BEUDAMED
    7 results · 18ms · Sources: EU EUDAMED, US FDA

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    ASTORIA-PACIFIC SPOTCHECK G6PD KIT 50 HR, MODEL 80-3000-13K

    FDA 510(k)
    FDA Class 2 ·Hematology

    HISTO-DISPENSER

    FDA 510(k)
    FDA Class 1 ·Microbiology

    BLACKROCK NEUROPORT BIOPOTENTIAL SIGNAL PROCESSING SYSTEM

    FDA 510(k)
    FDA Class 2 ·Neurology

    SOLYX SIS SYSTEM

    FDA Adverse Event
    Injury ·BOSTON SCIENTIFIC - MARLBOROUGH·Product code FTL·March 6, 2013

    MAXIMO II DR

    FDA Adverse Event
    Injury ·MEDTRONIC MED REL, INC.·Product code LWS·February 15, 2011

    CONCERTO II CRT-D

    FDA Adverse Event
    Injury ·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code NIK·August 8, 2014

    Allura Xper FD10 Product Codes: (1)722010, (2) 722026, (3) 722003; Associated 510(k) numbers: K102005, K130842, K130638, K133292, K141979, K161563, K162859, K033737, K041949;

    FDA Enforcement
    Class II ·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·October 1, 2025