Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Flutter

FDA Pre-Market Approval

FDA Class 3 ·INTELLATIP MIFI XP- ABLATION CATHETER AND BLAZER PRIME XP CATHETER

PHC Europe B.V.

Importer

🇳🇱 Netherlands·1 Manufacturer

Clear Guide CORE

FDA UDI

CLEAR GUIDE MEDICAL, INC.·B201CGCORE24MR0·The device is intended as a computer platform t...

Clear Guide CORE

FDA UDI

CLEAR GUIDE MEDICAL, INC.·B201CGCORE130·The device is intended as a computer platform t...

Clear Guide CORE

FDA UDI

CLEAR GUIDE MEDICAL, INC.·B201CGCORE240·The device is intended as a computer platform t...

Klic10 Blood Collection Accessories Set D

Basic UDI-DI

EU MDR · Eu Md Class 2a ·1 device

HSC-Medical GmbH

Importer

🇩🇪 Germany·3 Manufacturers

BTL Industries JSC

Importer

🇧🇬 Bulgaria

TigerView

FDA UDI

TELEVERE SYSTEMS, LLC·00851800007108·TigerView software version 8.4.1

TigerView

FDA UDI

TELEVERE SYSTEMS, LLC·00851800007085·TigerView software version 8.2

ExamVue PACS

FDA UDI

TELEVERE SYSTEMS, LLC·00851800007078·ExamVue PACS version 1.1 Build 81

TigerView

FDA UDI

TELEVERE SYSTEMS, LLC·00851800007061·TigerView software version 8.3

TigerView

FDA UDI

TELEVERE SYSTEMS, LLC·00851800007009·TigerView Pro software version 7.7.13

TigerView

FDA UDI

TELEVERE SYSTEMS, LLC·00851800007023·TigerView Pro software version 7.7.3

TigerView

FDA UDI

TELEVERE SYSTEMS, LLC·00851800007016·TigerView 8.1 software Build 81

Prosthesis, Breast, Inflatable, Internal, Saline

FDA Pre-Market Approval

FDA Class 3 ·Spectrum Saline Breast Implants

LumiGuide Wire; LumiGuide Equipment R2.0; LumiGuide 3D Hub

FDA 510(k)

FDA Class 2 ·Cardiovascular

XPERCT REL. 3

FDA 510(k)

FDA Class 2 ·Radiology

Ingenia Elition and MR 7700 MR Systems

FDA 510(k)

FDA Class 2 ·Radiology

Philips IntelliSite Pathology Solution 5.1

FDA 510(k)

FDA Class 2 ·Pathology