409 results · 28ms · Sources: EU EUDAMED, US FDA

Excimer Laser System

FDA Pre-Market Approval
FDA Class 3 ·VISX STAR S2 AND S3 EXCIMER LASER SYSTEM

Coronary Drug-Eluting Stent

FDA Pre-Market Approval
FDA Class 3 ·TAXUS EXPRESS2 PACLITAXEL-ELUTING CORONARY STENT SYSTEM

Coronary Drug-Eluting Stent

FDA Pre-Market Approval
FDA Class 3 ·Resolute Integrity Zotarolimus-Eluting Coronary Stent Systems

Coronary Drug-Eluting Stent

FDA Pre-Market Approval
FDA Class 3 ·Resolute Onyx Zotarolimus-Eluting Coronary Stent Systems

Lens, Intraocular, Accommodative

FDA Pre-Market Approval
FDA Class 3 ·CRYSTALENS MODEL AT-45 ACCOMMODATING INTRAOCULAR LENS (IOL)

Device, Hemostasis, Vascular

FDA Pre-Market Approval
FDA Class 3 ·Prostar XL 10F Percutaneous Vascular Surgical System

Catheter, Percutaneous Transluminal Coronary Angioplasty (Ptca), Cutting/Scoring

FDA Pre-Market Approval
FDA Class 3 ·AngioSculpt® Evo RX PTCA Scoring Balloon Catheter with Hydrophilic Coating (AngioSculpt Evo catheter)

Percutaneous Cardiac Ablation Catheter For Treatment Of Atrial Fibrillation With Irreversible Electroporation

FDA Pre-Market Approval
FDA Class 3 ·PulseSelect™ Pulsed Field Ablation (PFA) system

Stent, Coronary

FDA Pre-Market Approval
FDA Class 3 ·EXPRESS 2 CORNARY STENT SYSTEM

Device, Impotence, Mechanical/Hydraulic

FDA Pre-Market Approval
FDA Class 3 ·Titan Inflatable Penile Prosthesis (IPP)

System, Colorectal Neoplasia, Rna Markers And Hemoglobin Detection

FDA Pre-Market Approval
FDA Class 3 ·ColoSense

Intraocular Lens

FDA Pre-Market Approval
FDA Class 3 ·Collamer Intraocular Lens (CIOL)

Coronary Drug-Eluting Stent

FDA Pre-Market Approval
FDA Class 3 ·RESOLUTE INTEGRITY ZOTAROLIMUS-ELUTING CORONARY STENT SYSTEM

Lens, Intraocular, Phakic

FDA Pre-Market Approval
FDA Class 3 ·Visian Implantable Collamer Lens (ICL)

Device, Hemostasis, Vascular

FDA Pre-Market Approval
FDA Class 3 ·Vascular Closure System (VCS)-VASCADE 5F Vascular Closure System, VASCADE 6/7F Vascular Closure System, VASCADE MVP Veno

Excimer Laser System

FDA Pre-Market Approval
FDA Class 3 ·VISX STAR S2 EXCIMER LASER SYSTEM

Defibrillator, Implantable, Dual-Chamber

FDA Pre-Market Approval
FDA Class 3 ·Implantable Cardioverter Defibrillator ICDs

Implant, Cochlear

FDA Pre-Market Approval
FDA Class 3 ·NUCLEUS 24 COCHLEAR IMPLANT SYSTEM

Coronary Drug-Eluting Stent

FDA Pre-Market Approval
FDA Class 3 ·ORSIRO Sirolimus Eluting Coronary Stent System

Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Ceramic/Metal, Cemented Or Uncemented

FDA Pre-Market Approval
FDA Class 3 ·Osteonics ABC/Trident System