COAGUCHEK PRO SYSTEM, APTT TEST CARTRIDGES FOR COAGUCHEK PRO SYSTEM, APTT CONTROLS FOR COAGUCHEK PRO SYSTEM, COAGUCHEK P

FDA 510(k)

FDA Class 2 ·Hematology

ENZYMATIC CO2 REAGENT SET

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

ROCHE DIAGNOSTICS, BOEHRINGER MANNHEIM CORPORATION LIQUID DIRECT BILIRUBIN REAGENT, CATALOG NUMBER 1877844

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

ETHANOL CALIBRATOR

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

DURAZYME(R) CPK

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

ACCU-CHEK COMPACT SYSTEM, ACCU-CHEK COMPACT TEST STRIPS, ACCU-CHEK COMPACT COMPACT CONTROLS

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

KINETIC 610 ETHANOL

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

NEUROMED MODEL OCA-30 OCTODE AND MODEL SCA-30

FDA 510(k)

FDA Class 2 ·Neurology

ASAHI PTCA GUIDE WIRE, FIELDER FC J, MODELS: AGP140001J, AGP140301J

FDA 510(k)

FDA Class 2 ·Cardiovascular

ASSERACHROM PF4 KIT

FDA 510(k)

FDA Class 2 ·Hematology

Lenses, Soft Contact, Daily Wear

FDA Pre-Market Approval

FDA Class 2 ·OCU-FLEX-53 SOFT CONTACT LENSES

VivoSight Dx Topical OCT System

FDA 510(k)

FDA Class 2 ·Radiology

OPTIS Metallic Stent Optimization E.4 SW

FDA 510(k)

FDA Class 2 ·Radiology

OPXION Optical Skin Viewer (OPXSV1-01F)

FDA 510(k)

FDA Class 2 ·Radiology

Ilumien Optis, Optis Integrated, Optis Mobile

FDA 510(k)

FDA Class 2 ·Radiology

Starlight Imaging Catheter

FDA 510(k)

FDA Class 2 ·Radiology

OTIS Optical Coherence Tomography System

FDA 510(k)

FDA Class 2 ·Radiology

Cornaris Intravascular Imaging System (P80-E); Cornaris Intravascular Imaging System (Mobile-E); LumenCross Imaging Catheter (F2)

FDA 510(k)

FDA Class 2 ·Radiology

OPTIS Mobile System

FDA 510(k)

FDA Class 2 ·Radiology

NvisionVLE Imaging Console, NvisionVLE Marking Probe, 20mm balloon, NvisionVLE Marking Probe, 17mm balloon,NvisionVLE Marking Probe, 14mm balloon, NvisionVLE Inflation System

FDA 510(k)

FDA Class 2 ·Radiology