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    DIOPSYS INC.

    FDA registration
    DIOPSYS INC.·1 product·🇺🇸 United States

    Diopsys®

    FDA UDI
    DIOPSYS, INC.·00850514007084·NOVA ARGOS Vision Testing System

    Diopsys®

    FDA UDI
    DIOPSYS, INC.·00850514007039·Disposable Hypoallergenic EEG Electrodes, Pouch...

    Diopsys®

    FDA UDI
    DIOPSYS, INC.·00850514007046·ERG Lid Electrodes, Pouch

    Diopsys®

    FDA UDI
    DIOPSYS, INC.·00850514007077·NOVA Vision Testing System

    Diopsys®

    FDA UDI
    DIOPSYS, INC.·00850514007107·Ganzfeld Dome

    Diopsys®

    FDA UDI
    DIOPSYS, INC.·00850514007091·NOVA Software

    Diopsys®

    FDA UDI
    DIOPSYS, INC.·20850514007033·Disposable Hypoallergenic EEG Electrodes, Case/600

    Diopsys®

    FDA UDI
    DIOPSYS, INC.·10850514007050·ERG Lid Electrodes, Case

    Diopsys®

    FDA UDI
    DIOPSYS, INC.·00850514007015·Single Channel EEG Filter/Amplifier Module

    Diopsys®

    FDA UDI
    DIOPSYS, INC.·00850514007053·ERG Lid Electrodes, Box

    Diopsys®

    FDA UDI
    DIOPSYS, INC.·00850514007008·Braided ERG Lead Wire Set, Bag

    Diopsys®

    FDA UDI
    DIOPSYS, INC.·10850514007036·Disposable Hypoallergenic EEG Electrodes, Case/300

    Diopsys®

    FDA UDI
    DIOPSYS, INC.·00850514007022·Braided EEG Snap Lead Wire Set, Bag

    Diopsys Inc., Enfant Pediatric VEP Vision Testing System, Input: 120 Vac, 60Hz/2.5A IEC 60601-1 Class I, Type BF.

    FDA Recall
    Terminated ·Diopsys, Inc.·Product code GWE·April 2, 2007

    The Enfant Evoked Response Photic Stimulator. The Enfant A Pediatric Vision Testing Device, Manufactured by Diopsys, Inc., 355 Main St., Metuchen, NJ 08840. Each medical device unit is assembled and contains an 18 inch flat panel vision stimulator panel, a 17 inch flat panel operator monitor, a 2.25 inch thermal printer, a mobile point of care cart, medical grade battery back-up, speaker, a CPU with floppy and CD drives, a camera and an isolation transformer.

    FDA Recall
    Terminated ·Diopsys Inc·Product code GWE·September 15, 2004

    BIOPSY SCIENCES, INC., HYDROMARK BREAST BIOPSY SITE MARKER

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

    N,I.T., INC. AUTOMATIC CUTTING BIOPSY NEEDLE

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology

    ORION MEDICAL INC. DISPOSABLE BRAIN BIOPSY NEEDLE FOR STEROTACTIC GUIDED BIOPSY

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology

    BIOPSY SCIENCES, INC. HYDROMARK BREST BIOSY SITE MARKER

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