10,000 results
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52ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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Senographe Pristina, Pristina Serena, and Pristina Serena 3D. for screening and diagnostic mammography
FDA Recall
Open, Classified
·GE Medical Systems, LLC·Product code MUE·October 24, 2025
GE Healthcare Innova X-ray Imaging Systems. The Digital Fluoroscopic Imaging System is indicated for use in diagnostic and interventional angiographic procedures of human anatomy. It is intended to replace image intensifier fluoroscopic systems in all diagnostic or interventional procedures. This device is not intended for mammography applications.
FDA Recall
Terminated
·GE Healthcare, LLC·Product code IZI·May 4, 2011
BD Bactec Blood Culture Procedural Tray, Cat. Number 442805 Becton, Dickinson and Company, 7 Loveton Circle, Sparks, MD 21152 Used in conjunction with the blood collection system.
FDA Recall
Terminated
·Becton Dickinson & Company·Product code JGE·April 22, 2011
Turbidimetric Method, Globulin
FDA classification
FDA Class 1
·Turbidimetric Method, Globulin
(1) GE Centricity Universal Viewer 6.0, Model 2088026-9XX; (2) GE Centricity Universal Viewer 7.0, Model 5826659-0XX; (3) GE Universal Viewer 8.0, Model 5865740-00x.
FDA Enforcement
Class II
·Ongoing·GE Healthcare, LLC·August 31, 2022
(1) GE Centricity Universal Viewer 6.0, Model 2088026-9XX; (2) GE Centricity Universal Viewer 7.0, Model 5826659-0XX; (3) GE Universal Viewer 8.0, Model 5865740-00x.
FDA Recall
Open, Classified
·GE Healthcare, LLC·Product code LLZ·July 15, 2022
MADA MEDICAL PRODUCTS, INC.
FDA UDI
MADA MEDICAL PRODUCTS, INC·00815160020832·A device that is connected to an independent su...
CableAGE
FDA UDI
CAMBRIDGE INTERVENTIONAL LLC·00811746030783·Cable Adapter
DAUD JEE MFG CO
FDA registration
DAUD JEE MFG CO·36 products·🇵🇰 Pakistan
Digital Age Dental Laboratories, Ltd.
FDA registration
Digital Age Dental Laboratories, Ltd.·13 products·🇻🇳 Vietnam
C6-2GE Ultrasonic Transducer(FDA)
FDA UDI
Shenzhen Mindray Bio-Medical Electronics Co., Ltd.·06944904088310·
JIE GAO PLASTIC PRODUCTS CO., LTD.
FDA registration
JIE GAO PLASTIC PRODUCTS CO., LTD.·11 products·🇨🇳 China
SHENZHEN JIE BISHI TECHNOLOGY CO., LTD
FDA registration
SHENZHEN JIE BISHI TECHNOLOGY CO., LTD·19 products·🇨🇳 China
AGEE EXTERNAL FIXATOR
FDA 510(k)
FDA Class 2
·Orthopedic
Shenzhen Jie Zhong Lian Technology Co., Ltd.
FDA registration
Shenzhen Jie Zhong Lian Technology Co., Ltd.·17 products·🇨🇳 China
YI JIE(FUJIAN)ELECTRONICS TECHNOLOGY CO.,LTD
FDA registration
YI JIE(FUJIAN)ELECTRONICS TECHNOLOGY CO.,LTD·2 products·🇨🇳 China
YI HAO JIE OPTICS(SUZHOU)CO., LTD.
FDA registration
YI HAO JIE OPTICS(SUZHOU)CO., LTD.·1 product·🇨🇳 China
BAND-AGE ICE-BANDAGE
FDA 510(k)
FDA Class 2
·Physical Medicine
Butterfly Gestational Age Tool
FDA 510(k)
FDA Class 2
·Radiology
AGEE-WRISTJACK PRE-DRILL KIT
FDA 510(k)
FDA Class 1
·Orthopedic