10,000 results
·
58ms
·
Sources: EU EUDAMED, US FDA
Filters
Country: China
×
Laser Fiber (PT-OF-A-S); Laser Fiber (PT-OF-B-S); Laser Fiber (PT-OF-C-S); Laser Fiber (PT-OF-D-S); Laser Fiber (PT-OF-E-S); Laser Fiber (PT-OF-F-S)
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
Multiple Rapid Real-Time PCR kit for Detection of A E gene and Omicron mutation of SARS-CoV-2
Basic UDI-DI
EU IVDD
·
Eu Ivd General
·BEIJING KEWEI CLINICAL DIAGNOSTIC REAGENT INC·1 device
uCT 530 Computed Tomography X-Ray System
FDA Enforcement
Class II
·Ongoing·Shanghai United Imaging Healthcare Co., Ltd.·July 8, 2020
Positron Emission Tomography and Computed Tomography System, Model: uMI 550
FDA Enforcement
Class II
·Ongoing·Shanghai United Imaging Healthcare Co., Ltd.·October 19, 2022
uMI 550 PET/CT Diagnostic Imaging System - Product Usage: This system is intended to be operated by qualified healthcare professionals to assist in the detection, localization, diagnosis, staging, restaging, treatment planning and treatment response evaluation for diseases and disorders in, but not limit to, oncology, cardiology and neurology.
FDA Enforcement
Class II
·Terminated·Shanghai United Imaging Healthcare Co., Ltd.·August 19, 2020
Computed Tomography X-ray System, Model: uCT 550, GTIN: 06971576831036 Intended use The uCT Computed Tomography X-ray System uCT 530/uCT 550 is a computed tomography X-ray system intended to produce cross-sectional images of the body by computer reconstruction of X-ray transmission data taken at different angles and planes and indicated for the whole body (including head, neck and vascular).
FDA Enforcement
Class II
·Ongoing·Shanghai United Imaging Healthcare Co., Ltd.·July 29, 2020
GE Healthcare Revolution ACE, Model number 6670000-3; X-ray/computed tomography systems
FDA Enforcement
Class II
·Ongoing·GE Healthcare (China) Co., Ltd.·December 11, 2024
GE Healthcare Revolution Ascend Elite, Model Number 6967000-100; X-ray/computed tomography system
FDA Enforcement
Class II
·Ongoing·GE Healthcare (China) Co., Ltd.·December 11, 2024
GE Healthcare Operator Console Upgrade Types, FRU Spare Parts Number B80522DA: China Only: Revolution Discovery CT
FDA Enforcement
Class II
·Ongoing·GE Healthcare (China) Co., Ltd.·December 11, 2024
GE Healthcare Revolution Eagle, Model Number 5849504-3, X-ray/computed tomography system
FDA Enforcement
Class II
·Ongoing·GE Healthcare (China) Co., Ltd.·December 11, 2024
GE Healthcare Revolution EVO, Model Number 5454001-260; X-ray/computed tomography system
FDA Enforcement
Class II
·Ongoing·GE Healthcare (China) Co., Ltd.·December 11, 2024
GE Healthcare Revolution Maxima M, Model Number, 6670000-2; X-ray/computed tomography system
FDA Enforcement
Class II
·Ongoing·GE Healthcare (China) Co., Ltd.·December 11, 2024
GE Healthcare Operator Console Upgrade Types, FRU Spare Parts Number B80662DA: China Only: Discovery CT750HD
FDA Enforcement
Class II
·Ongoing·GE Healthcare (China) Co., Ltd.·December 11, 2024
GE Healthcare Optima 520, Catalog number 5439126; X-ray/computed tomography systems
FDA Enforcement
Class II
·Ongoing·GE Healthcare (China) Co., Ltd.·December 11, 2024
GE Healthcare Discovery RT, Model Number 2374681-17, X-ray/computed tomography systems labeled as:
FDA Enforcement
Class II
·Ongoing·GE Healthcare (China) Co., Ltd.·December 11, 2024
GE Healthcare Revolution Maxima Select, Model Number, 6670000-55; X-ray/computed tomography system
FDA Enforcement
Class II
·Ongoing·GE Healthcare (China) Co., Ltd.·December 11, 2024
GE Healthcare Operator Console Upgrade Types, FRU Spare Parts Number B79632DA: EU: RT Refresh Package, Non-EU: Discovery RT, Optima CT580, or Discovery CT590 RT; X-ray/computed tomography system
FDA Enforcement
Class II
·Ongoing·GE Healthcare (China) Co., Ltd.·December 11, 2024
GE Healthcare Revolution Advance, Model number 5849504; X-ray/computed tomography systems
FDA Enforcement
Class II
·Ongoing·GE Healthcare (China) Co., Ltd.·December 11, 2024
GE Healthcare Optima 680 Expert, Model number 6670000; X-ray/computed tomography system
FDA Enforcement
Class II
·Ongoing·GE Healthcare (China) Co., Ltd.·December 11, 2024
GE Healthcare Revolution Ascend, Model number 6969000-100; X-ray/computed tomography system
FDA Enforcement
Class II
·Ongoing·GE Healthcare (China) Co., Ltd.·December 11, 2024