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

STRATIFY JCV(TM) ANTIBODY

FDA 510(k)

FDA Class 2 ·Microbiology

MagDI System

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

RIDASCREEN NOROVIRUS 3RD GENERATION EIA

FDA 510(k)

FDA Class 2 ·Microbiology

MAMMAPRINT

FDA 510(k)

FDA Class 2 ·Immunology

Vitamin D 200M Assay for the Topaz System

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

BIO-SEAL LUNG BIOPSY TRACT SYSTEM

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

TINA-QUANT HBA1C GEN. 2 TEST SYSTEM

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

UROSURGE PERCUTANEOUS SANS (STOLLER AFFERENT NERVE STIMULATOR) DEVICE

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

LBA AFP-L3, AFP-L3 CALIBRATOR SET, AFP-L3 CONTROL SET AND LIBASYS

FDA 510(k)

FDA Class 2 ·Immunology

VIRULITE COLD SORE MACHINE

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

VYSIS EGR1 FISH PROBE KIT - SC (SPECIMEN CHARACTERIZATION)

FDA 510(k)

FDA Class 2 ·Hematology

KAVO DIAGNODENT

FDA 510(k)

FDA Class 2 ·Dental

INFRASCANNER, MODEL 1000

FDA 510(k)

FDA Class 2 ·Ophthalmic

HEALTHCHECK(TM) HOME TEST FOR LOSS OF THE SENSE OF SMELL

FDA 510(k)

FDA Class 2 ·Ear, Nose, Throat