BEUDAMED
    68 results · 6ms · Sources: EU EUDAMED, US FDA

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    Filters Classification: Class I × Status: Ongoing × Clear all

    Jiangsu Well Biotech Co.,Ltd. AND SDI LABS COVID-19 Ag Rapid Test Device - Cat#: CO-02

    FDA Enforcement
    Class I ·Ongoing·Jiangsu Well Biotech Co.,Ltd.·October 19, 2022

    Handy Solutions Neck & Shoulders Heating Pad, Number: 25607, Manufactured by Ninbo Unico Products Co., Ltd

    FDA Enforcement
    Class I ·Ongoing·Navajo Manufacturing Company·April 1, 2026

    BD¿Spinal Tray with BD¿Whitacre Needle 22 G x 3.5 in.; lidocaine HCL (1%), 5 mL, bupivacaine HCL (0.75%) with dextrose (8.25%), 2 mL (marcaine). Catalog Number: 405645.

    FDA Enforcement
    Class I ·Ongoing·Becton Dickinson & Company·June 10, 2026

    BD¿Spinal Tray with BD¿Quincke Needle 26 G x 3.5 in.; lidocaine HCL (1%), 5 mL, bupivacaine HCL (0.75%) with dextrose (8.25%), 2 mL (marcaine). Catalog Number: 405632.

    FDA Enforcement
    Class I ·Ongoing·Becton Dickinson & Company·June 10, 2026

    BD¿Spinal Tray with BD¿Whitacre Needle 25 G x 3.5 in.; lidocaine HCL (1%), 5 mL, bupivacaine HCL (0.75%) with dextrose (8.25%), 2 mL (marcaine). Catalog Number: 405671.

    FDA Enforcement
    Class I ·Ongoing·Becton Dickinson & Company·June 10, 2026

    BD¿Spinal Tray with BD¿Whitacre Needle 25 G x 3.5 in.; lidocaine HCL (1%), 2 mL, bupivacaine HCL (0.75%) with dextrose (8.25%), 2 mL (marcaine). Catalog Number: 405658.

    FDA Enforcement
    Class I ·Ongoing·Becton Dickinson & Company·June 10, 2026

    BD¿Spinal Tray with BD¿Quincke Needle 22 G x 3.5 in.; lidocaine HCL (1%), 5 mL, bupivacaine HCL (0.75%) with dextrose (8.25%), 2 mL (marcaine). Catalog Number: 405609.

    FDA Enforcement
    Class I ·Ongoing·Becton Dickinson & Company·June 10, 2026

    BD¿Spinal Tray with BD¿Whitacre Needle 25 G x 3.5 in., BD¿Quincke Needle 22 G x 3.5 in.; lidocaine HCL (1%), 5 mL, bupivacaine HCL (0.75%) with dextrose (8.25%), 2 mL (marcaine). Catalog Number: 405741.

    FDA Enforcement
    Class I ·Ongoing·Becton Dickinson & Company·June 10, 2026

    BD¿Spinal Tray with BD¿Quincke Needle 25 G x 3.5 in.; lidocaine HCL (1%), 5 mL, bupivacaine HCL (0.75%) with dextrose (8.25%), 2 mL (marcaine). Catalog Numbers: 405621, 405735.

    FDA Enforcement
    Class I ·Ongoing·Becton Dickinson & Company·June 10, 2026

    Spinocan Spinal Needle procedure kits: Material Description (Material Number): Spinocan 26 Ga. x 3-1/2 in. (90 mm), Bupivacaine 0.75% with Dextrose 8.25% Tray (Kit) (333201); Spinocan 25 Ga. x 3-1/2 in. (90 mm), Bupivacaine 0.75% with Dextrose 8.25% Tray (Kit) (333211); Spinocan 22 Ga. x 3-1/2 in. (90 mm), Bupivacaine 0.75% with Dextrose 8.25% Tray (Kit) (333231)

    FDA Enforcement
    Class I ·Ongoing·B Braun Medical Inc·June 10, 2026

    BD¿Spinal Tray with BD¿Whitacre Needle 25 G x 3.5 in.; lidocaine HCL (1%), 5 mL, bupivacaine HCL (0.75%) with dextrose (8.25%), 2 mL (marcaine). Catalog Numbers: 405637, 405707.

    FDA Enforcement
    Class I ·Ongoing·Becton Dickinson & Company·June 10, 2026

    BD¿Spinal Tray with BD¿Whitacre Needle 24 G x 3.5 in.; lidocaine HCL (1%), 5 mL, bupivacaine HCL (0.75%) with dextrose (8.25%), 2 mL (marcaine). Catalog Numbers: 400868, 405652.

    FDA Enforcement
    Class I ·Ongoing·Becton Dickinson & Company·June 10, 2026

    BD¿Spinal Tray with BD¿Whitacre Needle 25 G x 3.5 in.; lidocaine HCL (1%), 5 mL, bupivacaine HCL (0.75%) with dextrose (8.25%), 2 mL (marcaine). Catalog Numbers: 400866, 405672, 405673, 405674, 405675, 405709, 405721, 405723, 406704.

    FDA Enforcement
    Class I ·Ongoing·Becton Dickinson & Company·June 10, 2026

    Spinal Needle procedure kits: Material Description (Material Number) 24GA. PENCAN SPINAL BUP. TRAY W/DURAPREP (333867); 25GA. PENCAN SPINAL BUP. TRAY W/DURAPREP (333862); GOVP24BK 24G PENCAN TRAY W/ BUP & DEXTROS (332607); P24BK 24G PENCAN TRAY W/BUP & DEXTROSE (333868); P25BKAY PENCAN SPINAL TRAY (333865); P27BK PENCAN SPINAL W/BUPIVAC (333871); P25BK SPINAL TRAY (333851)

    FDA Enforcement
    Class I ·Ongoing·B Braun Medical Inc·June 10, 2026

    NOxBOXi Nitric Oxide Delivery System; Model Numbers: NOXBOX-I

    FDA Enforcement
    Class I ·Ongoing·NOXBOX LTD·October 15, 2025

    NOxBOXi Nitric Oxide Delivery System; Model Numbers: NOXBOX-I

    FDA Enforcement
    Class I ·Ongoing·NOXBOX LTD·October 15, 2025

    Ellume COVID-19 Home Test

    FDA Enforcement
    Class I ·Ongoing·ELLUME LTD·November 17, 2021

    AirFit N10 Nasal Masks and User Guide

    FDA Enforcement
    Class I ·Ongoing·ResMed Ltd.·December 27, 2023

    AirFit N20 Nasal Mask and User Guide

    FDA Enforcement
    Class I ·Ongoing·ResMed Ltd.·December 27, 2023

    AirTouch N20 Nasal Mask and User Guide

    FDA Enforcement
    Class I ·Ongoing·ResMed Ltd.·December 27, 2023