508 results · 19ms · Sources: EU EUDAMED, US FDA

Coronary Drug-Eluting Stent

FDA Pre-Market Approval
FDA Class 3 ·CYPHER SIROLIMUS-ELUTING CORONARY STENT ON THE RAPTOR OVER-THE-WIRE DELIVERY SYSTEM OR RAPTORRAIL RAPID EXCHANGE DELIVER

Coronary Drug-Eluting Stent

FDA Pre-Market Approval
FDA Class 3 ·CYPHER SIROLIMUS-ELUTING CORONARY STENT ON THE RAPTOR OVER-THE-WIRE DELIVERY SYSTEM OR RAPTORRAIL RAPID EXCHANGE DELIVER

Coronary Drug-Eluting Stent

FDA Pre-Market Approval
FDA Class 3 ·CYPHER SIROLIMUS-ELUTING CORONARY STENT ON THE RAPTOR OVER-THE-WIRE DELIVERY SYSTEM OR RAPTORRAIL RAPID EXCHANGE DELIVER

Coronary Drug-Eluting Stent

FDA Pre-Market Approval
FDA Class 3 ·CYPHER SIROLIMUS-ELUTING CORONARY STENT ON THE RAPTOR OVER-THE-WIRE DELIVERY SYSTEM OR RAPTORRAIL RAPID EXCHANGE DELIVER

Hepatitis Viral B Dna Detection

FDA Pre-Market Approval
FDA Class 3 ·COBAS AmpliPrep/COBAS TaqMan HBV Test, v2.0 and COBAS TaqMan HBV Test for use on the High Pure System

Stent, Coronary

FDA Pre-Market Approval
FDA Class 3 ·BX VELOCITY BALLOON EXPANDABLE STENT WITH RAPTOR OTW DELIVERY SYSTEM AND BX VELOCITY STENT WITH HEPACOAT ON RAPTOR OTW

Hepatitis Viral B Dna Detection

FDA Pre-Market Approval
FDA Class 3 ·COBAS AmpliPrep/COBAS TaqMan HBV Test, v2.0 and COBAS TaqMan HBV Test for use on the High Pure System

Hepatitis Viral B Dna Detection

FDA Pre-Market Approval
FDA Class 3 ·COBAS TaqMan HBV Test for use on the High Pure System and COBAS AMpliPrep/COBAS TaqMan HBV Test, v2.0

Hepatitis Viral B Dna Detection

FDA Pre-Market Approval
FDA Class 3 ·COBAS AmpliPrep/COBAS TaqMan HBV Test, v2.0 and COBAS TaqMan HBV Test for use on the High Pure System

Stent, Coronary

FDA Pre-Market Approval
FDA Class 3 ·BX VELOCITY BALLOON-EXPANDABLE STENT WITH RAPTOR OVER THE WIRE DELIVERY SYSTEM/BX VELOCITY WITH HEPACOAT ON RAPTOR STENT

Test, Hepatitis B (B Core, Be Antigen, Be Antibody, B Core Igm)

FDA Pre-Market Approval
FDA Class 3 ·ELECSYS ANTI-HBC IGM IMMUNOASSAY & ELECSYS PREICONTROL ANTI-HBC IGM FOR USE ON THE MODULAR ANAYTICS E170 IMMUNOASSAY ANA

Test, Hepatitis B (B Core, Be Antigen, Be Antibody, B Core Igm)

FDA Pre-Market Approval
FDA Class 3 ·ELECSYS ANTI-HBC IGM IMMUNOASSAY & ELECSYS PREICONTROL ANTI-HBC IGM FOR USE ON THE MODULAR ANAYTICS E170 IMMUNOASSAY ANA

Stent, Coronary

FDA Pre-Market Approval
FDA Class 3 ·PHOSPHORYLCHOLINE (PC) COATED BIODIVYSIOH SV STENT PREMOUNTED ON AN OVER-THE-WIRE (OTW) DELIVERY SYST SV OTW), AND PC C)

Hepatitis Viral B Dna Detection

FDA Pre-Market Approval
FDA Class 3 ·Roche COBAS AmpliPrep/COBAS TaqMan HBV Test, v2.0 and COBAS TaqMan HBV Test for use on the High Pure System

Prosthesis, Hip, Semi-Constrained, Ceramic-On-Metal Articulation

FDA classification
FDA Class 3 ·Prosthesis, Hip, Semi-Constrained, Ceramic-On-Metal Articulation

Gases Used Within Eye To Place Pressure On Detached Retina

FDA classification
FDA Class 3 ·Gases Used Within Eye To Place Pressure On Detached Retina

Device, Antichoke, Suction

FDA classification
FDA Class 3 ·Device, Antichoke, Suction

Sterilizer, Endodontic Dry Heat

FDA classification
FDA Class 3 ·Sterilizer, Endodontic Dry Heat

Sterilizer, Glass Bead

FDA classification
FDA Class 3 ·Sterilizer, Glass Bead

Prosthesis, Testicle

FDA classification
FDA Class 3 ·Prosthesis, Testicle