3D ASL

FDA 510(k)

FDA Class 2 ·Radiology

MIVI Mi-AXUS Guide Catheter

FDA 510(k)

FDA Class 2 ·Cardiovascular

VersaD Delivery Catheter

FDA 510(k)

FDA Class 2 ·Cardiovascular

Solo-Dex Fascile Continuous Peripheral Nerve Block Catheter and Needle Kit

FDA 510(k)

FDA Class 2 ·Anesthesiology

2-Way 100% Silicone ClearTract Catheter

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

2-Way 100% Silicone Cleartract Catheter

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

2-Way 100% Silicone Cleartract Catheter

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

MEDI-STIM BUTTERFLY FLOWMETER, MODEL BF1000-BF2004

FDA 510(k)

FDA Class 2 ·Radiology

ODI-Tech

FDA 510(k)

FDA Class 2 ·Cardiovascular

SKIFA, PLASTIC DISPOSABLE SYRINGE

FDA 510(k)

FDA Class 2 ·General Hospital

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·Accessory Medical Adhesive, Accessory Mineral Oil, Accessory Vein Pick, Accessory Kit Lead Cap, Accessory Stylet TAPER 0

Stent, Superficial Femoral Artery

FDA Pre-Market Approval

FDA Class 3 ·LIFESTENT VASCULAR STENT SYSTEMS

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·MEDTRONIC AT500 DDDRP PACING SYSTEM

Coronary Drug-Eluting Stent

FDA Pre-Market Approval

FDA Class 3 ·TAXUS LIBERTE ATOM PACLITAXEL-ELUTING CORONARY STENT SYSTEM

Intraocular Lens

FDA Pre-Market Approval

FDA Class 3 ·TECNIS TORIC 1-PIECE INTRAOCULAR LENS

Intraocular Lens

FDA Pre-Market Approval

FDA Class 3 ·ACRYSOF IQ TORIC INTAOCULAR LENS

Drug-Eluting Peripheral Transluminal Angioplasty Catheter

FDA Pre-Market Approval

FDA Class 3 ·LUTONIX 035 DRUG COATED BALLOON PTA CATHETER

Coronary Drug-Eluting Stent

FDA Pre-Market Approval

FDA Class 3 ·ION PACLITAXEL-ELUTING PLATINUM CHRONIUM CORONARY STENT SYSTEM

Transcatheter Septal Occluder

FDA Pre-Market Approval

FDA Class 3 ·AMPLATZER MUSCULAR VSD OCCLUDER

Coronary Drug-Eluting Stent

FDA Pre-Market Approval

FDA Class 3 ·ENDEAVOR ZOTAROLIMUS-ELUTING CORONARY STENT SYSTEM