BEUDAMED
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    Willow Generation 3 Breast Pump

    FDA 510(k)
    FDA Class 2 ·Obstetrics/Gynecology

    ISOLA

    FDA UDI
    DEPUY SPINE, LLC·10705034005119·ISOLA SPINE SYSTEM MCC PLATE 50-70mm

    GYRUS ACMI, INC

    FDA UDI
    Gyrus ACMI, LLC·00821925028371·ENDOSCOPIC SINUS SURGERY INSTRUMENT TRAY NO. 1 ...

    N/A

    FDA UDI
    BIOMET MICROFIXATION, INC·00841036035716·

    ELMED INCORPORATED

    FDA UDI
    ELMED INCORPORATED·00198506086021·SPATULA OSTEOTOME, 3.7MM, 14CM, 5-1/2”

    NEUROVISION MEDICAL MOTION SENSOR

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    BLUE LINE ULTRA SUCTIONAID TRACHEOSTOMY TUBE

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    FLO-GARD 6201 VOLUMETRIC INFUSION PUMP

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE·Product code FRN·November 17, 2008

    UNKNOWN SPINAL CORD STIMULATOR

    FDA Adverse Event
    Injury ·MEDTRONIC EUROPE SARL·Product code LGW·August 12, 2011

    LARGE NEEDLE DRIVER INSTRUMENT

    FDA Adverse Event
    Malfunction ·INTUITIVE SURGICAL,INC.·Product code NAY·July 16, 2013

    CODMAN Disposable Perforator, 14mm. Cranial perforator.

    FDA Enforcement
    Class I ·Ongoing·Integra LifeSciences Corp. (NeuroSciences)·May 14, 2025

    TRULIANT Knee System including TRULIANT Tibial Inserts, also labeled as the following: a. TRULIANT CR Tibial Inserts; b. TRULIANT CR Slope + Tibial Inserts; c. TRULIANT CR Slope ++ Tibial Inserts; d. TRULIANT CRC Tibial Inserts; e. TRULIANT PS Tibial Inserts; f. TRULIANT PSC Tibial Inserts. NOTE: Information reflects Exactech recall expansion initiated on 02/07/2022.

    FDA Enforcement
    Class II ·Ongoing·Exactech, Inc.·October 13, 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