HOOK SURGICAL INSTRUMENT

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

AcroDTI Visualizer

FDA 510(k)

FDA Class 2 ·Radiology

DISSECTION PROBE

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

COCAINE METABOLITE ENZYME IMMUNOASSAY MODELS #0030 (500 TESTS KIT), #0031 (5000 TESTS KIT)

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

ZIRACE

FDA 510(k)

FDA Class 2 ·Dental

UBI MAGIWEL C-REACTIVE PROTEIN(CRP) QUANTITATIVE

FDA 510(k)

FDA Class 2 ·Immunology

ENDOSCOPE

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

SINGLE ANALYTE URINE DRUGS OF ABUSE CALIBRATORS AND CONTROLS

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

LAPAROSCOPIC BALLOON RETRACTOR

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

SOUNDBITE HEARING SYSTEM BY SONITUS MEDICAL

FDA 510(k)

FDA Class 2 ·Ear, Nose, Throat

MAXIMA, TRUSTEX, RIA AND PREMIUM CONDOMS

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

Sterile Disposable Syringe, Sterile Disposable Syringe with needle, Sterile Disposable Syringe with safety needle

FDA 510(k)

FDA Class 2 ·General Hospital

DIGORA

FDA 510(k)

FDA Class 2 ·Radiology

CYSTATIN C ANTISERUM, CALIBRATOR, CONTROL AND CONTROL HIGH

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

AST/GOT (IFCC), PYRIDOXAL PHOSPHATE, ECAL, NORTROL AND ABTROL

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

INION CPS BSSO SCREW

FDA 510(k)

FDA Class 2 ·Orthopedic

CARESCAPE MONITOR B650

FDA 510(k)

FDA Class 2 ·Cardiovascular

CRANEX BASEX D OR CRANEX EXCEL D

FDA 510(k)

FDA Class 2 ·Dental

PLLA PIN

FDA 510(k)

FDA Class 2 ·Orthopedic

ELEKTA OY

FDA 510(k)

FDA Class 2 ·Neurology