BEUDAMED
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    MAVERICK¿ Measurement Module Spectrometer PN 820-01367 (originally part of a kit PN 820-01519) Finished Goods PN 820-01496

    FDA Enforcement
    Class II ·Ongoing·REPLIGEN CORPORATION·January 21, 2026

    Custom procedural convenience kits and trays, cardiac, labeled as: a) HEART CATHETERIZATION TRAY, kit number JRHC45G; b) TAVR PACK, kit number LLTV10; c) CATH PED LF SJH, kit number SJCA21F; d) CATH HEART ADL LF SJH, kit number SJCH22F; e) INT RAD PORTS-LF - 206060, kit number UDIR58AL

    FDA Enforcement
    Class II ·Ongoing·American Contract Systems, Inc.·February 7, 2024

    Smaxel Fractional CO2 Laser, a Class IV medical laser system.

    FDA Enforcement
    Class II ·Ongoing·IDS LTD·January 15, 2025