SILICONE IMPRESSION MATERIAL

FDA 510(k)

FDA Class 2 ·Dental

Connected OR Hub with Device and Voice Control; SDC4K Information Management System with Device and Voice Control

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

TURBO SUPPORT CATHETER

FDA 510(k)

FDA Class 2 ·Cardiovascular

STRYKER FLEXIBLE URETEROSCOPE

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

SUPER NOVA, ACUBEAM

FDA 510(k)

FDA Class 2 ·Physical Medicine

QUIDEL CH50 EQ EIA

FDA 510(k)

FDA Class 2 ·Immunology

SMARTFLOW I ADMINISTRATION SET

FDA 510(k)

FDA Class 2 ·General Hospital

PHONERIS INNER CANNULAE WITH PHONERIS AERO-FLEX VENTILATOR CIRCUIT CONNECTOR

FDA 510(k)

FDA Class 2 ·Anesthesiology

NUQUEST NUCLEAR MEDICINE COMPUTER

FDA 510(k)

FDA Class 2 ·Radiology

SOLOGUARD LOCKING PLUS SYRINGE

FDA 510(k)

FDA Class 2 ·General Hospital

PRO-GUIDE

FDA 510(k)

FDA Class 2 ·Cardiovascular

RAICHEM(TM) CREATINE KINASE-MB REAGENT

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

VESSEL DILATOR

FDA 510(k)

FDA Class 2 ·Cardiovascular

NEOMED ORAL/ENTERAL SYRINGE

FDA 510(k)

FDA Class 2 ·General Hospital

DISPOSABLE COURNAND, SELDINGER & ONE-WALL NEEDLES

FDA 510(k)

FDA Class 2 ·Cardiovascular

SPECTRANETICS LEAD LOCKING DEVICE (LLD) #1, #2, #3 LISTER

FDA 510(k)

FDA Class 2 ·Cardiovascular

POSI-STOP/POSI-TRAC SYSTEM

FDA 510(k)

FDA Class 2 ·Dental

SPLASH SHIELD # 4505, 4507, PARASHIELD # 4509

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

DATASCOPE PTCA PERCUTANEOUS CATHETER INTRODUCER

FDA 510(k)

FDA Class 2 ·Cardiovascular

OSCULAR SCIENCES/ AMERICAN HYDRON, INC DAILY WEAR SOFT CONTACT LENS

FDA 510(k)

FDA Class 2 ·Ophthalmic