BEUDAMED
    15 results · 18ms · Sources: EU EUDAMED, US FDA

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    WUJIN #3 TIBIAL NAIL

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    Disposable Sensor

    FDA UDI
    Honeywell Healthcare Solutions GmbH·04036616010214·Disposable Sensor DP-2203-2 Nihon Kohden US

    Merit Medical®

    FDA UDI
    Merit Medical Systems, Inc.·00884450180822·

    Alex TriVantage

    FDA UDI
    Candela Corporation·00817495020297·Pulsed Laser

    FLO ASSISTANT, MODEL 4-250-00

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology

    RIGID GAS PERMEABLE CONTACT LENS

    FDA 510(k)
    FDA Class 2 ·Ophthalmic

    UNKNOWN IMPLANTABLE NEUROSTIMULATOR

    FDA Adverse Event
    Injury ·MEDTRONIC NEUROMODULATION·Product code LGW·March 13, 2013

    OCTRODE PERCUTANEOUS LEAD

    FDA Adverse Event
    Malfunction ·ST. JUDE MEDICAL - NEUROMODULATION·Product code LGW·January 27, 2011

    DEEP BRAIN STIMULATION LEAD

    FDA Adverse Event
    Injury ·MEDTRONIC NEUROMODULATION·Product code MHY·February 22, 2008

    THERAKOS XTS PHOTOPHERESIS SYSTEM

    FDA Adverse Event
    Malfunction ·THERAKOS INC.·Product code LNR·September 1, 2015

    SIGMA SPECTRUM Infusion Pump with Master Drug Library component (SHARP LCD screen, 55074-2 revision B) Product Usage: Intended to be used as a visual aid during the controlled administration of intravenous fluids. These fluids may include pharmaceutical drugs, blood, blood products and mixtures of required patient therapy.

    FDA Enforcement
    Class II ·Terminated·Baxter Healthcare Corp.·November 20, 2013

    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

    Ultrasound System 1300, bkSpecto w/battery; Model No. 1300-21 or 1300-S1; System, Imaging, Pulsed Doppler, Ultrasonic

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

    Boston Scientific/Cameron Health SQ-RX Model 1010 subcutaneous pulse generators. The S-ICD System is intended to provide therapy for the treatment of life-threatening ventricular tachyarrhythmias.

    FDA Enforcement
    Class II ·Terminated·Boston Scientific CRM Corp·March 27, 2013

    Medfusion Syringe Pump Model: Model 4000-0100-50, Model 4000-0101-249, Model 4000-0101-50, Model 4000-0101-51, Model 4000-0101-78, Model 4000-0105-249, Model 4000-0105-51, Model 4000-0105-78, Model 4000-0106-00, Model 4000-0106-01, Model 4000-0106-231

    FDA Enforcement
    Class I ·Ongoing·Smiths Medical ASD Inc.·June 29, 2022