NOVA MAX PLUS BLOOD GLUCOSE AND B-KETONE MONITOR SYSTEM, NOVA MAX PLUS B-KETONE CONTROL SOLUTIONS, NOVA MAX BLOOD GLUCOS

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

Vitrea Software Package, VSTP-001A

FDA 510(k)

FDA Class 2 ·Radiology

SERIES V-SCAN RADIOGRAPHIC FILM SCANNER

FDA 510(k)

FDA Class 2 ·Radiology

Aquilion ONE (TSX-305A/6) V8.9 with AiCE

FDA 510(k)

FDA Class 2 ·Radiology

Aquilion Prime SP (TSX-303B8) V10.2 with AiCE-i

FDA 510(k)

FDA Class 2 ·Radiology

ONCENTRA PROSTATE 4.0

FDA 510(k)

FDA Class 2 ·Radiology

RESIN 11

FDA 510(k)

FDA Class 2 ·Anesthesiology

EG-3670URK

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

ACUTRON MENTOR MODEL 961

FDA 510(k)

FDA Class 2 ·Neurology

Li-Battery powered OTC TENS/EMS, model EV-804, model EV-805, & model EV-806

FDA 510(k)

FDA Class 2 ·Neurology

COAT-A-COUNT BARBITURATES TKBA1 AND TKBA5

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

MODIFICATION TO: HL168W TOUCH SCREEN

FDA 510(k)

FDA Class 2 ·Cardiovascular

Parcus Twist AP Suture Anchors

FDA 510(k)

FDA Class 2 ·Orthopedic

AUTO-PEEP

FDA 510(k)

FDA Class 2 ·Anesthesiology

LASERSCOPE GUIDED DELIVERY DEVICE (GDD) CYSTOURETHROSCOPE & ACCESSORIES

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

NOVAPACS, NOVAVIEW, NOVACARDIO, NOVAQC AND NOVAER

FDA 510(k)

FDA Class 2 ·Radiology

ESPRIT VENTILATOR

FDA 510(k)

FDA Class 2 ·Anesthesiology

FC-38TLH, FIBER COLONOSCOPE

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

SYNCHRON SYSTEMS VALPROIC ACID (VPA) REAGENT

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

CLEARFIL FII NEW BOND

FDA 510(k)

FDA Class 2 ·Dental