AXSYM REA ETHANOL

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

NEWFIX SCREW, WIRE AND PIN FIXARION SYSTEM

FDA 510(k)

FDA Class 2 ·Orthopedic

OMEGA LABORATORIES HAIR DRUG SCREENING ASSAY FOR OPIATES

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

JETPREP FLUSHING DEVICE OL-103037, JETPREP FLUSHING DEVICE OL-133037, JETPREP FLUSHING DEVICE OL-168037, JETPREP FLUSHIN

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

NARKOMED MRI , NM-MRI

FDA 510(k)

FDA Class 2 ·Anesthesiology

ISSYS DRUG FLOW MONITOR

FDA 510(k)

FDA Class 2 ·General Hospital

NORIAN DRILLABLE INJECT, NORIAN DRILLABLE FAST SET PUTTY

FDA 510(k)

FDA Class 2 ·Orthopedic

OMEGA LABORATORIES HAIR DRUG SCREENING ASSAY FOR COCAINE AND COCAINE METABOLITES

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

Rezum System

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

FLAME PHOTOMETER STANDARD

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

ST'RIM

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

BIOACTIVE BONE GRAFT PUTTY

FDA 510(k)

FDA Class 2 ·Orthopedic

RADIANCE 330 PROTON THERAPY SYSTEM

FDA 510(k)

FDA Class 2 ·Radiology

ONCO TRAC MODEL 1, 2, 4

FDA 510(k)

FDA Class 2 ·Radiology

INQU PASTE MIX PLUS

FDA 510(k)

FDA Class 2 ·Orthopedic

SIM

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

TACTIPEN

FDA 510(k)

FDA Class 2 ·General Hospital

OKAMOTO STUDDED CONDOM

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

MICROVISION SCLERAL BUCKLING COMPONENTS

FDA 510(k)

FDA Class 2 ·Ophthalmic

SPECTRUM V.0

FDA 510(k)

FDA Class 2 ·Radiology