10,000 results
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28ms
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Sources: EU EUDAMED, US FDA
Filters
Country: China
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IDS
Device
EU MDR
·
Eu Md Class 2a
·Guangzhou Berrcom Medical Device Co., Ltd.·On the market·1 country
RITHM ID ELECTROPHYSIOLOGY CATHETER
FDA 510(k)
FDA Class 2
·Cardiovascular
Microbial ID & AST Analyzer
Device
EU IVDR
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Eu Ivd Class A
·Zhuhai Lituo Biotechnology Co., Ltd.·Not intended for eu market
Automated ID/AST Testing System
Device
EU IVDR
·
Eu Ivd Class A
·Shenzhen Mindray Bio-Medical Electronics Co., Ltd.·On the market·2 countries
Automated ID/AST Testing System
Device
EU IVDR
·
Eu Ivd Class A
·Shenzhen Mindray Bio-Medical Electronics Co., Ltd.·On the market·2 countries
Automated ID/AST Testing System
Device
EU IVDR
·
Eu Ivd Class A
·Shenzhen Mindray Bio-Medical Electronics Co., Ltd.·On the market·2 countries
Automated ID/AST Testing System
Device
EU IVDR
·
Eu Ivd Class A
·Shenzhen Mindray Bio-Medical Electronics Co., Ltd.·On the market·2 countries
MYCOPLASMA / UREAPLASMA - (INCL. COMBINED ID-AST)
Device
EU IVDD
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Eu Ivd General
·Sansure Biotech Inc.·On the market
Baby ID Band
Basic UDI-DI
EU MDR
·
Eu Md Class 1
·CHANGZHOU RECOO HEALTHCARE CO., LTD.·1 device
Patient ID Bracelet
Basic UDI-DI
EU MDR
·
Eu Md Class 1
·YIWU EASON MEDICAL DEVICES CO.,LTD.·1 device
Automated ID/AST Testing System
Basic UDI-DI
EU IVDR
·
Eu Ivd Class A
·Shenzhen Mindray Bio-Medical Electronics Co., Ltd.·4 devices
The System is designed as a modular system with components that include an Overhead Tube Suspension with tube/collimator, wallstand, Table, X-ray generator, and cleared wireless digital detectors. The list of detectors verified and validated for use with the Discovery XR656 HD system, including their specifications, are provided in the user documentation. The System generates diagnostic The components may be combined in different configurations to meet specific customer needs. In addition, upgrade configurations are available for predicate devices. The optional image pasting function enables the operator to stitch sequentially acquired radiographs into a single image. This 510(k) is to incorporate the VolumeRad advanced application that was currently available on the Discovery XR656 product onto the Discovery XR656 HD, as well as introduce a new Metal Artifact Reduction Algorithm, and an optional standalone console to take any HelixTM acquired images via DICOM (such as from a Discovery XR656 HD, Optima XR646 HD, or Optima XR240amx) and process the images independently of the system it was acquired on.
FDA Enforcement
Class II
·Ongoing·GE Hangwei Medical Systems, Co. LTD·December 20, 2023
The System is designed as a modular system with components that include an Overhead Tube Suspension with tube/collimator, wallstand, Table, X-ray generator, and cleared wireless digital detectors. The list of detectors verified and validated for use with the Discovery XR656 HD system, including their specifications, are provided in the user documentation. The System generates diagnostic The components may be combined in different configurations to meet specific customer needs. In addition, upgrade configurations are available for predicate devices. The optional image pasting function enables the operator to stitch sequentially acquired radiographs into a single image. This 510(k) is to incorporate the VolumeRad advanced application that was currently available on the Discovery XR656 product onto the Discovery XR656 HD, as well as introduce a new Metal Artifact Reduction Algorithm, and an optional standalone console to take any HelixTM acquired images via DICOM (such as from a Discovery XR656 HD, Optima XR646 HD, or Optima XR240amx) and process the images independently of the system it was acquired on.
FDA Enforcement
Class II
·Ongoing·GE Hangwei Medical Systems, Co. LTD·December 20, 2023
SIGNA Creator, SIGNA Explorer, NMRI systems
FDA Enforcement
Class II
·Ongoing·GE Healthcare (China) Co., Ltd.·March 5, 2025
Brivo MR355, NMRI system
FDA Enforcement
Class II
·Ongoing·GE Healthcare (China) Co., Ltd.·March 5, 2025
Optima MR360, NMRI system
FDA Enforcement
Class II
·Ongoing·GE Healthcare (China) Co., Ltd.·March 5, 2025
SIGNA MR355, SIGNA MR360, NMRI system
FDA Enforcement
Class II
·Ongoing·GE Healthcare (China) Co., Ltd.·March 5, 2025
SIGNA MR380, NMRI system, Non-US Only
FDA Enforcement
Class II
·Ongoing·GE Healthcare (China) Co., Ltd.·March 5, 2025
CYP2D6*10\CYP2C9*3\ADRB1(1165G>C)\AGTR1(1166A>C)\ACE(I/D) Detection Kit (PCR-Melting Curve Method)
Basic UDI-DI
EU IVDD
·
Eu Ivd General
·Wuxi Ruiqi Gene Biotechnology Co., Ltd.·1 device
CYP2D6*10\CYP2C9*3\ADRB1(1165G>C)\AGTR1(1166A>C)\ACE(I/D) Detection Kit (PCR-Melting Curve Method)
Basic UDI-DI
EU IVDD
·
Eu Ivd General
·Wuxi Ruiqi Gene Biotechnology Co., Ltd.·1 device