CORGRIP NG/NI Tube Retention System

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

PTS Professional Chemistry Kit

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

AMStent® Tracheobronchial Covered Stent System

FDA 510(k)

FDA Class 2 ·Anesthesiology

WIDEXLINK IN CLEAR SERIES HEARING AIDS

FDA 510(k)

FDA Class 2 ·Ear, Nose, Throat

4 SURE TM ENEMA BAG SET

FDA 510(k)

FDA Class 1 ·Gastroenterology, Urology

DESERET(R) FLOW RESTRICTION VALVE

FDA 510(k)

FDA Class 2 ·General Hospital

BARD LUMINEXX 3 BILIARY STENT AND DELIVERY SYSTEM

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

TRIGLYCERIDE ASSAY KIT-COLORIMETRIC

FDA 510(k)

NvisionVLE Imaging System, NvisionVLE Optical Probe, NvisionVLE Inflation Accessory

FDA 510(k)

FDA Class 2 ·Radiology

ipsogen JAK2 RGQ PCR Kit

FDA 510(k)

FDA Class 2 ·Medical Genetics

SURGICAL INSTRUMENT KIT, DISPOSABLE

FDA 510(k)

FDA Class 1 ·General, Plastic Surgery

EVOLUTION BILIARY STENT SYSTEM

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

SHAWNEE PRODUCTS KIT II

FDA 510(k)

FDA Class 1 ·General Hospital

Viz HCM

FDA 510(k)

FDA Class 2 ·Cardiovascular

MODIFICIATION TO: BILIARY WALLSTENT ENDOPROSTHEIS WITH MONORAIL DELIVERY SYSTEM, MODEL 71-XXX

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

MAHURKAR ELITE ACUTE DUAL LUMEN CATHETER, ELITE ACUTE TRIPLE LUMEN CATHETER

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

Cure Catheter Insertion Kit (K1); Cure Catheter Insertion Kit (K2); Cure Catheter Insertion Kit (K2-90); Cure Catheter Insertion Kit (K3); Cure Hydrophilic Catheter Kit (HM12UK); Cure Hydrophilic Catheter Kit (HM14UK); Cure Hydrophilic Catheter Kit (HM16UK); Cure Pocket Catheter Kit (M14UK); Cure Catheter Closed System Kit (CS8); Cure Catheter Closed System Kit (CS10); Cure Catheter Closed System Kit (CS12); Cure Catheter Closed System Kit (CS14); Cure Catheter Closed System Kit (CS14C

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

EMERGENCY ROOM & MINOR OFFICE PROCEDURE CUSTOM KIT

FDA 510(k)

STRATIFY JCV(TM) ANTIBODY

FDA 510(k)

FDA Class 2 ·Microbiology

Mahurkar Acute Single Lumen Catheter, Mahurkar Acute Dual Lumen Catheter, Mahurkar Acute Triple Lumen Catheter, Mahurkar Acute High Pressure Triple Lumen Catheter

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology