BEUDAMED
    11 results · 25ms · Sources: EU EUDAMED, US FDA

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    XprESS Multi-Sinus Dilation System

    FDA 510(k)
    FDA Class 1 ·Ear, Nose, Throat

    OsteoMed

    FDA UDI
    OSTEOMED LLC·00842528127667·2.4 X 34mm Cannulated Headless Screw, T7

    Novo Surgical

    FDA UDI
    NOVO SURGICAL, INC.·G586G1524340·ragnell (kilner) scissors, curved, 9" (22.8 cm)

    BD ORAL/ENTERAL SYRINGE WITH BD UNIVIA CONNECTION

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

    HAWKEYE 4 OPTION FOR DUAL-HEAD VARIABLE ANGLE GAMMA CAMERA

    FDA 510(k)
    FDA Class 2 ·Radiology

    TANDEM T: SLIM INSULIN DELIVERY SYSTEM

    FDA Adverse Event
    Malfunction ·TANDEM DIABETES CARE INC.·Product code LZG·October 6, 2014

    PULSE GEN MODEL 105

    FDA Adverse Event
    Malfunction ·CYBERONICS, INC.·Product code LYJ·June 7, 2013

    OT VERIO IQ METER

    FDA Adverse Event
    Malfunction ·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·October 15, 2015

    Reamer / Irrigator / Aspirator (RIA): RIA Drive Shafts, RIA Tube Assemblies, sterile, RIA Reamer Head, sterile (12.0mm-19.0mm); intended to clear the medullary canal of bone marrow and debris and to effectively size the medullary canal for the acceptance of an intramedullary implant or prosthesis

    FDA Enforcement
    Class II ·Terminated·Synthes, Inc.·July 22, 2015

    Exactech Equinoxe REVERSE SHOULDER,38mm Constrained Humeral Liner: a) +0mm, Item Number 320-38-10, b) +2.5mm, Item Number 320-38-13, Shoulder Arthroplasty

    FDA Enforcement
    Class II ·Ongoing·Exactech, Inc.·April 10, 2024

    Alaris System PC Unit Model 8000, a modular infusion pump and monitoring system

    FDA Enforcement
    Class I ·Terminated·CareFusion 303, Inc.·August 12, 2020