NIOX ARTICLE NO: 02-1000

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

LIPFLOW THERMAL PULSATION SYSTEM (FORMERLY MANUAL MINI SYSTEM)

FDA 510(k)

FDA Class 2 ·Ophthalmic

WALLAC NEONATAL BIOTINIDASE TEST KIT, MODELS NB-1000; NB-4000

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

TRIAGE B-TYPE NATRIURETIC PEPTIDE (BNP) TEST

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

VERIGENE GRAM POSITIVE BLOOD CULTURE NUCLEIC ACID TEST (BC-GP)

FDA 510(k)

FDA Class 2 ·Microbiology

ENDOTOXIN ACTIVITY ASSAY (EAA) DEVICE

FDA 510(k)

FDA Class 2 ·Microbiology

PAXGENE BLOOD RNA SYSTEM

FDA 510(k)

FDA Class 2 ·Immunology

DULBECCO'S MODIFIED EAGLE MEDIUM (DMEM)

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

BREASTVIEW VISUAL MAPPING SYSTEM

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

CABOCHON SYSTEM

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

OVA1 TEST

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

PRINEO SKIN CLOSURE SYSTEM

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

PROTEUS INGESTION CONFINMATION SYSTEMS

FDA 510(k)

FDA Class 2 ·General Hospital

SNAP WOUND CARE DEVICE

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

ULTHERA SYSTEM, MODEL 8850-0001

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

CEDIA SIROLIMUS ASSAY

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

MOERAE SURGICAL MARKING PEN

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

Medtronic DUET External Drainage and Monitoring System

FDA 510(k)

FDA Class 2 ·Neurology

GIVEN DIAGNOSTIC IMAGING SYSTEM

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

WIDEXLINK IN CLEAR SERIES HEARING AIDS

FDA 510(k)

FDA Class 2 ·Ear, Nose, Throat