2,981 results
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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MAXIM 7000 QUADRATURE EXTREMITY COIL MODEL NUMBER QEC-GEM-15A
FDA 510(k)
FDA Class 2
·Radiology
BRAVO
FDA Adverse Event
Injury
·GIVEN IMAGING LTD., YOQNEAM·Product code FFT·December 9, 2019
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
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 Recall
Terminated
·GE Healthcare Beijing , Hangwei Medical Systems, Co. LTD
No. 2 Yong Chang North Rd.
Beijing Econ. & Tech. Dev. Zone
Beijing China·Product code OXO·September 18, 2013
Forceps, Biopsy, Electric Surgical Hemostasis Within Tracheobronchial Tree
FDA classification
FDA Class 2
·Forceps, Biopsy, Electric Surgical Hemostasis Within Tracheobronchial Tree
Gyrus ACMI
FDA UDI
Gyrus ACMI, LLC·00821925008502·INCLUDED IN AEH-4/AUTOCLAVE EXTEND CABLE
PMT® CORPORATION HALO
FDA UDI
PMT CORPORATION·00650551042976·1203-5 HALO VEST, PEDIATRIC 0, COOLMAX LINER
Cleaning Sponge
FDA UDI
Yangzhou Fartley Medical Instrument Technology Co., Ltd·06936603230978·Sentrus Cleaning Sponge, cleaning sponge (witho...
Multichem AEC
FDA UDI
TECHNO-PATH MANUFACTURING LIMITED·05391523442596·
AEC (Aminoethylcarbazole)
FDA UDI
BIOGENEX LABORATORIES·00850646007327·
Multichem AEC
FDA UDI
TECHNO-PATH MANUFACTURING LIMITED·05391523442572·
Multichem AEC
FDA UDI
TECHNO-PATH MANUFACTURING LIMITED·05391523442589·
A-dec, Inc.
FDA registration
A-dec, Inc.·24 products·🇺🇸 United States
Subdural Electrode
FDA UDI
Ad-Tech Medical Instrument Corporation·00841823103130·
A-BEC 41
FDA 510(k)
FDA Class 2
·Physical Medicine
A-BEC 47
FDA 510(k)
FDA Class 2
·Physical Medicine
AEC DETECTION KIT
FDA 510(k)
FDA Class 2
·Immunology
A-BEC 17
FDA 510(k)
FDA Class 2
·Physical Medicine
A-BEC 18
FDA 510(k)A-BEC 46
FDA 510(k)
FDA Class 2
·Physical Medicine