BEUDAMED
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    SMART WATCH HEALTHY SPORT HEART RATE

    FDA Adverse Event
    Malfunction ·UNKNOWN·Product code QDA·October 31, 2024

    AMS BUN UREA NITROGEN For the In vitro quantitative determination of Urea Nitrogen in serum Quantitative determination of Bun in serum.

    FDA Recall
    Terminated ·AMS Diagnostics, LLC·Product code NJT·February 11, 2014

    AMS AST For the In vitro quantitative determination of AST in serum Quantitative determination of AST in serum.

    FDA Recall
    Terminated ·AMS Diagnostics, LLC·Product code NJT·February 11, 2014

    AMS URIC ACID For the In vitro quantitative determination of Uric Acid in serum Quantitative determination of Uric Acid in serum.

    FDA Recall
    Terminated ·AMS Diagnostics, LLC·Product code NJT·February 11, 2014

    Medica ISE Module Calibrant A; 500 mL - 140 mmol/L Na+, 125 mmol/L Cl-, buffers and preservatives; For use with ISE Module; Product Usage: Calibrations of ISE Model for integrated electrolyte system analysis.

    FDA Recall
    Open, Classified ·AMS Diagnostics, LLC·Product code JIX·February 29, 2016

    Medica ISE Module Calibrant A; 500 mL - 140 mmol/L Na+, 125 mmol/L Cl-, buffers and preservatives; For use with ISE Module; Product Usage: Calibrations of ISE Model for integrated electrolyte system analysis.

    FDA Enforcement
    Class III ·Ongoing·AMS Diagnostics, LLC·July 19, 2017

    AMS BUN UREA NITROGEN For the In vitro quantitative determination of Urea Nitrogen in serum Quantitative determination of Bun in serum.

    FDA Enforcement
    Class II ·Terminated·AMS Diagnostics, LLC·April 2, 2014

    AMS AST For the In vitro quantitative determination of AST in serum Quantitative determination of AST in serum.

    FDA Enforcement
    Class II ·Terminated·AMS Diagnostics, LLC·April 2, 2014

    AMS URIC ACID For the In vitro quantitative determination of Uric Acid in serum Quantitative determination of Uric Acid in serum.

    FDA Enforcement
    Class II ·Terminated·AMS Diagnostics, LLC·April 2, 2014

    MEMORYGEL¿ BREAST IMPLANT ¿ SMOOTH ROUND MODERATE PLUS PROFILE (400CC)

    FDA Adverse Event
    Injury ·MENTOR WORLDWIDE LLC·Product code FTR·December 26, 2025

    MEMORYGEL¿ BREAST IMPLANT ¿ SMOOTH ROUND MODERATE PLUS PROFILE (400CC)

    FDA Adverse Event
    Injury ·MENTOR WORLDWIDE LLC·Product code FTR·December 26, 2025

    COLORECTAL CANCER SCREENING (IFOB) TEST KIT

    FDA Adverse Event
    Injury ·2SAN LLC.·Product code KHE·March 24, 2025

    FaStep COVID-19 IgG/IgM Rapid Test Device Qualitative detection and differentiation of IgM and IgG antibodies to SARS-CoV-2 in human venous whole blood (sodium EDTA), serum, plasma (sodium EDTA) and fingerstick whole blood. Intended for use as an aid in identifying individuals with an adaptive immune response to SARS-CoV-2, indicating recent or prior infection. (CLIA Waived Laboratories)

    FDA Recall
    Terminated ·Versea Diagnostics LLC·Product code QKO·July 27, 2021

    CareStart COVID-19 Antigen Rapid Diagnostic Test for the detection of SARS-CoV-2 Antigen Qualitative detection of the nucleocapsid protein antigen from SARS-CoV-2 in nasopharyngeal or anterior nasal swab specimens directly collected from individuals suspected of COVID-19 by their healthcare provider within five days of symptom onset, or from individuals without symptoms or other epidemiological reasons to suspect COVID-19 when tested twice over two or three days with at least 24 hours and no more than 48 hours between tests. (CLIA Waived Laboratories)

    FDA Recall
    Terminated ·Versea Diagnostics LLC·Product code QKP·July 27, 2021

    Status COVID-19/Flu Rapid Immunoassay for Direct Detection and Differential Diagnosis of SARS-CoV-2, Influenzas Type A, and Type B Antigens Simultaneous qualitative detection and differentiation of nucleocapsid antigen from SARS-CoV-2, influenza A and influenza B directly from nasopharyngeal swab specimens obtained from individuals, who are suspected of respiratory viral infection consistent with COVID-19 by their healthcare provider, within the first five days of onset of symptoms. Emergency use of this test is limited to authorized laboratories. (CLIA Waived Laboratories)

    FDA Recall
    Terminated ·Versea Diagnostics LLC·Product code QMN·July 27, 2021

    Healgen COVID-19 IgG/IgM Rapid Test Cassette (Whole Blood/Serum/Plasma) Qualitative detection and differentiation of IgM and IgG antibodies against SARS-CoV-2 in human venous whole blood, plasma (Li+- heparin, K2-EDTA and sodium-citrate), and serum. Intended for use as an aid in identifying individuals with an adaptive immune response to SARS-CoV-2, indicating recent or prior infection. Emergency use of this test is limited to authorized laboratories. Authorized Laboratories: Laboratories certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA), 42 U.S.C. 263a, to perform moderate or high complexity tests

    FDA Recall
    Terminated ·Versea Diagnostics LLC·Product code QKO·July 27, 2021

    CoaguChek XS PT Test; All Catalog/REF Numbers that do NOT end in 160 The CoaguChek XS PT test strips are part of the CoaguChek XS System. The CoaguChek XS System is intended for properly selected and suitably trained users or their caregivers on the prescription or other order of the treating doctor.

    FDA Recall
    Terminated ·TERRIFIC CARE LLC 61 Willet St Bldg A-1, Fl 2 Passaic NJ 07055-1971·Product code GJS·December 20, 2018

    SEKISUI DIAGNOSTICS LLC SERUM HCG OSOMGENZME CONTROL SET.

    FDA Recall
    Open, Classified ·Mckesson Medical-Surgical Inc. Corporate Office 9954 Maryland Drive Deep Run Iii Ste. 4000 Richmond VA 23233·Product code JJX·April 24, 2025

    MedEnvoy Global BV

    Authorized representative
    🇳🇱 Netherlands·143 Manufacturers·2306 Devices

    Emergo Europe B.V.

    Authorized representative
    🇳🇱 Netherlands·900 Manufacturers·22100 Devices