BEUDAMED
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    Alinity c Tricyclic Antidepressants Reagent Kit

    FDA 510(k)
    FDA Class 2 ·Clinical Toxicology

    OIC Pedicle Screw System

    FDA UDI
    ORTHOPAEDIC IMPLANT COMPANY, THE·M69622310200·ROD BENDER

    Portex

    FDA UDI
    ICU MEDICAL, INC.·00351688053117·

    OsteoMed

    FDA UDI
    OSTEOMED LLC·00845694021784·FPS 2.0mm Driver Stem

    Curette

    FDA UDI
    KATENA PRODUCTS, INC.·00841668102053·MEYERHOEFER CURETTE #2

    SYRINGE 10ML REG PR SALINE 10ML FILL

    FDA Adverse Event
    Malfunction ·BD MEDICAL (BD WEST) MEDICAL SURGICAL·Product code NGT·November 21, 2019

    RZ Medizintechnik GmbH

    FDA UDI
    RZ-Medizintechnik GmbH·04049197122504·Capener Osteotome curved...

    TEMPERATURE SENSOR CATHETER

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

    FLEXISKIN LATEX EXAMINATION GLOVES, POWDERED, NON STERILE

    FDA 510(k)
    FDA Class 1 ·General Hospital

    INFINION 16

    FDA Adverse Event
    Injury ·BOSTON SCIENTIFIC NEUROMODULATION·Product code LGW·April 3, 2024

    AGOGE PEDICLE SCREW SYSTEM

    FDA Adverse Event
    Malfunction ·ROYAL OAK MEDICAL DEVICES·Product code NKB·October 5, 2012

    global Medium, Model Numbers LGGG-020 (20mL bottle), LGGG-050 (50mL bottle), LGGG-100 (100mL bottle). Intended use: Culture of human embryos from zygote to blastocyst, embryo transfer.

    FDA Enforcement
    Class II ·Ongoing·CooperSurgical, Inc.·February 21, 2024

    HEARTSTRING II PROXIMAL SEAL SYSTEM

    FDA Adverse Event
    Malfunction ·GUIDANT CARDIAC SURGERY·Product code DXC·October 28, 2008

    COLLEAGUE

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·September 1, 2011

    EON MINI

    FDA Adverse Event
    Malfunction ·ST JUDE MEDICAL - NEUROMODULATION·Product code LGW·July 12, 2013

    BioGX SARS-CoV-2 Reagents for BD MAX System Catalog number (REF) 444213. In vitro diagnostic. SARS-CoV-2 Reagents is a real-time RT-PCR test intended for the qualitative detection of nucleic acid from the SARS-CoV-2 in nasopharyngeal, nasal, mid-turbinate, and oropharyngeal swab specimens, nasopharyngeal wash/aspirate or nasal aspirates obtained from individuals suspected of COVID-19 by their healthcare provider.

    FDA Enforcement
    Class II ·Terminated·Becton Dickinson & Co.·February 17, 2021

    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