48 results · 17ms · Sources: EU EUDAMED, US FDA

Phakic Toric Intraocular Lens

FDA Pre-Market Approval
FDA Class 3 ·Visian Toric ICL (IMPLANTABLE COLLAMER LENS)

Phakic Toric Intraocular Lens

FDA classification
FDA Class 3 ·Phakic Toric Intraocular Lens

Drug-Eluting Peripheral Transluminal Angioplasty Catheter

FDA Pre-Market Approval
FDA Class 3 ·IN.PACT 018 Paclitaxel-Coated Percutaneous Transluminal Angioplasty (PTA) Balloon Catheter

Drug-Coated Peripheral Transluminal Angioplasty Catheter

FDA Pre-Market Approval
FDA Class 3 ·IN.PACT AV Paclitaxel-Coated Percutaneous Transluminal Angioplasty (PTA) Balloon Catheter

Drug-Coated Peripheral Transluminal Angioplasty Catheter

FDA Pre-Market Approval
FDA Class 3 ·Lutonix Drug Coated Balloon PTA Catheter

Drug-Coated Peripheral Transluminal Angioplasty Catheter

FDA Pre-Market Approval
FDA Class 3 ·IN.PACT AV DCB

Drug-Eluting Peripheral Transluminal Angioplasty Catheter

FDA Pre-Market Approval
FDA Class 3 ·IN.PACT Admiral DCB

Drug-Eluting Peripheral Transluminal Angioplasty Catheter

FDA Pre-Market Approval
FDA Class 3 ·IN.PACT ADMIRAL DCB

Drug-Coated Peripheral Transluminal Angioplasty Catheter

FDA Pre-Market Approval
FDA Class 3 ·IN.PACT AV DCB

Drug-Coated Peripheral Transluminal Angioplasty Catheter

FDA Pre-Market Approval
FDA Class 3 ·IN.PACT AV DCB

Drug-Eluting Peripheral Transluminal Angioplasty Catheter

FDA Pre-Market Approval
FDA Class 3 ·IN.PACT Admiral DCB

Drug-Coated Peripheral Transluminal Angioplasty Catheter

FDA Pre-Market Approval
FDA Class 3 ·IN.PACT AV Paclitaxel-Coated Percutaneous Transluminal Angioplasty (PTA) Balloon Catheter

Drug-Eluting Peripheral Transluminal Angioplasty Catheter

FDA Pre-Market Approval
FDA Class 3 ·IN.PACT Admiral Paclitaxel-Coated Percutaneous Transluminal Angioplasty Balloon Catheter

Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Flutter

FDA Pre-Market Approval
FDA Class 3 ·Maestro™ Ablation Connection Box, IntellaNav™ XP and IntellaNav™ MiFi XP

Drug-Eluting Peripheral Transluminal Angioplasty Catheter

FDA Pre-Market Approval
FDA Class 3 ·LUTONIX DRUG COATED BALLOON (DCB)

Drug-Eluting Peripheral Transluminal Angioplasty Catheter

FDA Pre-Market Approval
FDA Class 3 ·LUTONIX DRUG COATED BALLOON (DCB)

Drug-Eluting Peripheral Transluminal Angioplasty Catheter

FDA Pre-Market Approval
FDA Class 3 ·IN.PACT™ Admiral™ Paclitaxel-Coated Percutaneous Transluminal Angioplasty (PTA) Balloon Catheter

Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Flutter

FDA Pre-Market Approval
FDA Class 3 ·Maestro™ Ablation Connection Box, IntellaNav™ OI

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval
FDA Class 3 ·VIRTUOSO & ENTRUST

Drug-Eluting Peripheral Transluminal Angioplasty Catheter

FDA Pre-Market Approval
FDA Class 3 ·Lutonix 035 DCB PTA Catheter Balloon