BEUDAMED
    13 results · 26ms · Sources: EU EUDAMED, US FDA

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    MOSQUITO

    FDA 510(k)
    FDA Class 1 ·Anesthesiology

    NA

    FDA UDI
    KEY SURGICAL, INC.·00849771048213·K-Wire and Steinmann Pin Dispensers, .045-inch...

    KMEDIC

    FDA UDI
    TELEFLEX INCORPORATED·24026704292312·DISP K-WIRE FOR .045" (1.1MM) 12.25"

    K-Wire and Steinmann Pin Dispensers

    FDA UDI
    KEY SURGICAL, INC.·00849771012030·K-Wire and Steinmann Pin Dispensers, .045-inch...

    APEX Knee System

    FDA UDI
    Omni Life Science, Inc.·00841690189985·Slot Captured Stylus, standard

    Symmetry Surgical

    FDA UDI
    ASPEN SURGICAL PRODUCTS, INC.·00887482125472·Symmetry® Retractor, Humeral Head, 18.0 mm Blad...

    REDSENSE

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

    Revolution ACT

    FDA 510(k)
    FDA Class 2 ·Radiology

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    FDA Adverse Event
    Malfunction ·ANIMAS CORPORATION·Product code LZG·April 24, 2014

    OT ULTRALINK METER

    FDA Adverse Event
    Malfunction ·LIFESCAN INC.·Product code NBW·October 3, 2012

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    FDA Adverse Event
    Malfunction ·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OYC·May 14, 2015

    Model 055: Thermophore Classic, Professional Quality, Deep-Heat Therapy, Model 055 Large 14' x 27", Model 056: Thermophore Classic, Professional Quality Deep-Heat Therapy, Model 056 Medium 14" x 14", Model 077: Thermophore Classic Professional Quality Deep-Heat Therapy, Model 077 Petite 4"x 17",Model 095: Thermophore Classic, Professional Quality Deep-Heat Therapy, Model 095 Large 14" x 27 Model 096: Thermophore Classic, Professional Quality Deep-Heat therapy Model 096, Medium, 14" x 14" Model 097: Thermophore Classic, Professional quality Deep-Heat Therapy, Model 097 , Petite, 4" x 17", Model 255: Thermophore Classic Plus, Professional Quality Deep-Heat Therapy, Model 255 Large,14" x 27", Model 256: Thermophore Classic Plus Professional Quality Deep-Heat Therapy, Model 256, Medium, 14" X 14 Model 277: Thermophore Classic Plus Professional Quality Deep-Heat Therapy, Model 277, Petite , 4" x 17" Used for the temporary relief of joint and muscle pain.

    FDA Enforcement
    Class II ·Terminated·Battle Creek Equipment Co.·November 9, 2016

    MR Coils The MR Coil is intended to be used in conjunction with a Magnetic Resonance Scanner to produce diagnostic images of the anatomy of interest that can be interpreted by a trained physician.

    FDA Enforcement
    Class III ·Terminated·Invivo Corporation·October 28, 2020