BEUDAMED
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    NIACIN CONTROL DISKS

    FDA 510(k)
    FDA Class 1 ·Microbiology

    Instrument Case

    FDA UDI
    KATENA PRODUCTS, INC.·00841668110973·STERILIZING CASE MEDIUM/SMALL

    MLS, ZERONA-AD

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

    DATASCOPE'S 8FR. ALT B IAB; DATASCOPE'S PROFILE 8FR. ALT B IAB; DATASCOPE'S TRUE SHEATHLESS DL 9.5 FR. IAB; DATASCOPE'S

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    NOVASURE IMPEDANCE CONTROLLED EA SYSTEM

    FDA Adverse Event
    Injury ·HOLOGIC·Product code MNB·January 10, 2013

    PERCLOSE PROGLIDE 6F SUTURE MEDIATED CLOSURE (SMC) SYSTEM

    FDA Adverse Event
    Injury ·AV-REDWOOD CITY·Product code MGB·December 10, 2010

    SYNCHROMED II

    FDA Adverse Event
    Injury ·MDT PUERTO RICO OPERATIONS CO·Product code LKK·July 8, 2014

    ALLURA Xper FD20; System Code: (1) 722006, (2)722012, (3)722028;

    FDA Enforcement
    Class II ·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·April 8, 2026

    Allura Xper FD20; Model Numbers: (1) 722006, (2) 722012, (3) 722028; Associated 510(k)s: K102005, K130638, K130842, K133292, K141979, K162859, K161563;

    FDA Enforcement
    Class II ·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·October 8, 2025