BEUDAMED
    28 results · 24ms · Sources: EU EUDAMED, US FDA

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    iSyncWave

    FDA 510(k)
    FDA Class 2 ·Neurology

    Corneal Trephine

    FDA UDI
    KATENA PRODUCTS, INC.·00841668112496·BARRON VACUUM TREPHINE 7.5MM

    V2 TRIVERSE I-BEAM OSTEOTOME

    FDA UDI
    SIGNATURE ORTHOPAEDICS PTY LTD·09348215127640·

    InSitu Hip System

    FDA UDI
    NEXTSTEP ARTHROPEDIX, LLC·00816127029523·Bipolar Head Assembly, Size 56mm

    HUMAN KAPPA AND LAMBDA FREE KITFOR USE ON THE SPA PLUS ANALYSER

    FDA 510(k)
    FDA Class 2 ·Immunology

    DUET SUTURE ANCHOR

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    OPHTHALMIC FEMTOSECOND LASER

    FDA Adverse Event
    Malfunction ·AMO MANUFACTURING USA, LLC·Product code OOE·February 9, 2021

    WOLVERINE CORONARY CUTTING BALLOON

    FDA Adverse Event
    Injury ·BOSTON SCIENTIFIC CORPORATION·Product code NWX·December 1, 2022

    NC EMERGE

    FDA Adverse Event
    Injury ·BOSTON SCIENTIFIC CORPORATION·Product code LOX·December 1, 2022

    ACCU-CHEK COMFORT CURVE TEST STRIPS

    FDA Adverse Event
    Malfunction ·ROCHE DIAGNOSTICS·Product code LFR·October 31, 2008

    PCS2

    FDA Adverse Event
    Malfunction ·HAEMONETICS CORP.·Product code JJX·August 9, 2011

    PROMOTE PLUS CRT-D

    FDA Adverse Event
    Malfunction ·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code NIK·July 11, 2013

    CATALYS SYSTEM

    FDA Adverse Event
    Malfunction ·AMO MANUFACTURING USA, LLC·Product code OOE·January 11, 2021

    CATALYS SYSTEM

    FDA Adverse Event
    Malfunction ·AMO MANUFACTURING USA, LLC·Product code OOE·January 11, 2021

    FLEXTOME CUTTING BALLOON

    FDA Adverse Event
    Injury ·BOSTON SCIENTIFIC CORPORATION·Product code NWX·December 1, 2022

    WOLVERINE CORONARY CUTTING BALLOON

    FDA Adverse Event
    Injury ·BOSTON SCIENTIFIC CORPORATION·Product code NWX·December 8, 2022

    CATALYS SYSTEM

    FDA Adverse Event
    Malfunction ·AMO MANUFACTURING USA, LLC·Product code OOE·March 5, 2021

    CATALYS SYSTEM

    FDA Adverse Event
    Malfunction ·AMO MANUFACTURING USA, LLC·Product code OOE·March 5, 2021

    CATALYS SYSTEM

    FDA Adverse Event
    Malfunction ·AMO MANUFACTURING USA, LLC·Product code OOE·February 16, 2021

    iNSitu Bipolar Hip System, Bipolar head implant Part ID Description 10-22-0038 Bipolar Head Assembly, Size 38mm 10-22-0040 Bipolar Head Assembly, Size 40mm 10-22-0042 Bipolar Head Assembly, Size 42mm 10-22-0044 Bipolar Head Assembly, Size 44mm 10-22-0046 Bipolar Head Assembly, Size 46mm 10-22-0048 Bipolar Head Assembly, Size 48mm 10-22-0050 Bipolar Head Assembly, Size 50mm 10-22-0052 Bipolar Head Assembly, Size 52mm 10-22-0054 Bipolar Head Assembly, Size 54mm 10-22-0056 Bipolar Head Assembly, Size 56mm 10-22-0058 Bipolar Head Assembly, Size 58mm 10-22-0060 Bipolar Head Assembly, Size 60mm

    FDA Enforcement
    Class II ·Ongoing·Theken Companies LLC·October 29, 2025