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

Lens, Contact (Rigid Gas Permeable), Extended Wear

FDA Pre-Market Approval
FDA Class 3 ·Paragon HDS® (paflufocon B), FluoroPerm® 151 (paflufocon D), Paragon HDS® 100 (paflufocon D) Rigid Gas Permeable Contac

Lens, Contact (Rigid Gas Permeable), Extended Wear

FDA Pre-Market Approval
FDA Class 3 ·PARAPERM E.W. BLUE RIGID GAS PERMEABLE CONTACT LEN

Lens, Contact (Rigid Gas Permeable), Extended Wear

FDA Pre-Market Approval
FDA Class 3 ·Paragon HDS100 and Fluoroperm 151 Rigid Gas Permeable Contact Lenses in clear and tints

Lens, Contact (Rigid Gas Permeable), Extended Wear

FDA Pre-Market Approval
FDA Class 3 ·Boston Equalens (itafluorofocon A) Rigid Gas Permeable Contact Lens, Boston Equalens II (oprifocon A) Rigid Gas Permeabl

Lens, Contact (Rigid Gas Permeable), Extended Wear

FDA Pre-Market Approval
FDA Class 3 ·BOSTON EQUALENS/EQUALENS II

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

Agent, Bulking, Injectable For Gastro-Urology Use

FDA Pre-Market Approval
FDA Class 3 ·CONTIGEN BARD COLLAGEN IMPLANT

Gases Used Within Eye To Place Pressure On Detached Retina

FDA Pre-Market Approval
FDA Class 3 ·ISPAN SULFUR HEXAFLUORIDE SF6 GAS

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

FDA Pre-Market Approval
FDA Class 3 ·FREEZOR MAX CARDIAC CRYOABLATION CATHETER

Gases Used Within Eye To Place Pressure On Detached Retina

FDA Pre-Market Approval
FDA Class 3 ·ISPAN SULFUR HEXAFLUORIDE SF6 GAS

Heart-Valve, Non-Allograft Tissue

FDA Pre-Market Approval
FDA Class 3 ·Epic™ Max Tissue Heart Valves

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

FDA Pre-Market Approval
FDA Class 3 ·FREEZOR MAX CARDIAC CRYOABLATION CATHETER

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

FDA Pre-Market Approval
FDA Class 3 ·Freezor Max Cardiac Cryoablation Catheter

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

FDA Pre-Market Approval
FDA Class 3 ·FREEZOR MAX CARDIAC CRYOBLATION CATHETERS

Gases Used Within Eye To Place Pressure On Detached Retina

FDA Pre-Market Approval
FDA Class 3 ·ISPAN TM PERFLUOROPROPANE (C3F8)GAS

Gases Used Within Eye To Place Pressure On Detached Retina

FDA Pre-Market Approval
FDA Class 3 ·ISPAN SULFUR HEXAFLUORIDE SF6 GAS

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

FDA Pre-Market Approval
FDA Class 3 ·Freezor MAX Cardiac Cryoablation Catheter

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

FDA Pre-Market Approval
FDA Class 3 ·FREEZOR MAX CARDIAC CRYOABLATION CATHETER

Implantable Pulse Generator, Pacemaker (Non-Crt)

FDA Pre-Market Approval
FDA Class 3 ·PULSAR/PULSAR MAX/ DISCOVERY/MERIDIAN