The Multimodality Advanced Vessel Analysis

FDA 510(k)

FDA Class 2 ·Radiology

KODEX EPD System

FDA 510(k)

FDA Class 2 ·Cardiovascular

PURITAN-BENNETT RENAISSANCE SPIROMETRY SYSTEMWITH THE OPTIONALRENAISSANCE DB DATA MANAGEMENTSOFTWARE

FDA 510(k)

FDA Class 2 ·Anesthesiology

VITROS BRAHMS PCT Reagent Pack and Calibrators

FDA 510(k)

FDA Class 2 ·Microbiology

B.R.A.H.M.S PCT sensitive KRYPTOR

FDA 510(k)

FDA Class 2 ·Microbiology

VIDAS B.R.A.H.M.S. PCT (PCT)

FDA 510(k)

FDA Class 2 ·Microbiology

Atellica IM BRAHMS Procalcitonin (PCT)

FDA 510(k)

FDA Class 2 ·Microbiology

Elecys BRAHMS PCT, Elecys BRAHMS PCT CalCheck 5

FDA 510(k)

FDA Class 2 ·Microbiology

PAXGENE BLOOD RNA SYSTEM

FDA 510(k)

FDA Class 2 ·Immunology

MODIFICATION TO PAXGENE BLOOD RNA SYSTEM

FDA 510(k)

FDA Class 2 ·Immunology

IPG, integrated, 25/40 cm, single, tined, IPG, 2 cm, single 4, Lead (25/40 cm, 4, tined), Extension - 4

FDA 510(k)

FDA Class 2 ·Neurology

SYNTHETIC SEEDING SPACER MODEL SS9 X 50-50, SS9 X 55-50, SS9 X 55-150, SS9 X 1CM-30

FDA 510(k)

FDA Class 2 ·Radiology

Straumann BLX Ø3.5 mm Implants

FDA 510(k)

FDA Class 2 ·Dental

Lung Nodule Assessment and Comparison Option (LNA)

FDA 510(k)

FDA Class 2 ·Radiology

Wheelchair, Stair Climbing

FDA Pre-Market Approval

FDA Class 2 ·INDEPENDENCE (TM) IBOT 3000/4000 MOBILITY SYSTEM

Bone Cement

FDA Pre-Market Approval

FDA Class 2 ·NORIAN SRS CEMENT

Wheelchair, Stair Climbing

FDA Pre-Market Approval

FDA Class 2 ·ACCESS MOBILITY SYSTEM

Bone Cement

FDA Pre-Market Approval

FDA Class 2 ·NORIAN SRS CEMENT

Wheelchair, Stair Climbing

FDA Pre-Market Approval

FDA Class 2 ·INDEPENDENCE IBOT 3000 MOBILITY SYSTEM

Bone Cement

FDA Pre-Market Approval

FDA Class 2 ·NORIAN SRS BONE CEMENT