BEUDAMED
    10 results · 21ms · Sources: EU EUDAMED, US FDA

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    Vitrea CT Lung Density Analysis Software

    FDA 510(k)
    FDA Class 2 ·Radiology

    Leg Bag

    FDA UDI
    C. R. Bard, Inc.·00801741050916·Dispoz-A-Bag Leg Bag, Medium (19oz), with Flip-...

    Ophthalmic Speculum

    FDA UDI
    KATENA PRODUCTS, INC.·00841668100264·KATENA DBL-X ASPIRATING SPECULUM K-WIRE

    IMMUNOCAP SPECIFIC IGE ALLERGEN BUNDLE, 12 ALLERGEN COMPONENTS

    FDA 510(k)
    FDA Class 2 ·Immunology

    MODIFICATION TO: USGI SHAPELOCK ENDOSCOPIC GUIDE

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

    DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM

    FDA Adverse Event
    Malfunction ·DEXCOM, INC.·Product code QBJ·June 13, 2025

    G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM

    FDA Adverse Event
    Malfunction ·DEXCOM, INC.·Product code MDS·October 8, 2014

    PULSE-GENERATOR, DUAL CHAMBER, IMPLANTABLE

    FDA Adverse Event
    Malfunction ·MEDTRONIC MILACA, INC.·Product code LWP·June 7, 2013

    COLLEAGUE PRE P1.7

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·July 7, 2011

    BARD DISPOZ-A-BAG Leg Bag with Flip-Flo Valve with Drain Extension, Extension Tube and Latex Straps, 19 oz. Packaged as single unit in thermoformed trays. There are 50 units per case. Product Usage: Vinyl leg bag to be used with male external catheters, Foley catheters, or moth other types of urinary catheters, which are intended for use for bladder management including urine drainage, collection and measurement.

    FDA Enforcement
    Class II ·Terminated·C.R. Bard, Inc.·August 16, 2017