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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
UNIVERSE OPTICAL MFG CO., LTD.
Manufacturer
🇨🇳 China·1 Importer
SHANGHAI PIGEON DENTAL MFG.,CO.LTD.
Manufacturer
🇨🇳 China·1 Importer
ZHENJIANG SELECT OPTICAL MFG CO LTD.
Manufacturer
🇨🇳 China·1 Basic UDI-DI·1 Device
Dongguan QueenMed Equipment Mfg Co Ltd
Manufacturer
🇨🇳 China·33 Basic UDI-DIs·33 Devices·DNV MEDCERT GmbH and DNV MEDCERT GmbH
INSPIRATION MFG. & TRADING CO.
FDA registration
INSPIRATION MFG. & TRADING CO.·8 products·🇨🇳 China
HU-FRIEDY MFG. CO. LLC
FDA registration
HU-FRIEDY MFG. CO. LLC·8 products·🇨🇳 China
TR Optical Mfg Co., Ltd
FDA registration
TR Optical Mfg Co., Ltd·4 products·🇨🇳 China
UNIVERSE OPTICAL MFG CO.,LTD
FDA registration
UNIVERSE OPTICAL MFG CO.,LTD·4 products·🇨🇳 China
MEDIPACK MEDICAL PACKAGING MFG. CO.
FDA registration
MEDIPACK MEDICAL PACKAGING MFG. CO.·5 products·🇨🇳 China
LIVEN SPORTS MFG. (XIAMEN) CO., LTD.
FDA registration
LIVEN SPORTS MFG. (XIAMEN) CO., LTD.·21 products·🇨🇳 China
LEADING HARDWARE (NINGBO) MACHINERY MFG. CO.,LTD.
FDA registration
LEADING HARDWARE (NINGBO) MACHINERY MFG. CO.,LTD.·3 products·🇨🇳 China
DONG GUAN QUEENMED EQUIPMENT MFG CO LTD
FDA registration
DONG GUAN QUEENMED EQUIPMENT MFG CO LTD·2 products·🇨🇳 China
MONOFOCAL ORGANIC OPHTHALMIC LENSES
Device
EU MDR
·
Eu Md Class 1
·ZHENJIANG SELECT OPTICAL MFG CO LTD.·On the market·32 countries
Electrosurgical pencils
Device
EU MDD
·
Eu Md Class 2b
·Dongguan QueenMed Equipment Mfg Co Ltd·On the market·1 country
Electrosurgical pencils
Device
EU MDD
·
Eu Md Class 2b
·Dongguan QueenMed Equipment Mfg Co Ltd·On the market·1 country
Electrosurgical pencils
Device
EU MDD
·
Eu Md Class 2b
·Dongguan QueenMed Equipment Mfg Co Ltd·On the market·1 country
Electrosurgical pencils
Device
EU MDD
·
Eu Md Class 2b
·Dongguan QueenMed Equipment Mfg Co Ltd·On the market·1 country
Electrosurgical pencils
Device
EU MDD
·
Eu Md Class 2b
·Dongguan QueenMed Equipment Mfg Co Ltd·On the market·1 country
Electrosurgical pencils
Device
EU MDD
·
Eu Md Class 2b
·Dongguan QueenMed Equipment Mfg Co Ltd·On the market·1 country