56 results
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15ms
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Sources: EU EUDAMED, US FDA
GE Healthcare Proteus XR/a, stationary X-Ray System, Model/Catalog Numbers: 1) 2259973; 2) 2259988; 3) 2266999; 4) 2373519; 5) 2379827; 6) 5729352; 7) 2259973-1; 8) 2259973-2; 9) 2259973-3; 10) 2259973-4; 11) Not Available
FDA Enforcement
Class II
·Ongoing·GE Healthcare (China) Co., Ltd.·September 4, 2024
uMI 550 System - Product Usage: 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
·Ongoing·Shanghai United Imaging Healthcare Co., Ltd.·October 6, 2021
uEXPLORER PET/CT System - Product Usage: 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
·Ongoing·Shanghai United Imaging Healthcare Co., Ltd.·October 6, 2021
uEXPLORER 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
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
Digitial Medica X-ray Imagining System, Model: uDR 596i, RX, CE0123, UDI:(01) 06971576833023 - Product Usage: intended to used by a qualified/trained doctor or technician on both adult and pediatric subjects for taking diagnostic radiographic exposures of the skull, spinal column, chest, abdomen, extremities, limbs and trunk. Not for mammography.
FDA Enforcement
Class II
·Terminated·Shanghai United Imaging Healthcare Co., Ltd.·March 10, 2021
Positron Emission Tomography and Computed Tomography System, Model uMI 550, Rx, CE, GTIN: 06971576832026 - Product Usage: 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
·Ongoing·Shanghai United Imaging Healthcare Co., Ltd.·November 18, 2020
Positron Emission Tomography and Computed Tomography System, Model: uMI 550, Material Number: 88000057 - 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 26, 2020
Positron Emission Tomograpy and Computed Tomography System, Model: uMI 550, with software version R001.3.0.0.750505, Rx Only, CE 0197, UDI: (01)06971576832026 - 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.·April 22, 2020
Short Percutaneous Antenna with Thermosphere" Technology Standard Percutaneous Antenna with Thermosphere" Technology; The product is packaged in a blister with a tyvek lid, contained in a display box. The numbers of units per carton is 1. Long Percutaneous Antenna with Thermosphere" Technology Product Usage: The Covidien Emprint Ablation System is intended for use in percutaneous,laparoscopic, and intraoperative coagulation (ablation) of soft tissue, including partial or complete ablation of non-resectable liver tumors. The CovidienEmprint Ablation System is not intended for use in cardiac procedures
FDA Enforcement
Class II
·Terminated·Covidien Medical Products (Shanghai) Manufacturing L.L.C.·March 23, 2016
Incisive CT, model 728143 & 728144 running Software Version 5.0.0.
FDA Enforcement
Class II
·Ongoing·Philips Healthcare (Suzhou) Co., Ltd.·January 17, 2024
DxC 500 AU Clinical Chemistry Analyzer, REF: C63519, and C63520 with affected software.
FDA Enforcement
Class II
·Ongoing·BECKMAN COULTER LABORATORY SYSTEMS (SUZHOU) CO., LTD.·March 5, 2025
DVOT SARS-CoV-2 ANTIGEN TEST KIT, Model Number FCY-AGT-01
FDA Enforcement
Class II
·Ongoing·FENG CHUN YUAN MEDICAL EQUIPMENT (SHENZHEN)CO.,LTD·October 9, 2024
DVOT SARS-Cov-2 &Influenza A+B Antigen Combo Test Kit, Model Number FAT01
FDA Enforcement
Class II
·Ongoing·FENG CHUN YUAN MEDICAL EQUIPMENT (SHENZHEN)CO.,LTD·October 9, 2024
DVOT SARS-CoV-2 & RSV &MP &ADV & FIu A/B Antigen Combo Test Kit, Model Number ACT01
FDA Enforcement
Class II
·Ongoing·FENG CHUN YUAN MEDICAL EQUIPMENT (SHENZHEN)CO.,LTD·October 9, 2024
Beijing Syntech Laser UL Station surgical lasers
FDA Enforcement
Class II
·Ongoing·Beijing Syntech Laser Co., Ltd·May 9, 2018
Beijing Syntech Laser Diode Laser surgical lasers
FDA Enforcement
Class II
·Ongoing·Beijing Syntech Laser Co., Ltd·May 9, 2018
Beijing Syntech Laser UL C02 Laser surgical lasers
FDA Enforcement
Class II
·Ongoing·Beijing Syntech Laser Co., Ltd·May 9, 2018
Beijing Syntech Laser Trixel C02 Laser surgical lasers
FDA Enforcement
Class II
·Ongoing·Beijing Syntech Laser Co., Ltd·May 9, 2018
Beijing Syntech Laser APOLLO JV+ Medical Platform surgical lasers
FDA Enforcement
Class II
·Ongoing·Beijing Syntech Laser Co., Ltd·May 9, 2018