5,837 results
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46ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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EMIT CFA THYROXINE ASSAY
FDA 510(k)
FDA Class 2
·Clinical Chemistry
HENSON CFA 3000 CENTRAL VISUAL FIELD SCREENER
FDA 510(k)
FDA Class 1
·Ophthalmic
VITREA CT MULTI-CHAMBER CARDIAC FUNCTIONAL ANALYSIS (CFA)
FDA 510(k)
FDA Class 2
·Radiology
Instrusafe
FDA UDI
Summit Medical, Inc.·00385640008129·
Curaway
FDA UDI
Zhejiang CuraWay Medical Technology Co., Ltd.·06936666559290·Endovenous Radiofrequency Catheter
Curaway
FDA UDI
Zhejiang CuraWay Medical Technology Co., Ltd.·06936666559313·Endovenous Radiofrequency Catheter
MedSource Blood Control Kit
FDA UDI
MEDSOURCE INTERNATIONAL LLC·00840155404168·Stop the Bleed Level 1 Kit
Curaway
FDA UDI
Zhejiang CuraWay Medical Technology Co., Ltd.·06936666559283·Endovenous Radiofrequency Catheter
MedSource Blood Control Kit
FDA UDI
MEDSOURCE INTERNATIONAL LLC·00840155404144·Stop the Bleed Level 2 Kit
Curaway
FDA UDI
Zhejiang CuraWay Medical Technology Co., Ltd.·06936666559306·Endovenous Radiofrequency Catheter
Curaway
FDA UDI
Zhejiang CuraWay Medical Technology Co., Ltd.·06936666559276·Endovenous Radiofrequency Catheter
MedSource Blood Control Kit
FDA UDI
MEDSOURCE INTERNATIONAL LLC·00840155404182·Bleeding Control Kit
MedSource Blood Control Kit
FDA UDI
MEDSOURCE INTERNATIONAL LLC·00840155404113·Stop the Bleed Level 3 Kit
Instrusafe
FDA UDI
Summit Medical, Inc.·00385640008358·
CARDIAC FUNCTIONAL ANALYSIS (CFA)
FDA Adverse Event
Malfunction
·VITAL IMAGES, INC.·Product code LLZ·March 12, 2013
EVOLUT PRO TRANSCATHETER AORTIC VALVE
FDA Adverse Event
Malfunction
·MEDTRONIC HEART VALVES DIVISION·Product code NPT·February 19, 2024
ROTAREXS 8F 110CM (STRAUB MEDICAL)
FDA Adverse Event
Injury
·STRAUB MEDICAL AG·Product code MCW·July 7, 2020
DIAMONDBACK 360 ORBITAL ATHERECTOMY SYSTEM
FDA Adverse Event
Injury
·CARDIOVASCULAR SYSTEMS INCORPORATED·Product code MCW·May 24, 2012
LUTONIX 035 DRUG COATED BALLOON PTA CATHETER
FDA Adverse Event
Injury
·C.R. BARD, INC. (GFO)·Product code ONU·January 22, 2019
KIT, 14FR INTRODUCER, 13CM&25CM, STERILE
FDA Adverse Event
Injury
·ABIOMED, INC.·Product code DYB·October 29, 2025