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

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

SURFUSE II GEL, SURFUSE II PUTTY, EXFUSE II GEL, EXFUSE II PUTTY

FDA 510(k)

FDA Class 2 ·Dental

SMILEBOND SYSTEM

FDA 510(k)

FDA Class 2 ·Dental

MRI MARKER

FDA 510(k)

FDA Class 2 ·Radiology

K100 NEUTRAL DISPLACEMENT NEEDLE FREE CONNECTOR

FDA 510(k)

FDA Class 2 ·General Hospital

Nitrosalicylate Reduction, Amylase

FDA classification

FDA Class 2 ·Nitrosalicylate Reduction, Amylase

Enzyme Immunoassay, Primidone

FDA classification

FDA Class 2 ·Enzyme Immunoassay, Primidone

Scissors For Cytoscope, Exempt

FDA classification

FDA Class 2 ·Scissors For Cytoscope, Exempt