BEUDAMED
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    TYSHAK MINI PEDIATRIC PTV CATHETER, MODEL 107

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    Vital Signs

    FDA UDI
    Carefusion Finland 320 Oy·10885403269172·300-Series ECG Leadwire, Individual Replacement...

    Ophthalmic Cannula

    FDA UDI
    KATENA PRODUCTS, INC.·00841668114278·CHAMBER MAINTAINER 20GA (PK/10)

    Merit Medical®

    FDA UDI
    Merit Medical Systems, Inc.·00884450551950·

    MPT 24 AND VITAL VIEW 24

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    MEDICAL IMAGE MERGE (MIM)

    FDA 510(k)
    FDA Class 2 ·Radiology

    GYRUS UTERINE MANIPULATOR

    FDA Adverse Event
    Injury ·OLYMPUS CORPORATION OF THE AMERICAS·Product code LKF·March 12, 2024

    AUTOSOFT XC

    FDA Adverse Event
    Malfunction ·UNOMEDICAL A/S·Product code FPA·July 13, 2024

    OT VERIO IQ METER

    FDA Adverse Event
    Malfunction ·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·March 14, 2013

    HOMECHOICE PRO

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - LARGO·Product code FKX·February 28, 2011

    PERIPHERALLY INSERTED CENTRAL VENOUS CATHETER

    FDA Adverse Event
    Injury ·COOK INCORPORATED·Product code LJS·February 27, 2008

    AUTOSOFT XC

    FDA Adverse Event
    Malfunction ·UNOMEDICAL A/S·Product code FPA·June 16, 2024

    smiths medical PORTEX Tracheal Tube Exchange Guide, 10Ch x 70cm, REF 14-504-76

    FDA Enforcement
    Class II ·Ongoing·Smiths Medical ASD, Inc.·December 4, 2024

    1202 Flex Focus Ultrasound System, cart models UA1214 and UA1814, used with: Flex Focus 200, Flex Focus 300, Flex Focus 400, Flex Focus 500, Flex Focus 700, Flex Focus 800; System, Imaging, Pulsed Doppler, Ultrasonic

    FDA Enforcement
    Class II ·Ongoing·B-K Medical A/S·November 12, 2025

    Quadra Assura, Model No. CD3265-40, CD3265-40Q, CD3365-40C, CD3365-40Q. Quadra Assura MP, Model No. CD3269-40, CD3269-40Q, CD3369-40C. Fortify and Fortify Assura implantable cardioverter defibrillators (ICDS) are intended to provided ventricular anti-tachycardia pacing and ventricular defibrillation for automated treatment of life threatening ventricular arrhythmias. The devices may also be programmed to provide single or dual chamber bradycardia pacing. Unify and Unify Assura cardiac resynchronization therapy defibrillators (CRTDs) are intended to provide ventricular anti-tachycardia pacing and ventricular defibrillation for automated treatment of life-threatening ventricular arrhythmias. The devices may also be programmed to provide single or dual chamber bradycardia pacing, in additional to cardiac resynchronization therapy via left ventricular pacing

    FDA Enforcement
    Class I ·Terminated·St Jude Medical Inc.·November 2, 2016