BEUDAMED
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    da Vinci Surgical System Model IS5000, da Vinci Insufflator and Tube Set with Smoke Evacuation

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology

    5MP GRAYSCALE LCD DISPLAY

    FDA 510(k)
    FDA Class 2 ·Radiology

    MODIFIED SONAMET BODY COMPOSITION ANALYZER

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    PLATE, FIXATION, BONE

    FDA Adverse Event
    Injury ·SYNTHES (USA)·Product code HRS·November 6, 2014

    CD HORIZON® SPINAL SYSTEM

    FDA Adverse Event
    Malfunction ·MEDTRONIC SOFAMOR DANEK·Product code KWP·September 2, 2011

    GYNECARE TVT-AA ABDOMINAL

    FDA Adverse Event
    Injury ·ETHICON INC.·Product code OTN·July 18, 2013

    M2A MAGNUM SYSTEM

    FDA Adverse Event
    Injury ·BIOMET ORTHOPEDICS·Product code KWA·March 31, 2017

    RingLoc+ Quick Connect Drill Bit, Item numbers 31-323215, 31-323220, 31-323230, 31-323240 - Product Usage: Bit, Drill.

    FDA Enforcement
    Class II ·Terminated·Biomet, Inc.·December 23, 2020

    BIOMET StageOne Select, Hip Stem Cement Spacer Mold w/Reinforcement Cement, 9 X 125 MM, Silicone, Sterile, Item 431190.

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

    Exactech Equinoxe REVERSE SHOULDER,38mm Constrained Humeral Liner: a) +0mm, Item Number 320-38-10, b) +2.5mm, Item Number 320-38-13, Shoulder Arthroplasty

    FDA Enforcement
    Class II ·Ongoing·Exactech, Inc.·April 10, 2024

    Model Number L111, ESSENTIO DR SL MRI Pacemaker

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

    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