31 results
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47ms
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Sources: EU EUDAMED, US FDA
SOFTCARE CO., LTD.
FDA registration
SOFTCARE CO., LTD.·2 products·🇯🇵 Japan
Laser Speckle Flowgraphy LSFG-NAVI
FDA UDI
SOFTCARE CO., LTD.·04589662680035·
Laser Speckle Flowgraphy LSFG-NAVI
FDA UDI
SOFTCARE CO., LTD.·04589662680028·
Hangzhou Microimage Software Co.,Ltd
Manufacturer
🇨🇳 China
Guangzhou Shijing Medical Software Co., Ltd.
Manufacturer
🇨🇳 China
Guangzhou Shijing Medical Software Co., Ltd.
Manufacturer
🇨🇳 China·3 Basic UDI-DIs·3 Devices
Nanjing Yuyue Software Technology Co., Ltd.
Manufacturer
🇨🇳 China
NEUROSTIMULATORS PROGRAMMERS - MEDICAL DEVICE SOFTWARE
Device
EU MDR
·
Eu Md Class 1
·Guangzhou Shijing Medical Software Co., Ltd.·On the market
NEUROSTIMULATORS PROGRAMMERS - MEDICAL DEVICE SOFTWARE
Device
EU MDR
·
Eu Md Class 1
·Guangzhou Shijing Medical Software Co., Ltd.·On the market
NEUROSTIMULATORS PROGRAMMERS - MEDICAL DEVICE SOFTWARE
Device
EU MDR
·
Eu Md Class 1
·Guangzhou Shijing Medical Software Co., Ltd.·On the market
TM-300 Traction System; an Rx software driven device used for patient traction; Manufactured for Sammons Preston Roylan, An Ability One Company, Bolingbrook, IL 60440, Manufactured by: ITO Co., Ltd., 3-3-3 Toyotama-Minami, Nerima-ku, Tokyo, 176-8605, Japan
FDA Recall
Terminated
·Sammons Preston Rolyan, An Ability One Company·Product code HST·July 13, 2005
Shanghai United Imaging Healthcare Co., Ltd. Positron Emission Tomography (PET) and Computed Tomography (CT), Model uMI 550 Part Number: 88000657 88000057
FDA Enforcement
Class II
·Ongoing·Shanghai United Imaging Healthcare Co., Ltd.·April 19, 2023
NeuViz 128 Multi-slice CT Scanner System with software version 1.0.7.4038+P06 or previous version
FDA Recall
Terminated
·Neusoft Medical Systems Co., Ltd. NO.·Product code JAK·August 31, 2016
NeuViz 64 Multi-slice CT Scanner Systems
FDA Recall
Terminated
·Neusoft Medical Systems Co., Ltd. NO.·Product code JAK·August 31, 2016
Training Software For Visual Function Therapy
Basic UDI-DI
EU MDR
·
Eu Md Class 1
·Guangzhou Shijing Medical Software Co., Ltd.·1 device
Training Software For Visual Function Therapy
Basic UDI-DI
EU MDR
·
Eu Md Class 1
·Guangzhou Shijing Medical Software Co., Ltd.·1 device
Training Software For Visual Function Therapy
Basic UDI-DI
EU MDR
·
Eu Md Class 1
·Guangzhou Shijing Medical Software Co., Ltd.·1 device
Shanghai United Imaging Healthcare Co., Ltd. Positron Emission Tomography (PET) and Computed Tomography (CT), Model uMI 550 Part Number: 88000657 88000057
FDA Recall
Open, Classified
·Shanghai United Imaging Healthcare Co., Ltd.
No. 2258 Chengbei Rd, Jiading Ind.
Shanghai China·Product code KPS·March 1, 2023
NeuViz Dual series Computed Tomography (CT) Scanner System, X-Ray System. Part Number: 989605651321. Intended to produce cross-section images of head and body by computer reconstruction of X-ray transmission data taken at different angles.
FDA Recall
Terminated
·Neuisys, LLC·Product code JAK·July 21, 2008
Brand Name: MiniDock Product Name: Integrated Nucleic Acid Testing Device Model/Catalog Number: PM001 Software Version: N/A Product Description: 1. Product Overview 1.1 Product Name: Integrated Nucleic Acid Testing Device Brand Name: MiniDock 1.2 Model: PM001 2.Product composition: This device consists of the main unit, power cord, data cable, power adapter, chip bracket, and instruction manual packaging. Component: No
FDA Recall
Open, Classified
·Guangzhou Pluslife Biotech Co., Ltd.·Product code QKP·January 24, 2025