CARDIOSCOPE

FDA 510(k)

FDA Class 2 ·Cardiovascular

LULLABY LED PHOTTHERAPY SYSTEM

FDA 510(k)

FDA Class 2 ·General Hospital

VIGILANT EEG MONITOR, VIGILANT 2.0

FDA 510(k)

FDA Class 2 ·Neurology

HEARTRAIL III GUIDING CATHETER

FDA 510(k)

FDA Class 2 ·Cardiovascular

Flex Robotic System and Flex Colorectal Drive

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

MODIFICATION TO RAICHEM CALCIUM REAGENT

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

IMMUNOMATRIX THEOPHYLINE ASSAY SYSTEM

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

CPU GRAPH

FDA 510(k)

FDA Class 2 ·Anesthesiology

TOTAL CONDYLAT TYPE KNEE SYSTEM

FDA 510(k)

FDA Class 2 ·Orthopedic

LIFELINES TRACKIT

FDA 510(k)

FDA Class 2 ·Neurology

CAPIOX FLEXIBLE VENOUS RESERVOIR

FDA 510(k)

FDA Class 2 ·Cardiovascular

BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM - VANCOMYCIN (0.5-32 UG/ML)

FDA 510(k)

FDA Class 2 ·Microbiology

AMBU SILICONE RESUSCITATOR INFAN/CHILD W/OPEN RESO

FDA 510(k)

FDA Class 2 ·Anesthesiology

Oncospace

FDA 510(k)

FDA Class 2 ·Radiology

OVUS CAPLESS SAFETY NEEDLE

FDA 510(k)

FDA Class 2 ·General Hospital

Clear Guide SCENERGY

FDA 510(k)

FDA Class 2 ·Radiology

CAMLOG ROOTFORM IMPLANT SYSTEM

FDA 510(k)

FDA Class 2 ·Dental

GORE-TEX DUALMESH PLUS BIOMATERIAL

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

HIGH FLUX HEMODIALYSIS MEMBRANE DIALYZER OR HIGH FLUX HOLLOW FIBER DIALYZER, MODELS APS-R, -M, -S, -E, AND -EX

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM - CEFOXITIN - 0.5-64 UG/ML

FDA 510(k)

FDA Class 2 ·Microbiology