7 results
·
14ms
·
Sources: EU EUDAMED, US FDA
Filters
Country: China
×
Disposable Laryngoscope Blade
Basic UDI-DI
EU MDD
·
Eu Md Class 1
·Hangzhou Tappa Medical Technology Co , Ltd.·1 device
QC Solution
Basic UDI-DI
EU IVDD
·
Eu Ivd General
·Genrui Biotech Inc.·1 device
Quality Control Solution (QC Solution)
Basic UDI-DI
EU IVDD
·
Eu Ivd General
·Genrui Biotech Inc.·1 device
GE Brivo OEC715/785/865 C-Arm, Models: 715 Prime, 785 Essential, and 865 Plus. The QEC Brivo Mobile C-Arm X-Ray Products are designed to provide digital spot film imaging and fluoroscopic image guidance for all adult and pediatric populations for orientations between patient anatomy and surgical instruments. The product is used for general surgical applications and musculoskeletal procedures to visualize, for example, implant localizations or needle positions for aspirations,injections or biopsy.
FDA Enforcement
Class II
·Terminated·GE Healthcare Beijing , Hangwei Medical Systems, Co. LTD·October 30, 2013
Assayed Multiple Chemistry Control (Multi-QC)
Basic UDI-DI
EU IVDD
·
Eu Ivd General
·Maccura Biotechnology Co., Ltd. ·1 device
Assayed Multiple Chemistry Control (Multi-QC)
Basic UDI-DI
EU IVDD
·
Eu Ivd General
·Maccura Biotechnology Co., Ltd. ·1 device
Assayed Multiple Chemistry Control (Multi-QC)
Basic UDI-DI
EU IVDD
·
Eu Ivd General
·Maccura Biotechnology Co., Ltd. ·2 devices