5,837 results · 46ms · Sources: EU EUDAMED, 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