ACCESS EPO ASSAY

FDA 510(k)

FDA Class 2 ·Hematology

OCCLUSION BALLOON CATHETER MODEL OBC

FDA 510(k)

FDA Class 2 ·Cardiovascular

NovaGold High Performance Guidewire

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

Disposable Gold Cup EEG Electrodes

FDA 510(k)

FDA Class 2 ·Neurology

Diamondback 360 Peripheral Orbital Atherectomy System Exchangeable Series

FDA 510(k)

FDA Class 2 ·Cardiovascular

Titanium Interference Screws

FDA 510(k)

FDA Class 2 ·Orthopedic

VASCU-GUARD Peripheral Vascular Patch

FDA 510(k)

FDA Class 2 ·Cardiovascular

AQUADEX SYSTEM 100, MODEL A1100

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

3M™ VitCal Liner/Base

FDA 510(k)

FDA Class 2 ·Dental

REACH FEMORAL HIP COMPONENT

FDA 510(k)

FDA Class 2 ·Orthopedic

MYLABFIVE

FDA 510(k)

FDA Class 2 ·Radiology

SCHNEIDER MONORAIL 421 PERCU TRANS ANGIO (PTA) BAL

FDA 510(k)

FDA Class 2 ·Cardiovascular

PT2 GUIDE WIRE AND ADDWIRE EXTENSION WIRE

FDA 510(k)

FDA Class 2 ·Cardiovascular

SPOROX TEST STRIPS

FDA 510(k)

FDA Class 2 ·General Hospital

COBALT V RADIOPAQUE VERTEBROPLASTY BONE CEMENT

FDA 510(k)

FDA Class 2 ·Orthopedic

PRONTO .035 EXTRACTION CATHETER

FDA 510(k)

FDA Class 2 ·Cardiovascular

ISCALERT SENSOR SYSTEM

FDA 510(k)

FDA Class 2 ·Anesthesiology

DIAMONDBACK 360 DEGREE ORBITAL ATHERECTOMY SYSTEM

FDA 510(k)

FDA Class 2 ·Cardiovascular

DLP Aortic Root Cannula, DLP Aortic Root Cannula with Vent Line, DLP Pressure Monitoring Extension Line Adapter, DLP Cardioplegia Adapter with Pressure Port

FDA 510(k)

FDA Class 2 ·Cardiovascular

ROSTAM APPLICATOR TAMPON/ROSTAM NON APPLICATOR TAMPON

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology