BEUDAMED
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    SYVA® EMIT

    FDA Adverse Event
    Malfunction ·SIEMENS HEALTHCARE DIAGNOSTICS INC.·Product code KLR·January 7, 2020

    SYVA® EMIT

    FDA Adverse Event
    Malfunction ·SIEMENS HEALTHCARE DIAGNOSTICS INC.·Product code KLR·January 7, 2020

    Enzyme Immunoassay, Lidocaine

    FDA classification
    FDA Class 2 ·Enzyme Immunoassay, Lidocaine

    GAMBRO POLYFLUX 6 LR, 8 LR AND 10 LR

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology

    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

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

    CLR MEDICAL, INC.

    FDA registration
    CLR MEDICAL, INC.·2 products·🇺🇸 United States

    SENSATION CATHETER

    FDA Adverse Event
    Injury ·GETINGE·Product code DSP·May 7, 2024

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

    KLC SERVICES, INC./REEP

    FDA registration
    KLC SERVICES, INC./REEP·1 product·🇺🇸 United States

    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

    KAR BOW INDUSTRIES CO., LTD.

    FDA registration
    KAR BOW INDUSTRIES CO., LTD.·1 product·🇨🇳 China

    POLYFLUX FAMILY HEMODIALYZER/FILTER LABELED FOR SINGLE AND MULTIPLE USE, MODELS 14L, 17L, 21L, 140H, 170H, 210H,6LR, 8LR

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology

    I-Series Washers

    FDA UDI
    SKYTRON LLC·10841736100360·I5 Universal two level processing rack, with 1 ...

    I-Series Washers

    FDA UDI
    SKYTRON LLC·10841736100377·I5 Three level processing rack, with 2 rotating...

    ROC Crown 3LR

    FDA UDI
    SPECIALTY APPLIANCES, LLC·D8199001470·

    SS Crown 2LR

    FDA UDI
    SPECIALTY APPLIANCES, LLC·D8199001070·

    SS Crown 3LR

    FDA UDI
    SPECIALTY APPLIANCES, LLC·D8199001080·

    I-Series Washers

    FDA UDI
    SKYTRON LLC·10841736100384·I5 Four level processing rack, with 3 rotating ...

    MEDICAL DISPLAY, MDC1900-1LG (1LR)

    FDA 510(k)
    FDA Class 2 ·Radiology