BEUDAMED
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    Implantable Cardioverter Defibrillator (Non-Crt)

    FDA Pre-Market Approval
    FDA Class 3 ·ACE HEADER, END CAP, SIZING SLEEVE, , UPSIZING SLEEVE

    Urocare® Tubing Clear-Vinyl with Nozzle Adapter & Cap 0.28" ID x 60"

    FDA UDI
    UROCARE PRODUCTS, INC.·00792293060617·TUBING, URINE COLLECTION, OSTOMY, CLEAR-VINYL, ...

    Urocare® Tubing Clear-Vinyl with Nozzle Adapter & Cap 0.28" ID x 60"

    FDA UDI
    UROCARE PRODUCTS, INC.·00792293060600·TUBING, URINE COLLECTION, OSTOMY, CLEAR-VINYL, ...

    Urocare® Tubing Clear-Vinyl with Nozzle Adapter & Cap 0.28" ID x 8.5"

    FDA UDI
    UROCARE PRODUCTS, INC.·00792293060853·TUBING, URINE COLLECTION, OSTOMY, CLEAR-VINYL, ...

    Urocare® Tubing Clear-Vinyl with Nozzle Adapter, Cap & Sterile 0.28" ID x 18"

    FDA UDI
    UROCARE PRODUCTS, INC.·00792293060877·TUBING, URINE COLLECTION, OSTOMY, CLEAR-VINYL, ...

    Urocare® Tubing Clear-Vinyl with Nozzle Adapter & Cap 0.28" ID x 18"

    FDA UDI
    UROCARE PRODUCTS, INC.·00792293060860·TUBING, URINE COLLECTION, OSTOMY, CLEAR-VINYL, ...

    LMT-3000

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

    Neurosteer EEG Recorder

    FDA 510(k)
    FDA Class 2 ·Neurology

    LEXUS CERVICAL FIXATION SYSTEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    VENUS LUMBAR INTERVERTEBRAL BODY FUSION CAGE SYSTEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    AnsCare ChitoClot Pad

    FDA 510(k)
    FDA Unclassified ·Unknown

    VENUS SPINAL FIXATION SYSTEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    AnsCare ChitoClot Gauze (prescription use), AnsCare ChitoClot Gauze (over-the-counter use)

    FDA 510(k)
    FDA Unclassified ·Unknown

    COMFORT COUGH

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    LEXUS CERVICAL INTERVERTEBRAL BODY FUSION CAGE SYSTEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    SYNTEC DENTAL IMPLANT

    FDA 510(k)
    FDA Class 2 ·Dental

    Anscare SIMO Negative Pressure Wound Therapy (NPWT) System

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

    FOCUS MIS SYSTEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    VENUS BASIC SPINAL FIXATION SYSTEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    MODIFICATION TO SYNTEC-TAICHUN NON-STERILE BONE PLATE AND SCREW IMPLANTS

    FDA 510(k)
    FDA Class 2 ·Orthopedic