BEUDAMED
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    MONOJECT STERILE 6CC SYRINGE W/ & WO/ NEEDLES

    FDA 510(k)
    FDA Class 2 ·General Hospital

    Mobility Scooter (T5)

    FDA 510(k)
    FDA Class 2 ·Physical Medicine

    MODEL 3003 UNIPOLAR DEMAND CARDIAC GEN.

    FDA 510(k)
    FDA Class 3 ·Cardiovascular

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    FDA Adverse Event
    Malfunction ·ANIMAS CORPORATION·Product code LZG·June 5, 2014

    SYBRONPRO XRT

    FDA Adverse Event
    Injury ·EBI INC.·Product code DZE·October 4, 2010

    HEARTSINE SAMARITAN 300P AND PAD PAK

    FDA Adverse Event
    Malfunction ·HEARTSINE TECHNOLOGIES, LTD·Product code MKJ·November 26, 2012

    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