BEUDAMED
    7 results · 13ms · Sources: EU EUDAMED, US FDA

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    nanoDot B - item 2 of 3 for 03500-000, Model Number 03502-000; radiation monitoring dosimeter used with the microSTAR readers

    FDA Enforcement
    Class II ·Completed·Landauer·September 20, 2023

    nanoDot A - item 1 of 3 for 03500-000, Model Number 03501-000; radiation monitoring dosimeter used with the microSTAR readers

    FDA Enforcement
    Class II ·Completed·Landauer·September 20, 2023

    nanoDot C - item 3 of 3 for 03500-000, Model Number 03503-000; radiation monitoring dosimeter used with the microSTAR readers

    FDA Enforcement
    Class II ·Completed·Landauer·September 20, 2023

    nanoDot A - item 1 of 3 for 03500-000, Model Number 03501-000; radiation monitoring dosimeter used with the microSTAR readers

    FDA Recall
    Completed ·Product code IYE·July 12, 2023

    nanoDot B - item 2 of 3 for 03500-000, Model Number 03502-000; radiation monitoring dosimeter used with the microSTAR readers

    FDA Recall
    Completed ·Product code IYE·July 12, 2023

    Humeral Augmented Tray (HAT) trials that are components of KIT-321HAT. Each tray contains 1 of each of the following catalog numbers for a total of 6 trials/tray: (1) HAT STD Left Tray Trial, Cat. #321-00-01; (2) HAT STD Right Tray Trial, Cat. #321-00-02; (3) HAT LAT Left Tray Trial, Cat. #321-00-11; (4) HAT LAT Right Tray Trial, Cat. #321-00-12; (5) HAT EXT LAT Left Trial, Cat. #321-00-21; and (6) HAT EXT LAT Right Trial, Cat. #321-00-22. The Humeral Augmented Tray is designed to function with the Equinoxe Reverse Shoulder System orthopedic implant components.

    FDA Enforcement
    Class II ·Completed·Exactech, Inc.·July 7, 2021

    Humeral Augmented Tray (HAT) trials that are components of KIT-321HAT. Each tray contains 1 of each of the following catalog numbers for a total of 6 trials/tray: (1) HAT STD Left Tray Trial, Cat. #321-00-01; (2) HAT STD Right Tray Trial, Cat. #321-00-02; (3) HAT LAT Left Tray Trial, Cat. #321-00-11; (4) HAT LAT Right Tray Trial, Cat. #321-00-12; (5) HAT EXT LAT Left Trial, Cat. #321-00-21; and (6) HAT EXT LAT Right Trial, Cat. #321-00-22. The Humeral Augmented Tray is designed to function with the Equinoxe Reverse Shoulder System orthopedic implant components.

    FDA Recall
    Completed ·Exactech, Inc.·Product code PHX·May 11, 2021