HI TORQUE CONNECT GUIDEWIRE

FDA 510(k)

FDA Class 2 ·Cardiovascular

MERIT HYDROPHILIC GUIDE WIRE

FDA 510(k)

FDA Class 2 ·Cardiovascular

BMR FACE

FDA 510(k)

FDA Class 2 ·Neurology

Cathivex ¿GV filter units

FDA 510(k)

FDA Class 2 ·General Hospital

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

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

Acute Coronary Syndrome Event Detector

FDA Pre-Market Approval

FDA Class 3 ·AngelMed Guardian System

Reherniation Reduction Device

FDA Pre-Market Approval

FDA Class 3 ·Barricaid® Annular Closure Device