NAV PAK Needle, NIM NAV PAK Needle

FDA 510(k)

FDA Class 2 ·Ear, Nose, Throat

HawkOne Directional Atherectomy System

FDA 510(k)

FDA Class 2 ·Cardiovascular

Vivid E80, Vivid E90, Vivid E95

FDA 510(k)

FDA Class 2 ·Radiology

Venue Fit

FDA 510(k)

FDA Class 2 ·Radiology

Venue

FDA 510(k)

FDA Class 2 ·Radiology

LASER SYSTEM YELLOWSTAR

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

NOVA CO-OXIMETER ANALYZER

FDA 510(k)

FDA Class 2 ·Hematology

NOVA 16 ANALYZER (MODIFICATION POINT OF CARE USAGE)

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

STAT PROFILE ULTRA 11 ANALYZER (MODIFICATION)

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

STAT PROFILE PHOX ANALYZER

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

STAT PROFILE PHOX CO-OXIMETER ANALYZER, NOVA CO-OXIMETER CONTROLS, LEVELS 1 AND 2, NOVA CO-OXIMETER THB CALIBRATOR

FDA 510(k)

FDA Class 2 ·Hematology

Enzyme Immunoassay, Tracrolimus

FDA Pre-Market Approval

FDA Class 2 ·IMX TACROLIMUS II

Enzyme Immunoassay, Tracrolimus

FDA Pre-Market Approval

FDA Class 2 ·IMX TACROLIMUS II ASSAY

Enzyme Immunoassay, Tracrolimus

FDA Pre-Market Approval

FDA Class 2 ·PRO-TRAC II TACROLIMUS ELISA KIT

Enzyme Immunoassay, Tracrolimus

FDA Pre-Market Approval

FDA Class 2 ·IMX TACROLIMUS II

Enzyme Immunoassay, Tracrolimus

FDA Pre-Market Approval

FDA Class 2 ·ABBOTT IMX TACROLIMUS II

Enzyme Immunoassay, Tracrolimus

FDA Pre-Market Approval

FDA Class 2 ·IMX TACROLIMUS II

Integrity V500 (Integrity, Integrity with VEMP)

FDA 510(k)

FDA Class 2 ·Neurology

VIVOSONIC NEUROSCREEN

FDA 510(k)

FDA Class 2 ·Neurology

SAM CRRT Unit, SAM Cassette CRRT

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology