Lenses, Soft Contact, Extended Wear

FDA Pre-Market Approval

FDA Class 3 ·EQUATE ASPHERE (OCUFILCON D) SOFT (HYDROPHILIC) CONTACT LENSES, EQUATE TORIC (OCUFILCON D) SOFT (HYDROPHILIC) CONTACT LE

Kit, Dna Detection, Human Papillomavirus

FDA Pre-Market Approval

FDA Class 3 ·CERVISTA HPV HR AND GENFIND KIT

System, Endovascular Graft, Aortic Aneurysm Treatment

FDA Pre-Market Approval

FDA Class 3 ·RELAY THORACIC STENT-GRAFT WITH PLUS DELIVERY SYSTEM

Prosthesis, Intervertebral Disc

FDA Pre-Market Approval

FDA Class 3 ·MOBI-C CERVICAL DISC PROSTHESIS

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

FDA Pre-Market Approval

FDA Class 3 ·WOLVERINE CORONARY CUTTING BALLOON (MONORAIL AND OVER-THE-WIRE)

Stimulator, Electrical, Implanted, For Parkinsonian Tremor

FDA Pre-Market Approval

FDA Class 3 ·ACTIVA THERAPY FOR DBS

Implant, Dermal, For Aesthetic Use

FDA Pre-Market Approval

FDA Class 3 ·SCULPTRA AND SCULPTRA AESTHETIC

Reader, Cervical Cytology Slide, Automated

FDA Pre-Market Approval

FDA Class 3 ·THINPREP IMAGING SYSTEM

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

FDA Pre-Market Approval

FDA Class 3 ·MetriQ Irrigation Pump

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

FDA Pre-Market Approval

FDA Class 3 ·Arctic Front™ Cardiac Cryoablation Catheter System

System, Endovascular Graft, Aortic Aneurysm Treatment

FDA Pre-Market Approval

FDA Class 3 ·TALENT ABDOMINAL STENT GRAFT SYSTEM

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

FDA Pre-Market Approval

FDA Class 3 ·THERAPY DUAL 8 CATHETER

Shockwave Intravascular Lithotripsy System

FDA Pre-Market Approval

FDA Class 3 ·Shockwave Intravascular Lithotripsy (IVL) System with Shockwave C2 Coronary Intravascular Lithotripsy (IVL) Catheter

Catheter, Coronary, Atherectomy

FDA Pre-Market Approval

FDA Class 3 ·Rotational Atherectomy System

Stent, Carotid

FDA Pre-Market Approval

FDA Class 3 ·Enroute Transcarotid Stent System

Cardiac Ablation Percutaneous Catheter

FDA Pre-Market Approval

FDA Class 3 ·FLEXABILITY ABLATION CATHETER

Artificial Heart

FDA Pre-Market Approval

FDA Class 3 ·CARDIOWEST TEMPORARY TOTAL ARTIFICAL HEART (TAH-T) SYSTEM

Intracranial Aneurysm Flow Diverter

FDA Pre-Market Approval

FDA Class 3 ·Pipeline™ Vantage Embolization Device with Shield Technology™

Pulse Generator, Permanent, Implantable

FDA Pre-Market Approval

FDA Class 3 ·AFFINITY/INTEGRITY/VICTORY FAMILY OF PACEMAKERS

Valve, Pulmonary

FDA Pre-Market Approval

FDA Class 3 ·Pulmonx Zephyr Endobronchial Valve (EBV)