BEUDAMED
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    THE PARTNER SPECTROPHOTOMETER

    FDA 510(k)
    FDA Class 1 ·Clinical Chemistry

    CONDUCTIVE SHOE COVERS

    FDA 510(k)
    FDA Class 1 ·General, Plastic Surgery

    FORSURE ONE STEP DIP & READ (X) DRUG SCREEN TEST

    FDA 510(k)
    FDA Class 2 ·Clinical Toxicology

    CAPSUREFIX

    FDA Adverse Event
    Injury ·MPRI·Product code NVN·June 10, 2014

    TENSION FREE VAGINAL TAPE

    FDA Adverse Event
    Injury ·ETHICON INC·Product code FTL·December 7, 2012

    ENVISTA INTRAOCULAR LENS

    FDA Adverse Event
    Malfunction ·BAUSCH & LOMB·Product code HQL·June 19, 2015

    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

    OEC 6800 Miniview, Image-intensified fluoroscopic x-ray system used during diagnostic, surgical and interventional procedures. Designed to provide the physician with general fluoroscopic visualization of the patient including but not limited to surgical orthopedic and extremity imagine. The device is not intended for whole-body pediatric imaging.

    FDA Enforcement
    Class I ·Terminated·GE OEC Medical Systems, Inc·August 1, 2012