3,559 results · 74ms · Sources: EU EUDAMED, US FDA

Analyzer, Medical Image

FDA Pre-Market Approval
FDA Class 2 ·SECOND LOOK DIGITAL COMPUTER-AIDED DETECTION SYSTEM

Stimulator, Electrical, Implanted, For Parkinsonian Symptoms

FDA Pre-Market Approval
FDA Class 3 ·Vercise Deep Brain Stimulation (DBS) Systems

Excimer Laser System

FDA Pre-Market Approval
FDA Class 3 ·VISX EXCIMER LASER SYSTEM MODEL C STAR

Fillauer Europe AB

Authorized representative
🇸🇪 Sweden·6 Manufacturers·4 Devices

MedPass SAS

Authorized representative
🇫🇷 France·13 Manufacturers·130 Devices

Philips Medical Systems Nederland B.V.

Authorized representative
🇳🇱 Netherlands·21 Manufacturers·1029 Devices

Defibrillator, Implantable, Dual-Chamber

FDA Pre-Market Approval
FDA Class 3 ·LUMAX FAMILY OF ICDS/CRT-DS

Defibrillator, Implantable, Dual-Chamber

FDA Pre-Market Approval
FDA Class 3 ·LUMAX FAMILY OF ICDS/CRT-DS

Pulse Generator, Permanent, Implantable

FDA Pre-Market Approval
FDA Class 3 ·LUMAX IMPLANTABLE CARDIOVERTER DEFIBRILLATORS (ICDS)

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval
FDA Class 3 ·LUMAX FAMILY OF ICDS/CRT-DS

System, Test, Her-2/Neu, Ihc

FDA Pre-Market Approval
FDA Class 3 ·PATHWAY ANTI-HER-2/NEU (4B5) PRIMARY ANTIBODY

ΤΖΙΒΕΛΕΚΑΣ ΚΩΝΣΤΑΝΤΙΝΟΣ ΜΟΝΟΠΡΟΣΩΠΗ ΕΤΑΙΡΙΑ ΠΕΡΙΟΡΙΣΜΕΝΗΣ ΕΥΘΥΝΗΣ

Importer
4 Manufacturers

Next Generation Sequencing Oncology Panel, Somatic Or Germline Variant Detection System

FDA Pre-Market Approval
FDA Class 3 ·FoundationFocus CDxBRCA

AS Semetron

Importer
🇪🇪 Estonia·5 Manufacturers

Ortho Organizers GmbH

Importer
🇩🇪 Germany·34 Manufacturers

P.J. Brennan & Company Limited

Importer
🇮🇪 Ireland·18 Manufacturers

System, Test, Her-2/Neu, Ihc

FDA Pre-Market Approval
FDA Class 3 ·PATHWAY HER-2/NEU (CLONE CD11) PRIMARY ANTIBODY

CORIN FRANCE SAS

Importer
🇫🇷 France·6 Manufacturers

System, Test, Tumor Marker, For Detection Of Bladder Cancer

FDA Pre-Market Approval
FDA Class 3 ·ALERE NMP22 URINE COLLECTION KIT

System, Test, Tumor Marker, For Detection Of Bladder Cancer

FDA Pre-Market Approval
FDA Class 3 ·ALERE NMP22 BLADDERCHECK TEST & CONTROL KIT