BEUDAMED
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    AZUR HydroPack 18 (45-880005; 45-880010; 45-880020; 45-880035; 45-880050; 45-880060)

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    VARIAX

    FDA UDI
    Stryker GmbH·04546540540980·Tension Plier 2.3

    Ophthalmic Cannula

    FDA UDI
    KATENA PRODUCTS, INC.·00841668113653·SUB-TENONS CANNULA 19GA 25MM

    Drive Rail System

    FDA UDI
    ORTHOPEDIATRICS CORP.·00817867020627·CLAMP, 5-HOLE IN-LINE

    SPERM FREEZING MEDIUM - SpermFreeze

    FDA UDI
    INVITROCARE, INCORPORATED·00859268006329·SPERM FREEZING MEDIUM - SpermFreeze is a HEPES-...

    RELIANT BTL 5000 PULS ELECTRICAL STIMULATION SYSTEM, RELIANT BTL 5000 SONO ULTRASOUND SYSTEM, RELIANT BTL 5000 COMBI

    FDA 510(k)
    FDA Class 2 ·Physical Medicine

    EGENS ONE STEP HCG URINE PREGNANCY TEST KIT(S) (STRIP, CASSETTE, MIDSTREAM I AND MIDSTREAM II)

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    9900

    FDA Adverse Event
    Malfunction ·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·August 10, 2011

    QUARTET

    FDA Adverse Event
    Death ·ST. JUDE MEDICAL, INC., CRMD·Product code OJX·November 4, 2014

    NC TREK CORONARY DILATATION CATHETER

    FDA Adverse Event
    Malfunction ·AV-TEMECULA-CT·Product code LOX·July 12, 2013

    XP-XP Tibial Tray - Interlok 63 mm Item # 195751

    FDA Enforcement
    Class II ·Terminated·Zimmer Biomet, Inc.·September 18, 2019

    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