FilmArray 2.0 System

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

ZYNO MEDICAL ADMINISTRATION SET

FDA 510(k)

FDA Class 2 ·General Hospital

IFA TEST FOR ANTIBODIES TO BORRELIA BURGDORFERI

FDA 510(k)

FDA Class 2 ·Microbiology

CARRICELL

FDA 510(k)

FDA Class 2 ·Orthopedic

ACKRAD MPR DRAINAGE CATHETER SET

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

Natural Cycles

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

MODIFIED HYSTEROSALPINGOGRAPY SET

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

MODEL 100 VISUAL EVOKED RESPONSE RECORDING SYSTEM

FDA 510(k)

FDA Class 2 ·Neurology

COBE CML3

FDA 510(k)

FDA Class 2 ·Cardiovascular

DIACARE MONITORING SYSTEM

FDA 510(k)

FDA Class 2 ·Anesthesiology

RODENSTOCK SCANNING LASER OPHTHALMOSCOPE

FDA 510(k)

FDA Class 2 ·Ophthalmic

SPECIFIC ALLERGEN MODULES FOR ALASTAT(TM) IGE SYS.

FDA 510(k)

FDA Class 2 ·Immunology

ULTRAPAC II SD (TM)

FDA 510(k)

FDA Class 2 ·Neurology

MODIFIED DDI SEROCARD TOXOPLASMA IGG TEST KIT

FDA 510(k)

FDA Class 2 ·Microbiology

GAMBRO ALWALL GFE 11 & 15 HOLLOW FIBER DIALYZERS

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

GAMBRO-ENGSTROM ERICA IV RESPIRATOR

FDA 510(k)

FDA Class 2 ·Anesthesiology

NOVOSTE VESSEL DILATER

FDA 510(k)

FDA Class 2 ·Cardiovascular

Non-variola Orthopoxvirus Real-time PCR Primer and Probe Set

FDA 510(k)

FDA Class 2 ·Microbiology

TANDEM(R) ICON(R) QSR(TM) HCG IMMUNO. ASSAY KIT

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

CHEM 1 CLINICAL ANALYZER (METHOD URINE CREATININE)

FDA 510(k)

FDA Class 2 ·Clinical Chemistry