BEUDAMED
    14 results · 28ms · Sources: EU EUDAMED, US FDA

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    VALVE, STANDARD MODEL PUDENZE FLUSHING

    FDA 510(k)
    FDA Class 2 ·Neurology

    Cardiovascular Procedure Kit

    FDA UDI
    Terumo Cardiovascular Systems Corporation·00699753527669·

    Ophthalmic Cannula

    FDA UDI
    KATENA PRODUCTS, INC.·00841668110638·COAXIAL IRR-ASP TIP STR W/SILICONE 0.3MM

    Ortho Specialties

    FDA UDI
    Young Innovations, Inc.·00843471186534·Bicuspid Bands, Upper, Size 1

    Ophthalmic Cannula

    FDA UDI
    KATENA PRODUCTS, INC.·00841668110645·COAXIAL IRR-ASP TIP STR W/SILICONE 0.4MM

    Noxilizer Surgical Ruler

    FDA 510(k)
    FDA Class 1 ·General, Plastic Surgery

    IMPLANTIUM II

    FDA 510(k)
    FDA Class 2 ·Dental

    PINNACLE MTL INS NEUT40IDX56OD

    FDA Adverse Event
    Injury ·DEPUY ORTHOPAEDICS, INC. 1818910·Product code KWA·September 17, 2013

    OT VERIO IQ METER

    FDA Adverse Event
    Malfunction ·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·April 21, 2014

    GYNECARE MORCELLEX* TISSUE MORCELLATOR

    FDA Adverse Event
    Malfunction ·ETHICON, INC.·Product code HET·September 26, 2012

    SYNCHROMED II

    FDA Adverse Event
    Injury ·MEDTRONIC NEUROMODULATION·Product code LKK·July 15, 2010

    ultraView Universal Alkaline Phosphatase Red Detection Kit, Catalog Number 05269814001, model 760-501 Immunohistochemistry (IHC) for in vitro diagnostic use.

    FDA Recall
    Terminated ·Ventana Medical Systems Inc·Product code NJT·August 2, 2018

    ultraView Universal Alkaline Phosphatase Red Detection Kit, Catalog Number 05269814001, model 760-501 Immunohistochemistry (IHC) for in vitro diagnostic use.

    FDA Enforcement
    Class I ·Terminated·Ventana Medical Systems Inc·September 26, 2018

    GE Healthcare, Compact Airway Modules E-CO, E-COV, E-COVX, E-CAiO, E-CAiOV and E-CAiOVX. The Datex-Ohmeda S/5MT Compact Airway Module, E-CAiOVX family is used for monitoring hospital patients respiration, ventilation, and gas exchange status.

    FDA Enforcement
    Class II ·Terminated·GE Healthcare, LLC·June 25, 2014