BEUDAMED
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    Combo Electrotherapy Device

    FDA 510(k)
    FDA Class 2 ·Physical Medicine

    Split Cath®

    FDA UDI
    Medical Components, Inc.·00884908089288·14F X 40CM Split Cath® CATHETER SET (CUFF 35CM ...

    LoFric® Hydro-Kit™

    FDA UDI
    Wellspect AB·07392532142680·Single Use Urinary Catheter LoFric Hydro-Kit Ne...

    Regatta Lateral System

    FDA UDI
    Seaspine Orthopedics Corporation·10889981159054·Lateral Implant, 23mm x 14mm x 40mm, 10 Deg

    Regatta Lateral System

    FDA UDI
    Seaspine Orthopedics Corporation·10889981159047·Lateral Implant, 23mm x 14mm x 40mm, 0 Deg

    SMART CO2 (SMART US 20D, SMART CLINIC) SURGICAL LASER

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

    POWDER FREE NITRILE PATIENT EXAMINATION GLOVES, BLUE

    FDA 510(k)
    FDA Class 1 ·General Hospital

    TENDRIL STS

    FDA Adverse Event
    Malfunction ·ST. JUDE MEDICAL, INC., CRMD·Product code NVN·November 6, 2014

    AGILENT INFO CENTER

    FDA Adverse Event
    Death ·PHILIPS HEALTHCARE - ANDOVER·Product code MHX·August 26, 2011

    LAMITRODE 44

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

    CNS-6801A

    FDA Adverse Event
    Malfunction ·NIHON KOHDEN CORPORATION·Product code MHX·November 20, 2019

    CIVCO Needle Guide Starter Kit, Reusable non-sterile bracket with Infiniti Plus (12, 14, 16, 18GA) needle guides, Rx ONLY. REFs 674-030, 674-030-T, 674-031, 674-031-T, 674-035, 674-036, 674-044, 674-052, 674-059, 674-061. Large Gauge Infiniti Plus Needle Guides, used in needle-guided (or catheter) procedures with diagnostic ultrasound transducers.

    FDA Enforcement
    Class II ·Terminated·Civco Medical Instruments Co. Inc.·November 25, 2015

    Revogene, Catalog no. 610210. IVD test instrument

    FDA Enforcement
    Class II ·Ongoing·Meridian Bioscience Inc·August 3, 2022

    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