Aquilion Precision (TSX-304A/4) V10.10 with AiCE

FDA 510(k)

FDA Class 2 ·Radiology

Assure Titanium Blood Glucose Monitoring System

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

SUPERCATH 5 MODEL SP120-XX-XX, SP125-XX-XX

FDA 510(k)

FDA Class 2 ·General Hospital

DIRECT DIGITIZER, REGIUS MODEL 190

FDA 510(k)

FDA Class 2 ·Radiology

Lucica Glycated Albumin-L

FDA 510(k)

FDA Class 2 ·Hematology

COLORPOINT OR PROFESSIONAL COLORPOINT

FDA 510(k)

FDA Class 2 ·Radiology

FUJIFILM Endoscope Model EC-760S-A/L, Endoscopy Support Program EW10-VM01

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

FILM DIGITIZER MODEL 2905

FDA 510(k)

FDA Class 2 ·Radiology

NanoZoomer S360MD Slide scanner system

FDA 510(k)

FDA Class 2 ·Pathology

VISERA S VIDEO SYSTEM CENTER OLYMPUS OTV-S500 (OLYMPUS OTV-S500)

FDA 510(k)

FDA Class 2 ·Ear, Nose, Throat

INFX-8000V with Wireless Footswitch

FDA 510(k)

FDA Class 2 ·Radiology

ASAHI Astato XS 40

FDA 510(k)

FDA Class 2 ·Cardiovascular

21,3-INCH (54CM) MONOCHROME LCD MONITOR ME213L (MDL2108A)

FDA 510(k)

FDA Class 2 ·Radiology

FDR D-EVO III flat panel detector system

FDA 510(k)

FDA Class 2 ·Radiology

PELNAC Meshed Bilayer Wound Matrix

FDA 510(k)

FDA Unclassified ·Unknown

VASSALLO GT Crossing14

FDA 510(k)

FDA Class 2 ·Cardiovascular

OMRON ULTRASONIC NEBULIZER MODEL NE-UO5

FDA 510(k)

FDA Class 2 ·Anesthesiology

Yamahachi Pink CAD/CAM Disk

FDA 510(k)

FDA Class 2 ·Dental

Menicon ASRB (asmofilcon A) Silicone Hydrogel Soft Contact Lens

FDA 510(k)

FDA Class 2 ·Ophthalmic

R2P Radifocus Glidewire Advantage

FDA 510(k)

FDA Class 2 ·Cardiovascular