Filler, Bone Void, Non-Osteoinduction

FDA Pre-Market Approval

FDA Class 3 ·COLLAGRAFT(TM) BONE GRAFT MATRIX

Filler, Bone Void, Non-Osteoinduction

FDA Pre-Market Approval

FDA Class 3 ·NEUGRAFT

Filler, Bone Void, Non-Osteoinduction

FDA Pre-Market Approval

FDA Class 3 ·COLLAGRAFT(TM) BONE GRAFT SUBSTITUTE

Aortic Valve, Prosthesis, Percutaneously Delivered

FDA Pre-Market Approval

FDA Class 3 ·Ascendra+ Delivery System; Balloon Aortic Valvuloplasty Catheter; NovaFlex+ Delivery System; Crimper; Edwards Ballon Cat

Fluid, Intraocular

FDA Pre-Market Approval

FDA Class 3 ·PERFLUORON (PURIFIED PERFLUORO-N-OCTANE LIQUID)

Cardiac Ablation Percutaneous Catheter

FDA Pre-Market Approval

FDA Class 3 ·Blazer II Cardiac Ablation System

Catheter, Coronary, Atherectomy

FDA Pre-Market Approval

FDA Class 3 ·Rotablator Rotational Angioplasty System Guidewire

Cardiac Ablation Percutaneous Catheter

FDA Pre-Market Approval

FDA Class 3 ·Chilli II Cooled RF Ablation system

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

FDA Pre-Market Approval

FDA Class 3 ·Blazer II XP Cardiac RF Ablation System

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

FDA Pre-Market Approval

FDA Class 3 ·Blazer Open Irrigated Cardiac Ablation System

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

FDA Pre-Market Approval

FDA Class 3 ·Wolverine Coronary Cutting Balloon (Monorail and Over-The-Wire)

Stent, Renal

FDA Pre-Market Approval

FDA Class 3 ·Express SD Monorail Premounted Stent System

Stent, Coronary

FDA Pre-Market Approval

FDA Class 3 ·Rebel Platinum Chromium Coronary Stent System (Monorail and Over-the-Wire)

Coronary Drug-Eluting Stent

FDA Pre-Market Approval

FDA Class 3 ·Promus Premier Everolimus-Eluting Platinum Chromium Coronary Stent System

Agent, Absorbable Hemostatic, Collagen Based

FDA Pre-Market Approval

FDA Class 3 ·COLLASTAT ABSORBABLE COLLAGEN HEMOSTATIC AGENTS-MICROFIBRILLAR FORM, COLLASTAT ABSORABLE COLAGEN HEMOSTATIC SPONGE

Material, Dressing, Surgical, Polylactic Acid

FDA Pre-Market Approval

FDA Class 3 ·COLLACOTE,COLLATAPE,COLLAPLUG ABSORABLE COLLAGEN WOUND DRESS

Device, Dermal Replacement

FDA Pre-Market Approval

FDA Class 3 ·INTEGRA ARTIFICIAL SKIN DERMAL REGENERATION TEMPLATE

Agent, Absorbable Hemostatic, Collagen Based

FDA Pre-Market Approval

FDA Class 3 ·HELISTAT/HELITENE ABSORBABLE COLLAGEN HEMOSTATIC AGENTS

Cardiac Ablation Percutaneous Catheter

FDA Pre-Market Approval

FDA Class 3 ·CELSIUS RMT THERMOCCOL CAT, CELSIUS THERMOCCOL CATH NAVISTAR & RMT THERMOCOOL CATHS,THERMOCOOL SF, SMARTTOUCH& NAV CATH

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

FDA Pre-Market Approval

FDA Class 3 ·Electrophysiology Cable; SE-Safire TX, Catheter Extension Cable; Therapy 8mm, Thermistor, Dual 8, Safire TX Ablation Cat