616 results
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14ms
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Sources: EU EUDAMED, US FDA
Filters
Status: Ongoing
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Streptococcal A rapid test kits, labeled as: Wondfo Biotech Co., Ltd, WondView Strep A Test Kit, Guangzhou Wondfo Biotech Co., Ltd, Wondfo One Step Strep A Swab Test, Dealmed Medical Supplies LLC, Strep A Rapid Test Kit, Jant Pharmacal Corporation, Accustrip VALUPAK Strep A Test Strip, SMC Direct, LLC, RefuAH Strep A Rapid,
FDA Enforcement
Class II
·Ongoing·Wondfo USA Co Ltd·June 19, 2024
Shanghai United Imaging Healthcare Co., Ltd. Computed Tomography X-ray System, Model:uCT ATLAS MD, Rx Only
FDA Enforcement
Class II
·Ongoing·UIH Technologies LLC·October 29, 2025
Shanghai United Imaging Healthcare Co., Ltd. Computed Tomography X-ray System, Model:uCT 780 MD, Rx Only
FDA Enforcement
Class II
·Ongoing·UIH Technologies LLC·October 29, 2025
Shanghai United Imaging Healthcare Co., Ltd. Positron Emission Tomography and Computed Tomography System Model:uEXPLORER MD, Rx Only
FDA Enforcement
Class II
·Ongoing·UIH Technologies LLC·October 29, 2025
Shanghai United Imaging Healthcare Co., Ltd. Positron Emission Tomography and Computed Tomography System Model:uMI 780 MD, Rx Only
FDA Enforcement
Class II
·Ongoing·UIH Technologies LLC·October 29, 2025
Shanghai United Imaging Healthcare Co., Ltd. Positron Emission Tomography and Computed Tomography System Model:uMI Panorama 35 MD, Rx Only
FDA Enforcement
Class II
·Ongoing·UIH Technologies LLC·October 29, 2025
OXOID MICROBACT IDENTIFICATION KITS, Listeria 12L Kit, 20 Tests; Listeria identification sysystem
FDA Enforcement
Class II
·Ongoing·Oxoid Australia Pty Limited·April 8, 2026
Shanghai United Imaging Healthcare Co., Ltd. Computed Tomography X-ray System, Model:uCT 530 MD, Rx Only
FDA Enforcement
Class II
·Ongoing·UIH Technologies LLC·October 29, 2025
Shanghai United Imaging Healthcare Co., Ltd. Computed Tomography X-ray System, Model:uCT 760 MD, Rx Only
FDA Enforcement
Class II
·Ongoing·UIH Technologies LLC·October 29, 2025
NANOSONICS LTD Sonex-HL Ultrasound Probe Disinfectant trophon Sonex-HL 80 mL Bottle For Trophon EPR Disinfection System Model Number: N00037
FDA Enforcement
Class II
·Ongoing·Mckesson Medical-Surgical Inc. Corporate Office·August 31, 2022
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
GaGa Pro Lighting Equipment Co. Ltd. manufactures Class IV Laser Light Show (LLS)projectors for the purposes of demonstration and entertainment.
FDA Enforcement
Class II
·Ongoing·GAGA PRO LIGHTING EQUIPMENT CO.,·April 5, 2023
Shanghai United Imaging Healthcare Co., Ltd. Computed Tomography X-ray System, Model:uCT 550 MD, Rx Only
FDA Enforcement
Class II
·Ongoing·UIH Technologies LLC·October 29, 2025
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
Shanghai United Imaging Healthcare Co., Ltd. Positron Emission Tomography and Computed Tomography System Model:uMI 550 MD, Rx Only
FDA Enforcement
Class II
·Ongoing·UIH Technologies LLC·October 29, 2025
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
Osstem Dental X-Ray System T1. Product Model Numbers T1-C and T1-CS.
FDA Enforcement
Class II
·Ongoing·OSSTEM Implant Co., Ltd.·November 12, 2025