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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