16 results · 16ms · Sources: EU EUDAMED, US FDA

Stent, Coronary

FDA Pre-Market Approval
FDA Class 3 ·MICRO STENT TM II, MICRO STENT TM II XL, GFX TM, GFX TM XL

Stent, Coronary

FDA Pre-Market Approval
FDA Class 3 ·MICRO STENT TM II, MICRO STENT TM II XL, GFX TM, GFX TM XL

Enzyme Immunoassay, Fetal Fibronectin

FDA Pre-Market Approval
FDA Class 3 ·Rapid fFN for the TLiIQ System

Stent, Coronary

FDA Pre-Market Approval
FDA Class 3 ·GFX-XP/GFX2 CORONARY STENT SYSTEM

Enzyme Immunoassay, Fetal Fibronectin

FDA Pre-Market Approval
FDA Class 3 ·Rapid fFN for the TLiIQ System

Stent, Coronary

FDA Pre-Market Approval
FDA Class 3 ·GFX OVER-THE-WIRE CORONARY STENT SYSTEM

Enzyme Immunoassay, Fetal Fibronectin

FDA Pre-Market Approval
FDA Class 3 ·Rapid fFN for the TLilQ System

Stent, Coronary

FDA Pre-Market Approval
FDA Class 3 ·GFX 2 OVER-THE-WIRE CORONARY STSENT SYSTEM

Stent, Coronary

FDA Pre-Market Approval
FDA Class 3 ·GFX SL OVER-THE-WIRE CORONARY STENT SYSTEM

Stent, Coronary

FDA Pre-Market Approval
FDA Class 3 ·MICRO STENT II & GFX OVER-THE-WIRE CORONARY STENT SYSTEMS

Stent, Coronary

FDA Pre-Market Approval
FDA Class 3 ·MICRO STENT II & GFX OVER-THE-WIRE CORONARY STENT SYSTEMS

Stent, Coronary

FDA Pre-Market Approval
FDA Class 3 ·GFX & MICRO STENT II OVER-THE-WIRE CORONARY STENT SYSTEM

Stent, Coronary

FDA Pre-Market Approval
FDA Class 3 ·MICRO STENT II OVER-THE-WIRE CORONARY STENT SYSTEM;GFX OVER-THE-WIRE CORONARY STENT SYSTEM

Stent, Coronary

FDA Pre-Market Approval
FDA Class 3 ·AVE MICRO STENT II OVER-THE-WIRE CORONARY STENT SYSTEM AND AVE GFX OVER-THE-WIRE CORONARY STENT SYSTEM

Somatic Gene Mutation Detection System

FDA Pre-Market Approval
FDA Class 3 ·Roche cobas EGFR Mutation Test, Roche cobas® DNA Sample Preparation Kit, cobas® EGFR Mutation Test v2, Roche cobas® cfD

Iliac Covered Stent, Arterial

FDA classification
FDA Class 3 ·Iliac Covered Stent, Arterial