5,105 results · 42ms · Sources: EU EUDAMED, US FDA

Heart-Valve, Non-Allograft Tissue

FDA Pre-Market Approval
FDA Class 3 ·3F AORTIC BIOPROSTHESIS

System, Photopheresis, Extracorporeal

FDA Pre-Market Approval
FDA Class 3 ·UVAR PHOTOPHORESIS SYSTEM

Heart-Valve, Non-Allograft Tissue

FDA Pre-Market Approval
FDA Class 3 ·HANCOCK I MODIFIED ORIFICE VALVED CONDUIT MODEL 150

Heart-Valve, Non-Allograft Tissue

FDA Pre-Market Approval
FDA Class 3 ·Trifecta™ Valve with Glide Technology™

Heart-Valve, Non-Allograft Tissue

FDA Pre-Market Approval
FDA Class 3 ·Trifecta Valve with Glide Technology (Trifecta GT) Trifecta Valve.

Heart-Valve, Non-Allograft Tissue

FDA Pre-Market Approval
FDA Class 3 ·HANCOCK MODIFIED ORIFICE BIOPROSTHESIS

Heart-Valve, Non-Allograft Tissue

FDA Pre-Market Approval
FDA Class 3 ·FREESTYLE AORTIC ROOT BIOPROSTHESIS

Heart-Valve, Non-Allograft Tissue

FDA Pre-Market Approval
FDA Class 3 ·EDWARDS INTUITY ELITE Valve System

Heart-Valve, Non-Allograft Tissue

FDA Pre-Market Approval
FDA Class 3 ·TRIFECTA VALVE

RheOx Generator

Device
EU MDD · Eu Md Class 2b ·Galvanize Therapeutics, Inc.·No longer on the market·5 countries

CENTAURI Connect

Device
EU MDR · Eu Md Class 1 ·Galvanize Therapeutics, Inc.·On the market·9 countries

CENTAURI Generator

Device
EU MDR · Eu Md Class 2b ·Galvanize Therapeutics, Inc.·On the market·9 countries

ECG Trunk Cable

Device
EU MDR · Eu Md Class 1 ·Galvanize Therapeutics, Inc.·On the market·9 countries

Compatibility Cable, BW ThermoCool ST

Device
EU MDR · Eu Md Class 1 ·Galvanize Therapeutics, Inc.·On the market·9 countries

RheOx Catheter

Device
EU MDD · Eu Md Class 2a ·Galvanize Therapeutics, Inc.·No longer on the market·5 countries

RheOx Catheter

Device
EU MDD · Eu Md Class 2a ·Galvanize Therapeutics, Inc.·No longer on the market·5 countries

HD 60147227 0001

Certificate
MDD Annex II Section 4·Shenzhen JCR Medical Technology Limited Company·TÜV Rheinland LGA Products GmbH·5 Basic UDI-DIs

Human BCR-ABL Gene T315I Mutation Detection Kit (Multiplex Fluorescence Polymerase Chain Reaction)

Basic UDI-DI
EU IVDD · Eu Ivd General ·XIAMEN SPACEGEN CO.,LTD.·1 device

Droplet Digital Pcr System

FDA classification
FDA Class 2 ·Droplet Digital Pcr System

Setter, Band, Orthodontic

FDA classification
FDA Class 1 ·Setter, Band, Orthodontic