KOWA KT-800

FDA 510(k)

FDA Class 2 ·Ophthalmic

DIRECT DIGITIZER, REGIUS MODEL 190

FDA 510(k)

FDA Class 2 ·Radiology

Scanning Laser Ophthalmoscope Mirante [SLO/OCT Model] with Image Filing Software NAVIS-EX; Scanning Laser Ophthalmoscope Mirante [SLO Model] with Image Filing Software NAVIS-EX

FDA 510(k)

FDA Class 2 ·Ophthalmic

DELUXE MAGMAG BREAST PUMP

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

PreXion3D Explorer PRO

FDA 510(k)

FDA Class 2 ·Radiology

ASAHI Caravel

FDA 510(k)

FDA Class 2 ·Cardiovascular

TSK STERIJEKT PREMIUM DISPOSABLE HYPODERMIC NEEDLE

FDA 510(k)

FDA Class 2 ·General Hospital

TERUMO MICRO TAPERED PEN NEEDLE

FDA 510(k)

FDA Class 2 ·General Hospital

ASAHI Peripheral Guide Wire Series (ASAHI Gladius, ASAHI Halberd, ASAHI Gaia PV)

FDA 510(k)

FDA Class 2 ·Cardiovascular

VASSALLO GT 018 Floppy

FDA 510(k)

FDA Class 2 ·Cardiovascular

TERUMO SURFLASH SAFETY I.V. CATHETER

FDA 510(k)

FDA Class 2 ·General Hospital

NanoZoomer S360MD Slide scanner system

FDA 510(k)

FDA Class 2 ·Pathology

ADVANCED MAGMAG AC/BATTERY BREAST PUMP

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

GLUCOCARD® W onyx Blood Glucose Monitoring System

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

STERiJECT Low Dead Space, STERiJECT The Invisible Needle

FDA 510(k)

FDA Class 2 ·General Hospital

ASAHI PTCA Guide Wire ASAHI SUOH 03

FDA 510(k)

FDA Class 2 ·Cardiovascular

ASAHI Fielder XT-A, ASAHI Fielder XT-R

FDA 510(k)

FDA Class 2 ·Cardiovascular

CRP-LATEX SEIKEN XR REAGENT SYSTEM

FDA 510(k)

FDA Class 2 ·Immunology

NIDEK GREEN LASER PHOTOCOAGULTOR MODEL GYC-1000 CONNECTED WITH THE ENDOPHOTOCOAGULATION DELIVERY UNIT

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

Zimed Distal Medial Tibial Plate and Screw System

FDA 510(k)

FDA Class 2 ·Orthopedic