BEUDAMED
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    HT-WEDGE

    FDA 510(k)
    FDA Class 2 ·General Hospital

    MEDI

    FDA UDI
    MEDI MANUFACTURING, INC.·04049772813872·GENUMEDI PRO SILVER SIZE VII

    SURGISTAR

    FDA UDI
    SURGISTAR, INC.·00878799006738·

    ArgenZ Anterior 95x25 #3

    FDA UDI
    ARGEN CORPORATION, THE·D818121287·Dental porcelain/ceramic restoration kit

    Ambler Surgical

    FDA UDI
    AMBLER SURGICAL CORP.·10190660198586·Anterior chamber rycroft cannula, 20 gauge x 6....

    TEPHAFLEX COMPOSITE MESH

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

    TRILLIUM AFFINITY NT CARDIOTOMY VENOUS RESERVOIR, MODELS 540T, 541TT

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    ZEPHYR XL DR

    FDA Adverse Event
    Malfunction ·ST. JUDE MEDICAL, CARDIAC RHYTHM MANAGEMENT DIVISION·Product code DXY·January 13, 2014

    OT VERIO IQ METER

    FDA Adverse Event
    Malfunction ·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·May 20, 2013

    INRATIO2

    FDA Adverse Event
    Malfunction ·ALERE SAN DIEGO, INC.·Product code GJS·May 5, 2011

    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