NEOCLOSE HASSON, NEOCLOSE UNIVERSAL

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

KNEEHAB XP

FDA 510(k)

FDA Class 2 ·Neurology

SLEEK OTW PTA CATHETER

FDA 510(k)

FDA Class 2 ·Cardiovascular

EVOLUTION COLONIC STENT SYSTEM

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

PRELUDE PLASTIC JACKETED GUIDE WIRE

FDA 510(k)

FDA Class 2 ·Cardiovascular

MERIT MARQUIS FLOW SWITCH

FDA 510(k)

FDA Class 2 ·Cardiovascular

NEUROTECH PLUS

FDA 510(k)

FDA Class 2 ·Neurology

AVIVAFIX CONDUCTIVE GARMENT-KNEE/SHOULDER/UPPER BACK, TYPE 40

FDA 510(k)

FDA Class 2 ·Neurology

CHARTER GUIDEWIRE MODEL 45-281, 45-282, 45-283

FDA 510(k)

FDA Class 2 ·Cardiovascular

VICTORY GUIDEWIRE (32 MODELS)

FDA 510(k)

FDA Class 2 ·Cardiovascular

COLLACARE DENTAL

FDA 510(k)

FDA Unclassified ·Unknown

DIGITAL PRINTER P6000D SERIES, MODEL P6000DU

FDA 510(k)

FDA Class 2 ·Radiology

Aplio i900/i800/i700 Diagnostic Ultrasound System, Software V8.5

FDA 510(k)

FDA Class 2 ·Radiology

Test, Hepatitis B (B Core, Be Antigen, Be Antibody, B Core Igm)

FDA Pre-Market Approval

FDA Class 3 ·VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HBC REAGENT PACK AND CALIBRATOR

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)

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 REGLUX MANAGEMENT SYSTEM

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 ·ANGELCHIK ANTI-REFLUX PROSTHESIS

Implant, Anti-Gastroesophageal Reflux

FDA Pre-Market Approval

FDA Class 3 ·LINX REFLUX MANAGEMENT SYSTEM