BEUDAMED
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    NewVision SC (tisilfocon A) Scleral Lens; NewVision SC Daily Wear Ortho-K (tisilfocon A) Corneo-Scleral Lens

    FDA 510(k)
    FDA Class 2 ·Ophthalmic

    PQ Autoclave Pouches (5-1/4" x 11") Clear Film

    FDA UDI
    PEARSON DENTAL SUPPLIES, INC.·D724P2309101·Pk. of 200

    Zavation

    FDA UDI
    Zavation LLC·00197157002947·CIF 14x18, 9 deg, -10

    Baby-Cooley Kitzmiler Clamp left 14.5cm shanks curved

    FDA UDI
    Geister Medizintechnik GmbH·04057034063316·Baby-Cooley Kitzmiler Clamp left 14.5cm shanks...

    BOSS Balloon Guide Catheter

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    CLUED UP MULTIPURPOSE SOLUTION- NO RUB

    FDA 510(k)
    FDA Class 2 ·Ophthalmic

    Specials

    FDA UDI
    Seaspine Orthopedics Corporation·10889981302306·Lollipop Trial, Anterior-Angled, 23mm x 9mm x 5...

    ALARIS® EXTENSION SET

    FDA Adverse Event
    Malfunction ·CAREFUSION·Product code FPA·August 29, 2016

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    FDA Adverse Event
    Malfunction ·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OYC·November 6, 2014

    RESERVOIR 3ML

    FDA Adverse Event
    Malfunction ·MEDTRONIC PUERTO RICO OPERATIONS MED-REL·Product code FRN·July 20, 2011

    OT VERIO IQ METER

    FDA Adverse Event
    Malfunction ·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·July 17, 2013

    UNKNOWN SAPIEN 3 VALVE

    FDA Adverse Event
    Injury ·EDWARDS LIFESCIENCES·Product code NPT·June 17, 2024

    The Covera Vascular Covered Stent is a flexible, self-expanding endoprothesis comprised of ePTFE encapsulating a nitinol stent framework. The inner lumen of the covered stent is carbon impregnated.

    FDA Enforcement
    Class II ·Ongoing·Bard Peripheral Vascular Inc·February 15, 2023

    BIOMET StageOne Knee Tibial Cement Spacer Mold, 75 MM, Silicone, Sterile, Item 433175.

    FDA Enforcement
    Class II ·Terminated·Biomet, Inc.·April 15, 2020

    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