BEUDAMED
    16 results · 19ms · Sources: EU EUDAMED, US FDA

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    VASCULAR ASSIST

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    Implant Prosthetics

    FDA UDI
    Preat Corporation·00842092102558·Astra®-compatible Aqua 3.5/4.0mm 30° Multi-Unit...

    artVeneer life

    FDA UDI
    Merz Dental GmbH·D7092002186·artVeneer life upper posteriors, S, BL3

    SCANLAN®

    FDA UDI
    SCANLAN INTERNATIONAL INC·00846159007886·Vascular Clamp with 12 mm Hausmann Jaw

    ORTHO ELISA BAR CODE READER II

    FDA Adverse Event
    Other ·INTERMEC CORP./GREENBROOK CORPORATE CENTER·Product code LRH·May 24, 2000

    SURGITEK MAMMARY PROSTHESIS

    FDA Adverse Event
    MEDICAL ENGINEERING CORP.·Product code FTR·May 24, 1994

    MAMMARY PROSTHESIS

    FDA Adverse Event
    MENTOR CORP.·Product code FTR·May 24, 1994

    ETHANOL-L3K ASSAY, MODELS 273-30, 273-17, 273-10

    FDA 510(k)
    FDA Class 2 ·Clinical Toxicology

    DATEX-OHMEDA INOVENT DELIVERY SYSTEM

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    LINOX SMART SD 65/18

    FDA Adverse Event
    Malfunction ·BIOTRONIK SE & CO. KG·Product code NVY·March 13, 2013

    PROPEX

    FDA Adverse Event
    Malfunction ·DENTSPLY MAILLEFER·Product code LQY·February 4, 2011

    BIPOL LEAD MODEL 300

    FDA Adverse Event
    Malfunction ·CYBERONICS, INC.·Product code LYJ·August 12, 2014

    QUICK SET PARADIGM

    FDA Adverse Event
    Malfunction ·UNOMEDICAL A/S·Product code FPA·June 24, 2024

    Smiths Medical, Medfusion¿ Syringe Infusion Pump, Model 4000, Software Version V1.0 & V1.1, Reorder Numbers 4000-0100-50, 4000-0100-95, 4000-0101-50, 4000-0101-51, and 4000-0101-78. Designed for use in care areas for the administration of fluids requiring precisely controlled infusion rates.

    FDA Enforcement
    Class I ·Terminated·Smiths Medical ASD, Inc.·August 8, 2012

    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