NEOBLUE COZY LED PHOTOTHERAPY SYSTEM

FDA 510(k)

FDA Class 2 ·General Hospital

ICE Aspiration System

FDA 510(k)

FDA Class 2 ·Cardiovascular

IN VISION GOLD WITH SPIN VISION, MODEL 891 SV

FDA 510(k)

FDA Class 2 ·Radiology

CALDERA MESH

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

EAGLE EYE GOLD IVUS IMAGING CATHETER, MODEL 85900, AVABAR F/X IVUS IMAGING CATHETER, MODEL 85700

FDA 510(k)

FDA Class 2 ·Cardiovascular

ISOTRAK AMYLASE TEST AMYLASE ISOENZYME

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

OCTOSTIM

FDA 510(k)

FDA Class 2 ·Physical Medicine

NIDEK MODELS AC-2100 & 2200

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

TARGET THERAPEUTICS COILS

FDA 510(k)

FDA Class 2 ·Cardiovascular

ARGEDENT 77PF

FDA 510(k)

FDA Class 2 ·Dental

NIDEK MODEL VT-4000, MODIFICATION

FDA 510(k)

FDA Class 2 ·Ophthalmic

RADIANT MEDICAL ENDOCATHETER TEMPERATURE PROBE

FDA 510(k)

FDA Class 2 ·Cardiovascular

ACUSON V714 TRANSDUCER

FDA 510(k)

FDA Class 2 ·Radiology

CEDARS-SINAI QUANTITATIVE THALLIUM-201 ANALYSIS

FDA 510(k)

FDA Class 2 ·Radiology

MODIFICATION TO: HYDROCOIL EMBOLIC SYSTEM (HES)

FDA 510(k)

FDA Class 2 ·Neurology

STABILIZER SOFT TISSUE ANCHOR, 8MM MODEL TA1008, ANCHOR INSERTER/SUTURE ORGANIZER, 8MM MODEL AI1008, STABILIZER DRILL, 8

FDA 510(k)

FDA Class 2 ·Orthopedic

Daytona® Small Stature Spinal System

FDA 510(k)

FDA Class 2 ·Orthopedic

EXCELART WITH PIANISSIMO, MODEL MRT-1501/P3

FDA 510(k)

FDA Class 2 ·Radiology

ARTHROCARE WANDS

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

SYNTHES (USA) ARTICULATING DISTAL RADIUS (ADRF) SYSTEM

FDA 510(k)

FDA Class 2 ·Orthopedic