Prosthesis, Spinous Process Spacer/Plate

FDA Pre-Market Approval

FDA Class 3 ·Superion™ Indirect Decompression System (IDS)

Prosthesis, Ankle, Uncemented, Non-Constrained

FDA Pre-Market Approval

FDA Class 3 ·SCANDINAVIAN TOTAL ANKLE REPLACEMENT SYSTEM (STAR ANKLE)

Stent, Iliac

FDA Pre-Market Approval

FDA Class 3 ·ABSOLUTE PRO VASCULAR SELF-EXPANDING STENT SYSTEM

Stent, Iliac

FDA Pre-Market Approval

FDA Class 3 ·SMART NITINOL SYSTEM & SMART CONTROL NITINOL STENT SYSTEM

Stent, Iliac

FDA Pre-Market Approval

FDA Class 3 ·INTRASTENT DOUBLE STRUT STENT

Stent, Iliac

FDA Pre-Market Approval

FDA Class 3 ·WALLSTENT ENDOPROSTHESIS ILIAC

Stent, Iliac

FDA Pre-Market Approval

FDA Class 3 ·EXPRESS LD LLIAC PREMOUNTED STENT SYSTEM

Prosthesis, Ankle, Uncemented, Non-Constrained

FDA Pre-Market Approval

FDA Class 3 ·Hintermann Series H3 Total Ankle Replacement System

Lenses, Soft Contact, Extended Wear

FDA Pre-Market Approval

FDA Class 3 ·PRECISION(TM) UV (VASURFILCON)

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

Lens, Contact (Rigid Gas Permeable), Extended Wear

FDA Pre-Market Approval

FDA Class 3 ·MENICON Z RIGID GAS PERMEABLE CONTACT LENS

Lenses, Soft Contact, Extended Wear

FDA Pre-Market Approval

FDA Class 3 ·PURE VISION VISIBILITY TINTED CONTACT LENS FOR EXTENDED WEAR

Salivary Estriol Test

FDA Pre-Market Approval

FDA Class 3 ·SALEST TM SYSTEM

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

FDA Pre-Market Approval

FDA Class 3 ·Scoreflex NC Scoring PTCA Catheter

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

FDA Pre-Market Approval

FDA Class 3 ·Scoreflex NC Scoring PTCA Catheter

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

FDA Pre-Market Approval

FDA Class 3 ·Scoreflex NC Scoring PTCA Catheter

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

FDA Pre-Market Approval

FDA Class 3 ·Scoreflex NC

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

FDA Pre-Market Approval

FDA Class 3 ·Scoreflex NC Scoring PTCA Catheter

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

FDA Pre-Market Approval

FDA Class 3 ·Scoreflex NC Scoring PTCA Catheter