1,649 results · 51ms · Sources: EU EUDAMED, US FDA

Artificial Iris

FDA Pre-Market Approval
FDA Class 3 ·CustomFlex Artificial Iris

Artificial Iris

FDA Pre-Market Approval
FDA Class 3 ·CustomFlex ArtificialIris

Artificial Iris

FDA Pre-Market Approval
FDA Class 3 ·CustomFlex Artificial Iris

Artificial Iris

FDA Pre-Market Approval
FDA Class 3 ·CustomFlex Artificial Iris

Stimulator, Bone Growth, Non-Invasive

FDA Pre-Market Approval
FDA Class 3 ·Xstim Spine Fusion Stimulator

Stimulator, Bone Growth, Non-Invasive

FDA Pre-Market Approval
FDA Class 3 ·Xstim Spine Fusion Stimulator

Lenses, Soft Contact, Daily Wear

FDA Pre-Market Approval
FDA Class 2 ·OPTECH FRE-FLEX SOFT CONTACT LENS

Lenses, Soft Contact, Daily Wear

FDA Pre-Market Approval
FDA Class 2 ·OPTECH FRE-FLEX SOFT CONTACT LENS

Catheters, Transluminal Coronary Angioplasty, Percutaneous

FDA Pre-Market Approval
FDA Class 2 ·FIRE STAR RX PTCA BALLOON DILATATION CATHETER

Catheters, Transluminal Coronary Angioplasty, Percutaneous

FDA Pre-Market Approval
FDA Class 2 ·FIRE STAR RX PTCA BALLOON DILATATION CATHETER

FDA Pre-Market Approval
TOUCH® CMC 1 Prosthesis

Catheters, Transluminal Coronary Angioplasty, Percutaneous

FDA Pre-Market Approval
FDA Class 2 ·PTCA DILATATION & FIRE STAR RX PTCA BALLOON DILATATION CATHETERS

Catheters, Transluminal Coronary Angioplasty, Percutaneous

FDA Pre-Market Approval
FDA Class 2 ·FIRE STAR RX PTCA & DURA STAR RX PTCA BALLOON DILATATION CATHETER

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

FDA Pre-Market Approval
FDA Class 3 ·FlexAbility Ablation Catheter, Sensor Enabled (Bi-Directional) & FlexAbility Ablation Catheter, Sensor Enabled (Uni-Dire

Assays To Detect Pre-Existing Antibodies To Adeno-Associated Virus (Aav) Viral Vectors

FDA Pre-Market Approval
FDA Class 3 ·AAV5 DetectCDx®

Assays To Detect Pre-Existing Antibodies To Adeno-Associated Virus (Aav) Viral Vectors

FDA Pre-Market Approval
FDA Class 3 ·AAV5 DetectCDx

Prostate-Specific Antigen (Psa) For Management Of Prostate Cancers

FDA Pre-Market Approval
FDA Class 2 ·ACS:180(TM)/ADVIA CENTAUR(TM) PSA ASSAY

Coronary Drug-Eluting Stent

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

Coronary Drug-Eluting Stent

FDA Pre-Market Approval
FDA Class 3 ·ENDEAVOR SPRINT ZOTAROLIMUS-ELUTING CORONARY STENT SYSTEM

Stent, Coronary

FDA Pre-Market Approval
FDA Class 3 ·INTEGRITY CORONARY STENT SYSTEMS