BEUDAMED
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    Aptima CMV Quant Assay

    FDA 510(k)
    FDA Class 2 ·Microbiology

    Burr

    FDA UDI
    KATENA PRODUCTS, INC.·00841668113165·DIAMOND BURR 5.0MM DIAMETER DISC

    Bar Phantom

    FDA UDI
    BIODEX MEDICAL SYSTEMS, INC.·00718175009352·Bar Phantom, Rectangular

    INFINION 16

    FDA Adverse Event
    Injury ·BOSTON SCIENTIFIC NEUROMODULATION·Product code LGW·September 11, 2024

    PISCES-SA Standalone ALIF Interbody System

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    DigiLine Direct Print Aligner System

    FDA 510(k)
    FDA Class 2 ·Dental

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    FDA Adverse Event
    MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OYC·November 11, 2014

    UNKNOWN DEPUY ASR ACETABULAR CUP

    FDA Adverse Event
    Injury ·DEPUY INTL., LTD. - 8010379·Product code KWA·July 23, 2013

    DEXCOM G5 MOBILE CONTINUOUS GLUCOSE MONITORING SYSTEM

    FDA Adverse Event
    Malfunction ·DEXCOM, INC.·Product code MDS·November 23, 2015

    Model Number L111, ESSENTIO DR SL MRI Pacemaker

    FDA Enforcement
    Class I ·Ongoing·Boston Scientific Corporation·October 22, 2025