BEUDAMED
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    P20 Elite Series Digital Color Doppler Ultrasound System

    FDA 510(k)
    FDA Class 2 ·Radiology

    Adler Instrument Company

    FDA UDI
    Adler, Inc.·00810123202300·TC MAYO-HEGAR NH 7-1/4

    Stryker

    FDA UDI
    Provision·B504OM42211400900·

    Stryker

    FDA UDI
    Provision·00810041636539·

    NA

    FDA UDI
    STERILMED, INC.·10888551030823·SAW BLADE SAGITTAL DUAL-CUT NO OFFSET

    NA

    FDA UDI
    STRYKER CORPORATION·07613154169818·Dual Cut Sagittal Blade, No Offset

    FOSSA EXPANDING DOUBLE PIGTAIL URETERAL STENT

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

    PROLYTE ELECTROLYTE ANALYZER

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    AMPLATZ ULTRA STIFF PTFE FIXED CORE WIRE GUIDE

    FDA Adverse Event
    Malfunction ·COOK INC·Product code OCY·December 7, 2018

    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

    UNKNOWN OPTEASE VENA CAVA FILTER

    FDA Adverse Event
    Injury ·CORDIS CORPORATION·Product code DTK·November 3, 2014

    AU2703-03E CLINICAL CHEMISTRY ANALYZER.

    FDA Adverse Event
    Malfunction ·BECKMAN COULTER MISHIMA K.K.·Product code JJE·August 23, 2011

    URETEX SUP PUBOURETHRAL SLING

    FDA Adverse Event
    Injury ·SOFRADIM PRODUCTION·Product code FTL·May 17, 2013

    XP-CR Tibial Tray - Interlok 67mm Item # 195271

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

    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

    The Merlin PCS 3650 programmer Model 3330 The Merlin PCS programmer model 3650 is a portable, dedicated programming system which operates using the Merlin PCS Model 3330 software and is designed to interrogate, program, display data from, and test Abbott Medical implantable devices and leads.

    FDA Enforcement
    Class II ·Ongoing·Abbott Medical·January 1, 2025