Implant, Anti-Gastroesophageal Reflux

FDA Pre-Market Approval

FDA Class 3 ·LINX Reflux Management System

Stent, Superficial Femoral Artery

FDA Pre-Market Approval

FDA Class 3 ·GORE VIABAHN ENDOPROSTHESIS, GORE VIABAHN ENDOPROSTHESIS WITH HEPARIN BIOACTIVE

Excimer Laser System

FDA Pre-Market Approval

FDA Class 3 ·STAR S4 EXCIMER LASER SYSTEM WITH VARIABLE SPOT SCANNING (VSS) AND WAVESCAN WAVEFRONT SYSTEM

Pulse-Generator, Pacemaker, External

FDA Pre-Market Approval

FDA Class 2 ·MICRO-PACE MODEL 4580 DUAL-CHAMBER,DDD,TEMPORARY CARDIAC PACEMAKER

Cardiac Ablation Percutaneous Catheter

FDA Pre-Market Approval

FDA Class 3 ·CHILLI COOLED ABLATION SYSTEM

Digital Breast Tomosynthesis

FDA Pre-Market Approval

FDA Class 3 ·SELENIA DIMENSIONS 3D SYSTEM

Heart-Valve, Mechanical

FDA Pre-Market Approval

FDA Class 3 ·HALL (TM) EASY-FIT PROSTHETIC HEART VALVE

Intraocular Lens

FDA Pre-Market Approval

FDA Class 3 ·iSert® Pre-loaded System; IPURE Pre-loaded System; PreVue Pre-loaded System

Pulse Generator, Pacemaker, Implantable, With Cardiac Resynchronization (Crt-P)

FDA Pre-Market Approval

FDA Class 3 ·VISIONIST Cardiac Resynchronization Therapy Pacemaker (CRT-P) Devices

Stimulator, Intramuscular, Automatic

FDA classification

FDA Class 2 ·Stimulator, Intramuscular, Automatic

Surgical Film

FDA classification

FDA Class 2 ·Surgical Film

High Throughput Dna Sequencing For Hereditary Cancer Predisposition Assessment Test System.

FDA classification

FDA Class 2 ·High Throughput Dna Sequencing For Hereditary Cancer Predisposition Assessment Test System.

Mass Spectrometer For Clinical Multiplex Test Systems

FDA classification

FDA Class 2 ·Mass Spectrometer For Clinical Multiplex Test Systems

Test, System, Immunoassay, Lipoprotein-Associated Phospholipase A2

FDA classification

FDA Class 2 ·Test, System, Immunoassay, Lipoprotein-Associated Phospholipase A2

Real Time Nucleic Acid Amplification System

FDA classification

FDA Class 2 ·Real Time Nucleic Acid Amplification System

General Purpose Reagent

FDA classification

FDA Class 1 ·General Purpose Reagent

Drug-Eluting Percutaneous Transluminal Coronary Angioplasty Catheter

FDA classification

FDA Class 3 ·Drug-Eluting Percutaneous Transluminal Coronary Angioplasty Catheter

Excimer Laser System

FDA Pre-Market Approval

FDA Class 3 ·WAVELIGHT ALLEGRETTO WAVE EXCIMER LASER SYSTEM

Analyzer, Medical Image

FDA Pre-Market Approval

FDA Class 2 ·LOGICON CARIES DETECTOR

Excimer Laser System

FDA Pre-Market Approval

FDA Class 3 ·BAUSCH & LOMB TECHNOLAS 217Z ZYOPTIX SYSTEM FOR PERSONALIZED VISION CORRECTION