Test, Urea Adult And Pediatric (Breath),

FDA Pre-Market Approval

FDA Class 3 ·BreathTek UBT for H.pylori Kit (BreathTek UBT Kit), Pediatric Urea Hydrolysis Rate Calculation Application (pUHR-CA)

Stimulator, Neuromuscular, Implanted

FDA Pre-Market Approval

FDA Class 3 ·NEUROCONTROL FREEHAND SYSTEM

Surgical Cardiac Ablation Device, For Treatment Of Atrial Fibrillation

FDA Pre-Market Approval

FDA Class 3 ·ATRICURE SYNERGY ABLATION SYSTEM

Test, Urea Adult And Pediatric (Breath),

FDA Pre-Market Approval

FDA Class 3 ·BREATHTEK UBT FOR H. PYLORI KIT AND PEDIATRIC UREA HYDROLYSIS RATE CALCULATION APPLICATION (PUHR-CA), VERSION 1.0

Surgical Cardiac Ablation Device, For Treatment Of Atrial Fibrillation

FDA Pre-Market Approval

FDA Class 3 ·Synergy Ablation System

Monitor, Carbon-Dioxide, Cutaneous

FDA Pre-Market Approval

FDA Class 2 ·RADIOMETER TCM-10 TRANSCUTANEOUS CARBON DIOXIDE MO

Implant, Anti-Gastroesophageal Reflux

FDA Pre-Market Approval

FDA Class 3 ·LINX REFLUX MANAGEMENT SYSTEM

Test, Urea Adult And Pediatric (Breath),

FDA Pre-Market Approval

FDA Class 3 ·BREATH TEK UBT FOR H PYLORI KIT (BREATH TEK UBT KIT) AND PEDIATRIC UREA HYDROLYSIS RATE CALCULATION APPLICATION(PUHR-CA)

Test, Urea Adult And Pediatric (Breath),

FDA Pre-Market Approval

FDA Class 3 ·BREATH TEK UBTFOR H. PYLORI KIT

System, Nuclear Magnetic Resonance Imaging

FDA Pre-Market Approval

FDA Class 2 ·TESLACON(TM) NMR IMAGING SYSTEM

Accessories, Soft Lens Products

FDA Pre-Market Approval

FDA Class 2 ·MURINE LUBRICATING & REWETTING DROPS(CLEAR EYES )

Analyzer, Medical Image

FDA Pre-Market Approval

FDA Class 2 ·RAPIDSCREEN RS-2000D

Implant, Anti-Gastroesophageal Reflux

FDA Pre-Market Approval

FDA Class 3 ·LINX REFLUX MANAGEMENT SYSTEM

Surgical Cardiac Ablation Device, For Treatment Of Atrial Fibrillation

FDA Pre-Market Approval

FDA Class 3 ·AtriCure Synergy Ablation System

Stimulator, Neuromuscular, Implanted

FDA Pre-Market Approval

FDA Class 3 ·NEUROCONTROL FREEHAND SYSTEM

Surgical Cardiac Ablation Device, For Treatment Of Atrial Fibrillation

FDA Pre-Market Approval

FDA Class 3 ·EPi-Sense Guided Coagulation System and EPi-Sense ST Coagulation System

Surgical Cardiac Ablation Device, For Treatment Of Atrial Fibrillation

FDA Pre-Market Approval

FDA Class 3 ·EPi-Sense and EPi-Sense ST Guided Coagulation System

System, Nuclear Magnetic Resonance Imaging

FDA Pre-Market Approval

FDA Class 2 ·NUCLEAR MAGNETIC RESONANCE SCANNER MODELS NMR 1000

Implant, Anti-Gastroesophageal Reflux

FDA Pre-Market Approval

FDA Class 3 ·Linx Reflux Management System

Implant, Anti-Gastroesophageal Reflux

FDA Pre-Market Approval

FDA Class 3 ·LINX Reflux Management System