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

NEOGRAM AMINO ACIDS AND ACYLCARNITINES TANDEM MASS SPECTROMETRY KIT, MODEL MS-8970

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

APTIMA TRICHOMONAS VAGINALIS ASSAY

FDA 510(k)

FDA Class 2 ·Immunology

HAMILTON THORNE ZONA INFRARED LASER OPTICAL SYSTEM (ZILOS TK)

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

VERIFY CRONOS SELF-CONTAINED BIOLOGICAL INDICATOR

FDA 510(k)

FDA Class 2 ·General Hospital

ALLOMAP MOLECULAR EXPRESSION TESTING

FDA 510(k)

FDA Class 2 ·Cardiovascular

QUIDEL MOLECULAR DIRECT HSV 1 +2/VZV ASSAY

FDA 510(k)

FDA Class 2 ·Microbiology

EUROIMMUN ANTI-PLA2R IFA

FDA 510(k)

FDA Class 2 ·Microbiology

FACTOR V LEIDEN KIT

FDA 510(k)

FDA Class 2 ·Hematology

Tornier Pyrocarbon Humeral Head

FDA 510(k)

FDA Class 2 ·Orthopedic

PROSTATE MECHANICAL IMAGER

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

Natural Cycles

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology