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

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    FUJIFILM Endoscope Model EB-710P; FUJIFILM Processor EP-8000

    FDA 510(k)
    FDA Class 2 ·Ear, Nose, Throat

    Symmetry Gelpi

    FDA UDI
    ASPEN SURGICAL PRODUCTS, INC.·00887482045299·Symmetry® Retractor, Gelpi, Bent 90°, 6 3/4 in

    Insignia

    FDA UDI
    ALPHATEC SPINE, INC.·00190376264691·4.0mm Fixed Angle, Self Drilling Screw, Dual Le...

    InMode System with the Morpheus8 90 Applicator

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

    Examination gloves-Type A(Latex gloves)

    FDA 510(k)
    FDA Class 1 ·General Hospital

    SPINNING SPIROS CLOSED MALE LUER

    FDA Adverse Event
    Malfunction ·ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V.·Product code FPA·March 21, 2019

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    FDA Adverse Event
    Malfunction ·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OYC·November 11, 2014

    RESTORE RECHARGEABLE NEUROSTIMULATOR

    FDA Adverse Event
    Malfunction ·MDT PUERTO RICO OPERATIONS CO., JUNCOS·Product code LGW·August 24, 2011

    OT PING METER

    FDA Adverse Event
    Malfunction ·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·July 24, 2013

    SPINNING SPIROS® CLOSED MALE LUER

    FDA Adverse Event
    Malfunction ·ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V.·Product code FPA·March 21, 2019

    Presource Procedure Packs containing AAMI Level 3 surgical gowns, Multiple Catalog Numbers Produced Between September 1, 2018 and January 15, 2020

    FDA Enforcement
    Class II ·Terminated·Cardinal Health 200, LLC·February 26, 2020

    Model Number L111, ESSENTIO DR SL MRI Pacemaker

    FDA Enforcement
    Class I ·Ongoing·Boston Scientific Corporation·October 22, 2025