HEMOCATH I KIDNEY DIALYSIS CATHETER

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

COAXIAL DUAL FLOW CATHETER

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

DUAL LUMEN NEEDLES

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

MODIFIED DUAL LUMEN NEEDLE

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

DUAL LUMEN NEEDLE (PRODUCT CHANGE)

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

SWAN-GANZE CONTINUOUS CARDIAC OUTPUT/OXIMETRY/VENOUS INFUSION PORT/EJECTION FRACTION/VOLUMETRIC (CCO/SVO2/VIP/REF) CATH]

FDA 510(k)

FDA Class 2 ·Cardiovascular

STREAK RETINOSCOPE RX-1

FDA 510(k)

FDA Class 2 ·Ophthalmic

DIGITAL RADIOGRAPHY CXDI-710C WIRELESS, DIGITAL RADIOGRAPHY CXDI-810C WIRELESS

FDA 510(k)

FDA Class 2 ·Radiology

HALOGEN OPHTHALMO-OTOSCOPE SET BX A - 134

FDA 510(k)

FDA Class 2 ·Ophthalmic

OPTICAL COHERENCE TOMOGRAPHY 3D OCT-2000

FDA 510(k)

FDA Class 2 ·Ophthalmic

IMAGEnet6 Ophthalmic Data System

FDA 510(k)

FDA Class 2 ·Radiology

RETINA CAMERA TRC-NW7SF MARK II

FDA 510(k)

FDA Class 2 ·Ophthalmic

Branchor X Balloon Guide Catheter

FDA 510(k)

FDA Class 2 ·Cardiovascular

MINAMO

FDA 510(k)

FDA Class 2 ·Cardiovascular

DIGITAL PRINTER P6000D SERIES, MODEL P6000DU

FDA 510(k)

FDA Class 2 ·Radiology

3D Optical Coherence Tomography (3D OCT-1(type: Maestro2))

FDA 510(k)

FDA Class 2 ·Ophthalmic

Sumitomo Proton Therapy System

FDA 510(k)

FDA Class 2 ·Radiology

ASAHI PTCA Guide Wire ASAHI Gladius Mongo 14, ASAHI Gladius Mongo 14 ES

FDA 510(k)

FDA Class 2 ·Cardiovascular

GLUCOCARD 01 Blood Glocose Monitoring System/ReliOn Confirm Blood Glucose Monitoring System

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

Acrylic Block

FDA 510(k)

FDA Class 2 ·Dental