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

TROCKI BODY VENTRILATOR

FDA 510(k)

FDA Class 2 ·Anesthesiology

HEMODIALYSIS CONCENTRATES AND RELATED PRODUCTS

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

Apache Ultrasound System

FDA 510(k)

FDA Class 2 ·Radiology

Catheter, Electrode Recording, Or Probe, Electrode Recording

FDA Pre-Market Approval

FDA Class 2 ·nMARQ Catheter Interference Cable

Steerable Intracardiac Catheter Introducer Kit and Transseptal Needle

FDA 510(k)

FDA Class 2 ·Cardiovascular

Medical Surgical Mask (Non-sterile)

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

ASSERACHROM PF4 KIT

FDA 510(k)

FDA Class 2 ·Hematology

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