Filler, Bone Void, Synthetic Peptide

FDA Pre-Market Approval

FDA Class 3 ·i-FACTOR® Peptide Enhanced Bone Graft

Stent, Coronary

FDA Pre-Market Approval

FDA Class 3 ·NIRFLEX PREMOUNTED CORONARY STENT SYSTEM

Stimulator, Ultrasound And Muscle, For Use Other Than Applying Therapeutic Deep

FDA Pre-Market Approval

FDA Class 3 ·EXOGEN ULTRASOUND BONE HEALING SYSTEM

System, Hyperthermia, Rf/Microwave (Benign Prostatic Hyperplasia),Thermotherapy

FDA Pre-Market Approval

FDA Class 3 ·UROLOGIX TARGIS(TM) SYSTEM

Stimulator, Ultrasound And Muscle, For Use Other Than Applying Therapeutic Deep

FDA Pre-Market Approval

FDA Class 3 ·EXOGEN 3000 SONIC ACCELERATED FRACTURE HEALING SYSTEM

Ablation System, High Intensity Focused Ultrasound (Hifu), Mr-Guided

FDA Pre-Market Approval

FDA Class 3 ·EXABLATE DEVICE

Aid, Surgical, Viscoelastic

FDA Pre-Market Approval

FDA Class 3 ·BIOLON (1% SODIUM HYALURONATE FOR OPHTHALMIC SURGERY)

Intraocular Lens

FDA Pre-Market Approval

FDA Class 3 ·STYLES 30 & 31 POSTERIOR CHAMBER IOLS

Coronary Drug-Eluting Stent

FDA Pre-Market Approval

FDA Class 3 ·EluNIR™ Ridaforolimus Eluting Coronary Stent System

Intraocular Lens

FDA Pre-Market Approval

FDA Class 3 ·3M VISION CARE POSTERIOR CHAMBER IOL,PERSPEX CQ-UV

Intraocular Lens

FDA Pre-Market Approval

FDA Class 3 ·STYLES 30 & 31 POSTERIOR CHAMBER IOLS

System, Endovascular Graft, Aortic Aneurysm Treatment

FDA Pre-Market Approval

FDA Class 3 ·AFX ENDOVASCULAR AAA SYSTEM

System, Endovascular Graft, Aortic Aneurysm Treatment

FDA Pre-Market Approval

FDA Class 3 ·POWERLINK SYSTEM WITH INTUITRAK DELIVERY SYSTEM

System, Endovascular Graft, Aortic Aneurysm Treatment

FDA Pre-Market Approval

FDA Class 3 ·OVATION ABDOMINAL STENT GRAFT SYSTEM

System, Endovascular Graft, Aortic Aneurysm Treatment

FDA Pre-Market Approval

FDA Class 3 ·Alto Abdominal Stent Graft System

Hybrid Stent Graft, Thoracic Aortic Lesion Treatment

FDA Pre-Market Approval

FDA Class 3 ·Thoraflex™ Hybrid

Laparoscopic Contraceptive Tubal Occlusion Device

FDA Pre-Market Approval

FDA Class 3 ·FEMCARE FILSHIE CLIP

Aid, Surgical, Viscoelastic

FDA Pre-Market Approval

FDA Class 3 ·BIOLON

Stent, Coronary

FDA Pre-Market Approval

FDA Class 3 ·NIRXCELL COCR CORNARY STENT ON RX

Stent, Coronary

FDA Pre-Market Approval

FDA Class 3 ·NIRxcell CoCr Coronary Stent on RX System