COMPAS

FDA 510(k)

FDA Class 2 ·Anesthesiology

DOME CX DIGITAL FLAT-PANEL DISPLAY SYSTEM, MODELS C2 AND C5I

FDA 510(k)

FDA Class 2 ·Radiology

STAR ST AND ARRHYTHMIA SOFTWARE, RELEASE H.0

FDA 510(k)

FDA Class 2 ·Cardiovascular

MULTIPURPOSE, NEPHROSTOMY AND BILIARY DRAINAGE CATHETERS

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

MICRO ENDOSCOPIC ELECTRODE (ME2)

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

OPTIFLUX ULTRA DIALYZER

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

TAP Blood Collection Device

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

PALLINDROME 14.5FR CHRONIC HEMODIALYSIS CATHETER

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

O.M.S. GUILLOTINE CUTTER

FDA 510(k)

FDA Class 2 ·Ophthalmic

SNAP-PAK (TM)

FDA 510(k)

FDA Class 2 ·Orthopedic

EXPEDIUM SPINE SYSTEM

FDA 510(k)

FDA Class 2 ·Orthopedic

SmartByte Device

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

ALEXANDER MANUFACTURING CO. RECHARGEABLE BATTERY PART NUMBER MS5169

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

REUSABLE TEMPERATURE PROBES (M1024254 SKIN TEMPERATURE PROBE, REUSABLE; M1024247, GP TEMPERATURE PROBE, ADULT, RESUABLE

FDA 510(k)

FDA Class 2 ·General Hospital

SUPERPETT

FDA 510(k)

FDA Class 2 ·Radiology

NXSTAGE CONNECTED HEALTH SYSTEM

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

MONOGRAM I

FDA 510(k)

FDA Class 2 ·Dental

GYRUS ACMI BICOAG HEMOSTASIS PROBE

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

MODIFIED TRANSLUMINAL BALLOON DILATATION CATHETERS

FDA 510(k)

FDA Class 2 ·Cardiovascular

VitroPRO

FDA 510(k)

FDA Class 2 ·Radiology