BHR BIPOLAR FEMORAL HEAD COMPONENT

FDA 510(k)

FDA Class 2 ·Orthopedic

GAMBRO POLYFLUX 11S, 14S, 17S & 21S HEMODIALYZERS/ HEMOFILTERS

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

PRISMA CFM (CONTINUOUS FLUID MANAGEMENT SYSTEM)

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

COBE CENTRYSYSTEM 145E,160E,175E,190E DIALYZERS

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

PROFILE MAMMOGRAPHY SYSTEM (M-PRO)

FDA 510(k)

FDA Class 2 ·Radiology

CENTRY 2 ULTRAFILTRATION CONTROL KIT, #018762-002

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

GENERAL AND PLASTIC SURGERY

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

COBE HEART/LUNG PERFUSION AND CARDIOPLEGIA PACK

FDA 510(k)

FDA Class 2 ·Cardiovascular

TOTAL OSSICULAR REPLACEMENT PROSTHESIS (TORP)

FDA 510(k)

FDA Class 2 ·Ear, Nose, Throat

Artix Ballon Guiding Sheath

FDA 510(k)

FDA Class 2 ·Cardiovascular

COBE CENTRYSYSTEM 3 BICART OPTION KIT

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

UFC HIP STEM COMPONENT

FDA 510(k)

FDA Class 2 ·Orthopedic

CEFACLOR ANTIMICROBIAL SUSCEPTIBILITY TEST DISC

FDA 510(k)

FDA Class 2 ·Microbiology

GAMBRO LUNDIA 94-600 DIALYZER

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

COBE REN NEW-D DISPENSING KIT

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

EXSPIRON

FDA 510(k)

FDA Class 2 ·Anesthesiology

EASYRA SODIUM ASSAY, EASYRA POTASSIUM ASSAY, EASYRA CHLORIDE ASSAY, EASYRA CARBON DIOXIDE ASSAY MODEL CAT NO. 5423 & 520

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

ARTHRO-TRAC(TM)

FDA 510(k)

FDA Class 2 ·Orthopedic

Dynax clear, Dynax putty, Dynax heavy body, Dynax light, Dynax mono

FDA 510(k)

FDA Class 2 ·Dental

CNS-EP SYSTEM AND EP 1.0 SOFTWARE

FDA 510(k)

FDA Class 2 ·Neurology