BEUDAMED
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    aprevo® transforaminal lumbar interbody fusion device

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    MaXcess

    FDA UDI
    Nuvasive, Inc.·00887517194138·MaXcess Access Blade, 140mm Left

    Sklar®

    FDA UDI
    SKLAR CORPORATION·10649111144936·SKLARLITEXD OP SCISS SB CV41/2

    RZ Medizintechnik GmbH

    FDA UDI
    RZ-Medizintechnik GmbH·04049197306959·Tilley nasal/ear forceps 5 1/2"...

    BD ULTRA-FINE PEN NEEDLE

    FDA Adverse Event
    Malfunction ·BECTON DICKINSON AND CO.·Product code FMI·February 16, 2021

    OMNYX IDP FOR HER2 MANUAL APPLICATION

    FDA 510(k)
    FDA Class 2 ·Hematology

    WATERLASE

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

    BIOGX SARS-COV-2 OPEN SYSTEM REAGENTS FOR BD MAX SYSTEM

    FDA Adverse Event
    Malfunction ·BECTON, DICKINSON & CO. (SPARKS)·Product code QJR·May 3, 2021

    BD ULTRA-FINE PEN NEEDLE

    FDA Adverse Event
    Malfunction ·BECTON DICKINSON AND CO.·Product code FMI·March 10, 2021

    AXIUM HELIX DETACHABLE COIL

    FDA Adverse Event
    Malfunction ·EV3 NEUROVASCULAR·Product code HCG·November 12, 2008

    ENDEAVOR SPRINT RX CORONARY STENT SYSTEM

    FDA Adverse Event
    Injury ·MEDTRONIC IRELAND·Product code NIQ·August 26, 2011

    SYSTEM, PERITONEAL, AUTOMATIC DELIVERY

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE·Product code FKX·July 17, 2013

    BD ULTRA-FINE PEN NEEDLE

    FDA Adverse Event
    Malfunction ·BECTON DICKINSON AND CO.·Product code FMI·September 4, 2021

    various polyethylene implants Knees Revision Tibial Tray Systems Oxford Partial Knee Orthopedic Salvage System Vanguard Complete Knee System Vanguard SSK Revision System Biomet Patella Maxim Complete Knee System Biomet Series A Patella Vanguard 360 Revision System Vanguard Deep Dish Rotating Platform Biomet CP Bearings Product Usage: For use in total knee arthroplasty. Limb salvage joint reconstruction. Partial knee replacement.

    FDA Enforcement
    Class II ·Terminated·Zimmer Biomet, Inc.·April 26, 2017

    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