BEUDAMED
    12 results · 23ms · Sources: EU EUDAMED, US FDA

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    LnK Spinal Fixation System /OpenLoc-L Spinal Fixation System, AccelFix Spinal Fixation System

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    Ophthalmic Knife

    FDA UDI
    KATENA PRODUCTS, INC.·00841668113288·STAB KNIFE 22.5 DEGREE (BX/5)

    T:SLIM X2 INSULIN PUMP WITH INTEROPERABLE TECHNOLOGY

    FDA Adverse Event
    Malfunction ·TANDEM DIABETES CARE·Product code QFG·April 14, 2021

    Kyocera Medical Technologies, Inc.

    FDA UDI
    KYOCERA MEDICAL TECHNOLOGIES, INC.·00841523184286·R CR E-CIMA Vitamin E Ultracongruent Tibial Ins...

    Kyocera Medical Technologies, Inc.

    FDA UDI
    KYOCERA MEDICAL TECHNOLOGIES, INC.·00841523184521·R Ultracongruent Tibial Insert Trial Sz B 11mm

    Medical Examination Gloves

    FDA 510(k)
    FDA Class 1 ·General Hospital

    ROCHE DIAGNOSTICS OMNI S ANALYZER

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM

    FDA Adverse Event
    Malfunction ·DEXCOM, INC.·Product code QBJ·August 21, 2025

    HEARTSTART MRX

    FDA Adverse Event
    Malfunction ·PHILIPS MEDICAL SYSTEMS·Product code MKJ·September 17, 2014

    ASR UNI FEMORAL IMPL SIZE 49

    FDA Adverse Event
    Injury ·DEPUY INTERNATIONAL, LTD·Product code KWA·August 18, 2011

    QUANTA SYSTEM S.P.A.

    FDA Adverse Event
    Malfunction ·QUANTA SYSTEM, S.P.A.·Product code GEX·December 21, 2012

    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