BEUDAMED
    56 results · 63ms · Sources: EU EUDAMED, US FDA

    Get notified when this changes

    We'll email you when new records match this search — new devices, new clearances, certificate changes, or withdrawals.

    OPTI Medical Systems, Inc.

    Manufacturer
    🇺🇸 United States

    OPTI MEDICAL SYSTEMS INC.

    FDA registration
    OPTI MEDICAL SYSTEMS INC.·16 products·🇺🇸 United States

    OPTI Check Control Tri Level

    FDA UDI
    OPTI MEDICAL SYSTEMS, INC.·00894472000107·OPTI Check Controls Tri Level

    B Cassette

    FDA UDI
    OPTI MEDICAL SYSTEMS, INC.·00894472000237·B Cassette Carton

    Comfort Sampler

    FDA UDI
    OPTI MEDICAL SYSTEMS, INC.·00894472000138·Comfort Sampler, Arterial Blood Sampler

    OPTI CCA E Cassette

    FDA UDI
    OPTI MEDICAL SYSTEMS, INC.·00894472000244·OPTI CCA E Cassette

    OPTI Accessory Kit

    FDA UDI
    OPTI MEDICAL SYSTEMS, INC.·00894472000077·OPTI CCA Analyzer accessory kit

    Comfort Sampler, Basic Kit

    FDA UDI
    OPTI MEDICAL SYSTEMS, INC.·00894472000176·Comfort Sampler, Basic Kit

    OPTI CCA E-Cl Cassette

    FDA UDI
    OPTI MEDICAL SYSTEMS, INC.·00894472000268·OPTI CCA E-Cl Cassette

    OPTI CCA E-Glu Cassette

    FDA UDI
    OPTI MEDICAL SYSTEMS, INC.·00894472000275·OPTI CCA E-Glu Cassette

    OPTI CCA TS Accessory Kit

    FDA UDI
    OPTI MEDICAL SYSTEMS, INC.·00894472000145·OPTI CCA TS Accessory Kit

    OPTI Analyzer CCA TS

    FDA UDI
    OPTI MEDICAL SYSTEMS, INC.·00894472000152·OPTI Analyzer CCA TS

    OPTI Check Plus

    FDA UDI
    OPTI MEDICAL SYSTEMS, INC.·00894472000114·OPTI Check Plus Tri-level controls

    E-Ca Cassette Carton

    FDA UDI
    OPTI MEDICAL SYSTEMS, INC.·00894472000251·E-Ca Cassette

    Comfort Sampler Bulk

    FDA UDI
    OPTI MEDICAL SYSTEMS, INC.·00894472000183·Bulk Comfort Sampler

    OPTI LION Cassettes, E-Plus, Model BP7507 (25 per box), OSME TECH critical care. Intended to be used for the measurement of sodium, potassium, chloride, ionized calcium and pH in samples of whole blood, serum and plasma.

    FDA Recall
    Terminated ·OPTI Medical Systems, Inc·Product code CGZ·April 20, 2009

    Model BP7507 OPTI LION E-Plus Cassettes 25 Cassettes with Sample Probes, OPTIMedical Cassettes are consumable used in the OPTI LION Electrolyte Analyzer intended to be used for the measurement of sodium, potassium, chloride, ionized calcium and pH in samples of whole blood, serum, and plasma.

    FDA Recall
    Terminated ·OPTI Medical Systems, Inc·Product code JJE·August 9, 2013

    OPTI LION E-Plus Cassette, Model BP7507, Opti Medical (25 Cassettes with Samples Probes per box). Cassettes are consumables used in the OPTI LION Electrolyte Analyzer intended to be used for the measurement of sodium potassium, chloride, ionized calcium and pH in samples of whole blood, serum and plasma. . Cassettes contain one-time use sensors that are used with the OPTI-LION analyzer to perform in-vitro measurements of electrolytes. OPTI LION E-Plus Cassettes are supplied in boxes of 25 and may only be used with the OPTI LION Electrolyte Analyzer.

    FDA Recall
    Terminated ·OPTI Medical Systems, Inc·Product code CGZ·March 15, 2011

    OPTI LION E-Plus Cassettes, Model BP7507, (25 per box), In Vitro Diagnostic, OPTI Medical Systems, Inc., Roswell, Georgia 30076

    FDA Recall
    Terminated ·Opti Medical Systems Inc·Product code JGS·July 18, 2007

    OPTI SARS-COV-2 RT PCR TEST

    FDA Adverse Event
    Malfunction ·OPTI MEDICAL SYSTEMS, INC.·Product code QJR·May 27, 2021