BEUDAMED
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    MA012 Aluminum wheelchair, MS019 steel wheelchair

    FDA 510(k)
    FDA Class 1 ·Physical Medicine

    BD BBL™ Taxo™ Novobiocin

    FDA UDI
    BECTON, DICKINSON AND COMPANY·00382902317500·BD BBL™ Taxo™ Differentiation Discs Novobiocin

    Ophthalmic Spatula

    FDA UDI
    KATENA PRODUCTS, INC.·00841668102152·BARRAQUER SABLE BRUSH

    LOCKING SCREW, FULLY THREADED 5X45 MM

    FDA Adverse Event
    Malfunction ·STRYKER OSTEOSYNTHESIS KIEL·Product code HSB·October 30, 2009

    Immunalysis Corporation

    FDA UDI
    IMMUNALYSIS CORPORATION·00840937106952·Immunalysis Corporation Carisoprodol Conjugate ...

    Infinion™ CX

    FDA UDI
    BOSTON SCIENTIFIC NEUROMODULATION CORPORATION·M365SC2317500·Infinion CX, 50cm 16 Contact Lead Kit

    Infinion™ CX

    FDA UDI
    BOSTON SCIENTIFIC NEUROMODULATION CORPORATION·08714729861614·50cm 16 Contact Lead Kit

    SAFESKIN* BLUE ZONE POWDER-FREE VINYL EXAM GLOVE

    FDA 510(k)
    FDA Class 1 ·General Hospital

    AUTOSURE HT BLOOD GLUCOSE MONITORING SYSTEM

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    VA LOCKSCR 2.7 HEAD 2.4 SELF-TAP L10 TA

    FDA Adverse Event
    Malfunction ·OBERDORF : SYNTHES PRODUKTIONS GMBH·Product code HWC·December 15, 2017

    SYRINGE 5ML SALINE FILL

    FDA Adverse Event
    Malfunction ·BD MEDICAL (BD WEST) MEDICAL SURGICAL·Product code NGT·June 17, 2021

    COLLEAGUE

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

    HEARTSTART MRX

    FDA Adverse Event
    Malfunction ·PHILIPS MEDICAL SYSTEMS·Product code MKJ·October 14, 2014

    LIGACLIP** ENDOSCOPIC CLIP APPLIER

    FDA Adverse Event
    Malfunction ·ETHICON ENDO-SURGERY, LLC.·Product code FZP·July 17, 2013

    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