491 results · 42ms · Sources: EU EUDAMED, US FDA

Analyzer, Medical Image

FDA Pre-Market Approval
FDA Class 2 ·SECONDLOOK (SL) CAD

Excimer Laser System

FDA Pre-Market Approval
FDA Class 3 ·WaveLight EX500 Laser System with Patient Bed Swivel 1125

Excimer Laser System

FDA Pre-Market Approval
FDA Class 3 ·WaveLight EX500 Laser System with Patient Bed Swivel 1125

Analyzer, Medical Image

FDA Pre-Market Approval
FDA Class 2 ·SECOND LOOK ANALOG 6.0 COMPUTER-AIDED DETECTION SYSTEM FOR MAMMOGRAPHY

Analyzer, Medical Image

FDA Pre-Market Approval
FDA Class 2 ·IMAGECHECKER CAD

Excimer Laser System

FDA Pre-Market Approval
FDA Class 3 ·WaveLight EX500 Laser System with Patient Bed Swivel 1125

Excimer Laser System

FDA Pre-Market Approval
FDA Class 3 ·WaveLight EX500 Laser System with Patient Bed Swivel 1125

System, Test, Carcinoembryonic Antigen

FDA Pre-Market Approval
FDA Class 2 ·ABBOTT CEA-EIA

Analyzer, Medical Image

FDA Pre-Market Approval
FDA Class 2 ·SECONDLOOK (SL) CAD

Analyzer, Medical Image

FDA Pre-Market Approval
FDA Class 2 ·IMAGE CHECKER CAD

Analyzer, Medical Image

FDA Pre-Market Approval
FDA Class 2 ·MAMMOGRAPHY CAD ENGINE

System, Test, Carcinoembryonic Antigen

FDA Pre-Market Approval
FDA Class 2 ·CEA-RIA MONOCLONAL

System, Test, Carcinoembryonic Antigen

FDA Pre-Market Approval
FDA Class 2 ·ABBOTT CEA-EIA

FDA Pre-Market Approval
SYNGO LUNG CAD

System, Test, Carcinoembryonic Antigen

FDA Pre-Market Approval
FDA Class 2 ·ABBOTT CEA-EIA

Excimer Laser System

FDA Pre-Market Approval
FDA Class 3 ·WAVELIGHT EX500 EXCIMER LASER SYSTEM

Excimer Laser System

FDA Pre-Market Approval
FDA Class 3 ·WAVELIGHT EX500 EXCIMER LASER SYSTEM

Pulse Generator, Pacemaker, Implantable, With Cardiac Resynchronization (Crt-P)

FDA Pre-Market Approval
FDA Class 3 ·Level VIII Controlled Environment Area (CEA), Level IX CEA Dry Room

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval
FDA Class 3 ·Level VIII Controlled Environment Area (CEA), Level IX CEA Dry Room

Implantable Pulse Generator, Pacemaker (Non-Crt)

FDA Pre-Market Approval
FDA Class 3 ·Level VIII Controlled Environment Area (CEA), Level IX CEA Dry Room