BEUDAMED
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    Products are labeled as: Skippack Medical Lab SARS-CoV-2 Antigen Rapid Test Kit (Colloidal Gold) 20 TESTS/1 KIT Green and white box under the brand DiagnosUS, and, White box without brand name labeled as "SARS -COV-2 ANTIGEN DEVELOPMENT MADE IN USA ORAL SWAB TESTING

    FDA Enforcement
    Class I ·Ongoing·Universal Meditech Inc.·February 8, 2023

    Skippack Medical Lab SARS-CoV-2 Antigen Rapid Test Kit (Colloidal Gold); COVID 19 Test

    FDA Enforcement
    Class I ·Ongoing·SML Distribution, LLC·May 11, 2022

    VALIANT STENT GRAFT

    FDA Adverse Event
    Injury ·MEDTRONIC IRELAND·Product code MIH·July 14, 2020

    VALIANT STENT GRAFT

    FDA Adverse Event
    Malfunction ·MEDTRONIC IRELAND·Product code MIH·July 14, 2020

    ANCURE ENDOGRAFT (FORMERLY EVT ENDOGRAFT)

    FDA Adverse Event
    Injury ·GUIDANT ENDOVASCULAR SOLUTIONS·Product code MIH·May 19, 2016

    VENTANA FOLR1RXDX TEST

    FDA Adverse Event
    Injury ·VENTANA MEDICAL SYSTEMS, INC.·Product code QUL·February 2, 2024

    VALIANT STENT GRAFT

    FDA Adverse Event
    Injury ·MEDTRONIC IRELAND·Product code MIH·July 3, 2025

    VALIANT STENT GRAFT

    FDA Adverse Event
    Malfunction ·MEDTRONIC IRELAND·Product code MIH·July 3, 2025

    VALIANT CAPTIVIA UNK

    FDA Adverse Event
    Injury ·MEDTRONIC IRELAND·Product code MIH·May 15, 2024

    Immunohistochemistry Assay, Antibody, Folr1

    FDA classification
    FDA Class 3 ·Immunohistochemistry Assay, Antibody, Folr1

    IUL SA

    FDA registration
    IUL SA·2 products·🇪🇸 Spain

    iPeak® reader 4,3" Lateral Flow Reader

    FDA UDI
    IUL SA·08437022431482·The iPeak® reader 4,3” Lateral Flow Reader (SW ...

    PUL Technologies LLC.

    FDA registration
    PUL Technologies LLC.·2 products·🇺🇸 United States

    QEL DOMINICANA S.A.

    FDA registration
    QEL DOMINICANA S.A.·3 products·🇩🇴 Dominican Republic

    TS ROC Crown Component 4UR (5/pk), TS ROC Crown Component 5UR (5/pk), TS ROC Crown Component 6UR (5/pk), TS ROC Crown Component 7UR (5/pk), TS ROC Crown Component 8UR (5/pk), TS ROC Crown Component 4LR (5/pk), TS ROC Crown Component 5LR (5/pk), TS ROC Crown Component 6LR (5/pk), TS ROC Crown Component 7LR (5/pk), TS ROC Crown Component 8LR (5/pk), TS ROC Crown Component 4UL (5/pk), TS ROC Crown Component 5UL (5/pk), TS ROC Crown Component 6UL (5/pk), TS ROC Crown Component 7UL (5/pk), TS ROC Crown Component 8UL (5/pk), TS ROC Crown Component 4LL (5/pk), TS ROC Crown Component 5LL (5/pk), TS ROC Crown Component 6LL (5/pk), TS ROC Crown Component 7LL (5/pk), TS ROC Crown Component 8LL (5/pk) A Herbst Appliance is used to affect changes in the skeletal relationship and/or occlusion of a patient. the Universal Nut is a component of a Herbst Appliance.

    FDA Recall
    Terminated ·Specialty Appliance Works, Inc.·Product code ECN·March 9, 2015

    SS Crown 2UL

    FDA UDI
    SPECIALTY APPLIANCES, LLC·D8199001140·

    ROC Crown 3UL

    FDA UDI
    SPECIALTY APPLIANCES, LLC·D8199001410·

    SS Crown 3UL

    FDA UDI
    SPECIALTY APPLIANCES, LLC·D8199001150·

    TS Crown Component 4UR (5/pk), TS Crown Component 5UR (5/pk), TS Crown Component 6UR (5/pk), TS Crown Component 4LR (5/pk), TS Crown Component 5LR (5/pk), TS Crown Component 6LR (5/pk), TS Crown Component 4UL (5/pk), TS Crown Component 5UL (5/pk), TS Crown Component 4LL (5/pk), TS Crown Component 5LL (5/pk), and TS Crown Component 6LL (5/pk) A Herbst Appliance is used to affect changes in the skeletal relationship and/or occlusion of a patient. the Universal Nut is a component of a Herbst Appliance

    FDA Enforcement
    Class II ·Terminated·Specialty Appliance Works, Inc.·April 29, 2015

    Inoculating Loop 1ul Typenex

    FDA UDI
    ZHEJIANG RUNLAB TECHNOLOGY CO., LTD·06973267011161·1ul,rigid,dark blue, LP0102