BEUDAMED
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    Gravitiq X, LLC

    Manufacturer
    🇺🇸 United States

    GRAVITIQ VI LLC

    Manufacturer
    🇺🇸 United States

    Gravitiq VII, LLC

    Manufacturer
    🇺🇸 United States

    Gravitiq IV, LLC

    Manufacturer
    🇺🇸 United States

    GRAVITIQ LLC

    FDA registration
    GRAVITIQ LLC·18 products·🇺🇸 United States

    CERT3GLOBAL, UNIPESSOAL, LDA.

    Authorized representative
    🇵🇹 Portugal·13 Manufacturers·69 Devices

    ZIPPIE ZONE

    FDA Adverse Event
    Injury ·SUNRISE MEDICAL (US) LLC.·Product code IOR·March 29, 2012

    MAGNUS OR-TABLE COOLUMN

    FDA Adverse Event
    Malfunction ·HOLGER ULLRICH·Product code FQO·July 11, 2018

    ALPHASTAR MOBILE OPERATING TABLE

    FDA Adverse Event
    Malfunction ·HOLGER ULLRICH·Product code FQO·September 26, 2018

    TABLE, OPERATING ROOM, AC POWERED

    FDA Adverse Event
    Malfunction ·HOLGER ULLRICH·Product code FQO·December 19, 2018

    OneTray Sealed Sterilization Containers Product Usage: A rigid sterilization container used to steam sterilize medical devices

    FDA Recall
    Terminated ·Innovative Sterlization Technologies LLC·Product code KCT·February 3, 2014

    Clarity Urocheck 10SG Urinalysis Strips, Model # DTG-10SG Product Usage: Clarity 10SG Urinalysis Reagent Strips (Urine) are for the qualitative and semi-quantitative detection of the following analytes in urine: Glucose, Bilirubin, Ketone (Acetoacetic acid), Specific Gravity, Blood, pH, Protein, Urobilinogen, Nitrite and Leukocytes. The Clarity Urinalysis Reagent Strips (Urine) are for single use in professional near-patient (point-of-care) and centralized laboratory locations, and are intended for professional use only. The strips are intended for use in screening at-risk patients to assist diagnosis in the following areas: kidney function, urinary tract infections, carbohydrate metabolism (e.g. diabetes mellitus), liver function, acid-base balance and urine concentration. The results can be used along with other diagnostic information to rule out certain disease states and to determine if microscopic analysis is needed. The Clarity 10SG Urinalysis Reagent Strips (Urine) can be read visually , on the Clarity Urocheck 120 Urine Analyzers , and on the Clarity Urocheck 120C Urine Analyzers.

    FDA Enforcement
    Class III ·Terminated·Clarity Diagnostics Llc·August 22, 2018

    Clarity Urocheck 10SG Urinalysis Strips, Model # DTG-10SG Product Usage: Clarity 10SG Urinalysis Reagent Strips (Urine) are for the qualitative and semi-quantitative detection of the following analytes in urine: Glucose, Bilirubin, Ketone (Acetoacetic acid), Specific Gravity, Blood, pH, Protein, Urobilinogen, Nitrite and Leukocytes. The Clarity Urinalysis Reagent Strips (Urine) are for single use in professional near-patient (point-of-care) and centralized laboratory locations, and are intended for professional use only. The strips are intended for use in screening at-risk patients to assist diagnosis in the following areas: kidney function, urinary tract infections, carbohydrate metabolism (e.g. diabetes mellitus), liver function, acid-base balance and urine concentration. The results can be used along with other diagnostic information to rule out certain disease states and to determine if microscopic analysis is needed. The Clarity 10SG Urinalysis Reagent Strips (Urine) can be read visually , on the Clarity Urocheck 120 Urine Analyzers , and on the Clarity Urocheck 120C Urine Analyzers.

    FDA Recall
    Terminated ·Clarity Diagnostics Llc·Product code CDM·June 22, 2018

    Healgen Series Reagent strips for Urinalysis are composed of several color pads aligned on a test strip. Each pad is employed for testing one assay item by visually or instrumentally reading the color change of the pad and comparing with the corresponding blocks on a color chart. The Healgen Series Reagent Strips for Urinalysis provides tests for Glucose, Bilirubin, Ketone, Specific Gravity, Blood, pH, Protein, Urobilinogen, Nitrite, Ascorbic Acid and Leukocytes in Urine.

    FDA Recall
    Open, Classified ·Healgen Scientific Llc·Product code JIR·August 22, 2024

    European Healthcare & Device Solutions Ltd.

    Authorized representative
    🇮🇪 Ireland·66 Manufacturers·867 Devices