BEUDAMED
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    ANNE Pediatric

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    Uro-Cath® Molded-Latex Male External Catheter, 30mm with Urofoam®-2 & Uro-Prep®

    FDA UDI
    UROCARE PRODUCTS, INC.·00792293221537·These male external catheters are commonly refe...

    CD HORIZON® Spinal System

    FDA UDI
    MEDTRONIC SOFAMOR DANEK, INC.·00885074362175·SCREW 7221530 HA COATED CANN 5.5 X 30

    Phasix

    FDA UDI
    Davol Inc.·00801741163227·Phasix ST Mesh with Open Positioning System, 15...

    SIMPLICITY EASY P SOFT INFUSION SET FOR INFUSION AND/OR INJECTION OF FLUIDS INTO THE BODY BELOW THE SURFACE OF THE SKIN

    FDA 510(k)
    FDA Class 2 ·General Hospital

    BODYFIX SYSTEM

    FDA 510(k)
    FDA Class 2 ·Radiology

    WALLSTENT-UNI ENDOPROSTHESIS WITH UNISTEP PLUS DELIVERY SYSTEM

    FDA Adverse Event
    Malfunction ·BOSTON SCIENTIFIC·Product code NIO·November 5, 2008

    3.5MM LAT SERFAS ENERGY PROBE

    FDA Adverse Event
    Injury ·STRYKER ENDOSCOPY PUERTO RICO·Product code GEI·August 17, 2011

    DUROM ACETABULAR COMPONENT 54/48 CODE N

    FDA Adverse Event
    Injury ·ZIMMER GMBH·Product code KWA·July 9, 2013

    Exactech Equinoxe GLENOID,KEELED, CEMENTED,47, 50, 53 head, beta curvature, Sizes: a) Small, Item Number 314-02-12, b) Medium, Item Number 314-02-13, c) Large, Item Number 314-02-14, d) Extra Large, Item Number 314-02-15, Shoulder Arthroplasty

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

    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