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

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    da Vinci X Surgical System (IS4200), da Vinci Xi Surgical System (IS4000)

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

    XLIF

    FDA UDI
    Nuvasive, Inc.·00887517504074·XLIF Corp Blade, 80mm Lung Retractor Nrw

    REAMER HEAD 8.0mm

    FDA UDI
    ADVANCED ORTHOPAEDIC SOLUTIONS, INC.·00848665000603·

    Ophthalmic Cannula

    FDA UDI
    KATENA PRODUCTS, INC.·00841668113752·GIANNETTI POST CAPS CANNULA

    GALIX PACESTAR

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    CHEMTRUE SINGLE/MULTI-PANEL DRUG SCREEN DIP CARD/ CASSETTE TESTS

    FDA 510(k)
    FDA Class 2 ·Clinical Toxicology

    DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM

    FDA Adverse Event
    Malfunction ·DEXCOM, INC.·Product code QBJ·August 14, 2025

    PARADIGM INSULIN INFUSION PUMP

    FDA Adverse Event
    Malfunction ·MEDTRONIC MINIMED·Product code LZG·November 4, 2014

    EXPRESS (TM) LD VASCULAR

    FDA Adverse Event
    Injury ·BOSTON SCIENTIFIC - GALWAY·Product code FGE·August 25, 2011

    PENTA

    FDA Adverse Event
    Injury ·ST. JUDE MEDICAL - NEUROMODULATION·Product code LGW·July 10, 2013

    LIAISON SARS-COV-2 AG

    FDA Adverse Event
    Malfunction ·DIASORIN ITALIA S.P.A.·Product code QKP·March 19, 2024

    MAKO Integrated Cutting System (MICS) HANDPIECE, Catalog Number 209063

    FDA Enforcement
    Class II ·Ongoing·Howmedica Osteonics Corp.·October 16, 2024

    ASPRIRE Cristalle Mammography System (cleared under K212873) installed with the ASPIRE Cristalle Digital Breast Tomosynthesis (DBT) Option (approved under P160031).

    FDA Enforcement
    Class II ·Ongoing·FUJIFILM Healthcare Americas Corporation·August 6, 2025

    Fortify, Sterile EO, Model #/ Part #: CD1231-40/100029238,100030095, 100041981; CD1231-40Q/100029229, 100030087, 100041982; CD1233-40/100029230, 100029250, 100029259,100031058, 100059778, 100070017; CD1233-40Q/100029260, 100029271, 100029277, 100031104, 100070089; CD1235-40/100029272, 100029282, 100029311, 100031039, 100059779; CD1235-40Q/100029273, 100029295, 100029312, 100030840; CD1241-40/100046351; CD1241-40Q/100046167; CD2231-40/100029274, 100030110, 100041922; CD2231-40Q/100029275, 100030089, 100041923; CD2233-40/100029147, 100029276, 100029313, 100031066, 100037043, 100048759, 100070007; CD2233-40Q/100029148, 100029263, 100029314, 100031067, 100037044, 100059770, 100070068; CD2235-40/100029149, 100029265, 100029283, 100031029, 100059837; CD2235-40Q/100029239, 100029258, 100029284, 100031030, 100066504; CD2241-40/100046148; CD2241-40Q/100046149; CD2299-40/100056952

    FDA Enforcement
    Class II ·Terminated·St Jude Medical Inc.·July 4, 2018