EBV/EA-CHECK TM TEST KIT

FDA 510(k)

FDA Class 1 ·Microbiology

MODEL 5135 AUTO LP/FLASH

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

COMPANION 318 NASAL CPAP DIAGNOSTICS SYSTEM

FDA 510(k)

FDA Class 2 ·Anesthesiology

FLEXIBLE FIBERSCOPE, MODEL 7331.001, GUIDE SECTION FOR LITHOVAC HANDPIECE, MODEL 8708.253

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

HEPARIN ASSAY CARTRIDGES AND CONTROLS

FDA 510(k)

FDA Class 2 ·Hematology

NOBEL DIRECT, MODELS 30937, 30938

FDA 510(k)

FDA Class 2 ·Dental

REPLACE SCALLOPED MARGIN IMPLANT SYSTEM

FDA 510(k)

FDA Class 2 ·Dental

VITOSS BIOACTIVE FOAM PACK BONE GRAFT SUBSTITUTE

FDA 510(k)

FDA Class 2 ·Orthopedic

SPLITTABLE SHEATH INTRODUCER KIT

FDA 510(k)

FDA Class 2 ·Cardiovascular

JO Coconut Hybrid Cooling Personal Lubricant

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

MONARCH COMPAK INFLATION SYRINGE AND UNIVERSAL FLUID DISPENSING SYRINGE

FDA 510(k)

FDA Class 2 ·Cardiovascular

FOCUS DAILIES PROGRESSIVES

FDA 510(k)

FDA Class 2 ·Ophthalmic

EDWARDS LIFESCIENCES INTRACLUDE INTRA-AORTIC CATHETER

FDA 510(k)

FDA Class 2 ·Cardiovascular

VITAL STATISTICS SYSTEM (O-CATH ACCESSORY)

FDA 510(k)

FDA Class 2 ·Cardiovascular

MEDICAL GRADE SILICONE BLOCK

FDA 510(k)

FDA Class 2 ·Ear, Nose, Throat

MODIFICATION TO ALARMVIEW WIRELESS DATA NETWORK SYSTEM

FDA 510(k)

FDA Class 2 ·Cardiovascular

MODIFICATION TO YASARGIL ANEURYSM CLIPS

FDA 510(k)

FDA Class 2 ·Neurology

ELECTROMEDICS EL-SERIES CARDIOTOMY RESERVOIR

FDA 510(k)

FDA Class 2 ·Cardiovascular

OTT CERVICAL TENACULUM

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

GRASPING FORCEPS, BIOPSY FORCEPS, SCISSORS, PUNCH

FDA 510(k)

FDA Class 2 ·Orthopedic