BEUDAMED
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    Plasmage

    FDA UDI
    BRERA MEDICAL INC·00860008655806·Electrosurgical device for soft tissue coagulation

    BREAS MEDICAL, INC.

    FDA registration
    BREAS MEDICAL, INC.·13 products·🇺🇸 United States

    BREAS MEDICAL INC.

    FDA Adverse Event
    Malfunction ·BREAS MEDICAL AB·Product code CBK·October 13, 2021

    HUMAN DESIGN MEDICAL

    FDA UDI
    BREAS MEDICAL, INC.·00859477004123·Ventilator, Non Continuous Respirator

    HUMAN DESIGN MEDICAL

    FDA UDI
    BREAS MEDICAL, INC.·00859477004000·Ventilator, Non Continuous Respirator with Batt...

    HUMAN DESIGN MEDICAL

    FDA UDI
    BREAS MEDICAL, INC.·00859477004017·Ventilator, Non Continuous Respirator

    HUMAN DESIGN MEDICAL

    FDA UDI
    BREAS MEDICAL, INC.·00859477004116·Battery Source for Ventilator, Non Continuous R...

    HUMAN DESIGN MEDICAL

    FDA UDI
    BREAS MEDICAL, INC.·00859477004161·Ventilator, Non Continuous Respirator with Batt...

    Hemoccult II BRAND SENSA elite; MATERIALS AND REAGENTS; Hemoccult II SENSA elite Slides (Test Cares) containing guaiac paper; Hemoccult SENSA Developer-a developing solution containing a stabilized mixture of less than 4.2% hydrogen peroxide, 80% denatured ethyl alcohol and enhancer in an aqueous solution; Applicator Sticks; Patient Screening Kit Dispensing Envelopes with Patient Instructions; Flushable Collection Tissues; Mailing Pouches (for returning completed Test Cares); Hemoccult II SENSA elite Product Instructions; Beckman Coulter, Inc.; 250 S. Kraemer Blvd.; Brea, CA 92821 The Hemoccult II SENSA elite test is a rapid, convenient and qualitative method for detecting fecal occult blood which may be indicative of gastrointestinal disease. It is not a test for colorectal cancer or any other specific diseases. The Hemoccult II SENSA elite test is recommended for professional use as a diagnostic aid during routine physical examinations, for hospital patients to monitor for gastrointestinal bleeding in patients with iron deficiency anemia or recuperating from surgery, peptic ulcer, ulcerative colitis and other conditions, and in screening programs for colorectal cancer when the Patient Instructions are closely followed. Serial fecal specimen analysis is recommended when screening symptomatic patients. The Hemoccult II SENSA elite test and other unmodified guaiac tests are not recommended for use with gastric specimens.

    FDA Enforcement
    Class II ·Terminated·Assuramed·September 25, 2013

    BREAS VIVO 45LS

    FDA Adverse Event
    Injury ·BREAS MEDICAL, INC.·Product code NOU·July 7, 2025

    BREAS VIVO 45LS

    FDA Adverse Event
    Injury ·BREAS MEDICAL, INC.·Product code NOU·July 7, 2025

    BREAS VIVO 45 LS

    FDA Adverse Event
    Injury ·BREAS MEDICAL, INC.·Product code NOU·August 11, 2025

    BREAS VIVO 45LS

    FDA Adverse Event
    Injury ·BREAS MEDICAL, INC.·Product code NOU·July 7, 2025

    BREAS VIVO 45LS

    FDA Adverse Event
    Injury ·BREAS MEDICAL INC.·Product code NOU·July 7, 2025

    VIVO VENTILATOR

    FDA Adverse Event
    Malfunction ·BREAS MEDICAL, INC.·Product code NOU·July 9, 2025

    BREAS VIVO 45LS

    FDA Adverse Event
    Injury ·BREAS MEDICAL, INC.·Product code NOU·July 7, 2025

    BREAS VIVO 45LS

    FDA Adverse Event
    Injury ·BREAS MEDICAL, INC.·Product code NOU·July 7, 2025

    BREAS VIVO 45LS

    FDA Adverse Event
    Injury ·BREAS MEDICAL, INC.·Product code NOU·July 7, 2025

    BREAS VIVO 45 LS HOME HEALTH VENTILATOR

    FDA Adverse Event
    Injury ·BREAS MEDICAL, INC.·Product code NOU·August 5, 2025

    BREAS VIVO 45LS

    FDA Adverse Event
    Injury ·BREAS MEDICAL, INC.·Product code NOU·July 7, 2025