BEUDAMED
    17 results · 27ms · Sources: EU EUDAMED, US FDA

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    DEPROTEINIZING & CLEANING SOLUTION

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    Ophthalmic Spatula

    FDA UDI
    KATENA PRODUCTS, INC.·00841668102916·CLAYMAN NUCLEUS ROTATOR

    Battle Creek Equipment

    FDA registration
    Battle Creek Equipment·3 products·🇺🇸 United States

    UniTip High Resolution Catheter

    FDA UDI
    Unisensor AG·07640172971109·

    MILLENNIUM III 4 CHANNEL NEUROVASCULAR COIL

    FDA 510(k)
    FDA Class 2 ·Radiology

    RUSCH SAFETY SILK SERIES ORAL/NASAL TRACHEAL TUBE

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    1832415-2017-08675

    FDA Adverse Event
    Injury ·October 9, 2018

    1832415-2018-09738

    FDA Adverse Event
    Malfunction ·October 28, 2018

    1832415-2018-09678

    FDA Adverse Event
    Malfunction ·October 4, 2018

    1832415-2017-09097

    FDA Adverse Event
    Malfunction ·April 5, 2018

    2008K HEMODIALYSIS SYS OLC/DIASAFE PLUS

    FDA Adverse Event
    Malfunction ·FRESENIUS MEDICAL CARE NORTH AMERICA·Product code KDI·March 27, 2014

    ION¿

    FDA Adverse Event
    Injury ·BOSTON SCIENTIFIC - MAPLE GROVE·Product code NIQ·November 14, 2012

    OT ULTRALINK METER

    FDA Adverse Event
    Malfunction ·LIFESCAN, INC.·Product code MDS·September 13, 2010

    LIFEPAK CR(R) PLUS DEFIBRILLATOR

    FDA Adverse Event
    Malfunction ·PHYSIO-CONTROL, INC·Product code MKJ·December 21, 2017

    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

    ALLURA Xper FD20; System Code: (1) 722006, (2)722012, (3)722028;

    FDA Enforcement
    Class II ·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·April 8, 2026

    Allura Xper FD20; Model Numbers: (1) 722006, (2) 722012, (3) 722028; Associated 510(k)s: K102005, K130638, K130842, K133292, K141979, K162859, K161563;

    FDA Enforcement
    Class II ·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·October 8, 2025