECH AMERICA, INC.·00810116022427·400 micron core/730 micron OD Luer Lock Diode L...

    Orfit Industries

    FDA UDI
    Orfit Industries NV·05420028784914·Pressure System Bridge - High Variable Height

    Ophthalmic Knife

    FDA UDI
    KATENA PRODUCTS, INC.·00841668101186·GILL CORNEAL KNIFE CURVED

    DRILL, AO, STERILE 4, 2X340 MM

    FDA Adverse Event
    Malfunction ·STRYKER OSTEOSYNTHESIS KIEL·Product code LXH·September 23, 2011

    MERIT HYDROPHILIC GUIDE WIRE

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    OLYMPUS ULTRASONIC SURGICAL SYSTEM

    FDA 510(k)
    FDA Unclassified ·Unknown

    ROTALINK? BURR

    FDA Adverse Event
    Injury ·BOSTON SCIENTIFIC - CORK·Product code MCX·November 6, 2014

    RIATA ST OPTIM ACTIVE FIXATION

    FDA Adverse Event
    Death ·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code NVY·September 1, 2011

    ENTERPRISE VASCULAR RECONSTRUCTION DEVICE AND DELIVERY SYSTEM

    FDA Adverse Event
    Malfunction ·CORDIS NEUROVASCULAR, INC.·Product code NJE·July 17, 2013

    Revogene, Catalog no. 610210. IVD test instrument

    FDA Enforcement
    Class II ·Ongoing·Meridian Bioscience Inc·August 3, 2022

    BIOMET StageOne Knee Femoral Cement Spacer Mold, 70 MM, Silicone, Sterile, Item 432170.

    FDA Enforcement
    Class II ·Terminated·Biomet, Inc.·April 15, 2020

    Coronary Sinus (CS) Uni-Directional Diagnostic Electrophysiology (EP) Catheter, catalog numbers D135303 and D135304. Product Usage: The Reprocessed CS Diagnostic EP Catheter is indicated for electrophysiological mapping of cardiac structures; i.e., stimulation and recording only. The catheter is designed for use in the coronary sinus.

    FDA Enforcement
    Class II ·Terminated·Stryker Sustainability Solutions·July 18, 2018

    Brand Name: SenTiva" Product Name: VNS Therapy" SenTiva", Model 1000 Model/Catalog Number: 1000 Software Version: NA Product Description: The LivaNova VNS Therapy" System, used for Vagus Nerve Stimulation (VNS), consists of an implantable VNS Therapy generator, lead, and external programming system used to change stimulation settings. The generator is an implantable, multi-programmable pulse generator that delivers electrical signals to the vagus nerve through the lead. The generator is housed in a hermetically sealed titanium case and is powered by a single battery. Electrical signals are transmitted from the generator to the vagus nerve by the lead. The lead and the generator make up the implantable portion of the VNS Therapy System. The VNS Therapy Programming System includes a computer pre-installed with VNS Therapy programming software and a programming wand. The physician uses the programming system to read and change generator settings. The Model 1000 Generator was commercially approved for distribution in the U.S. on October 3, 2017 via PMA P970003/S210. Component: The LivaNova VNS Therapy" System, used for Vagus Nerve Stimulation (VNS).

    FDA Enforcement
    Class II ·Ongoing·LivaNova USA, Inc.·February 5, 2025