FILTRAL TM 8 HEMODIALYZER

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

Oravan Herbst

FDA 510(k)

FDA Class 2 ·Dental

GENERAL DIAG. CHROMOSTRATE HEPARIN ASSAY

FDA 510(k)

FDA Class 2 ·Hematology

SYREX HEPARIN LOCK FLUSH SYRINGE, 1 UNIT/ML & 2 UNITS/ML

FDA 510(k)

FDA Class 2 ·General Hospital

QWIX POSITIONING SCREW

FDA 510(k)

FDA Class 2 ·Orthopedic

LIGHT CURE FILLING MATERIAL

FDA 510(k)

FDA Class 2 ·Dental

b-ONE MOBIO Total Knee System

FDA 510(k)

FDA Class 2 ·Orthopedic

AVS A-LAT PEEK SPACERS, MODELS 48750XXX, 48751XXX, 48752XXX, 48753XXX

FDA 510(k)

FDA Class 2 ·Orthopedic

AUXILIARY PATIENT TABLE/MAGNETOM OPEN SYSTEM

FDA 510(k)

FDA Class 2 ·Radiology

ACCOLADE-J HIP STEM SERIES

FDA 510(k)

FDA Class 2 ·Orthopedic

BECTON DICKINSON SYRINGE

FDA 510(k)

FDA Class 2 ·General Hospital

AIR-BAND RADIAL COMPRESSION DEVICE

FDA 510(k)

FDA Class 2 ·Cardiovascular

HOWMEDICA BIPOLAR PROSTHESIS

FDA 510(k)

FDA Class 2 ·Orthopedic

IONOCAL

FDA 510(k)

FDA Class 2 ·Dental

BD FlowSmart Set, MiniMed Pro-Set

FDA 510(k)

FDA Class 2 ·General Hospital

ALEVE Direct Therapy (ALEVE Direct Therapy TENS Device)

FDA 510(k)

FDA Class 2 ·Neurology

THROMBO-CALIBRATOR KIT

FDA 510(k)

FDA Class 2 ·Hematology

EPCOR

FDA 510(k)

FDA Class 2 ·Cardiovascular

b-ONE® Total Hip System

FDA 510(k)

FDA Class 2 ·Orthopedic

SYSTEMATE(TM) DIRECT BILIRUBIN CATALOG NO. 65406

FDA 510(k)

FDA Class 2 ·Clinical Chemistry