SEKI AOI TECHNO.CO.,LTD

FDA registration

SEKI AOI TECHNO.CO.,LTD·1 product·🇯🇵 Japan

Coronary Drug-Eluting Stent

FDA Pre-Market Approval

FDA Class 3 ·SYNERGY XD Everolimus Eluting Platinum Chromium Coronary Stent System and SYNERGY SHIELD Everolimus Eluting Platinum Chr

PowerCHO-2 CD, w/o L-Gln w/o PR or HT,1L

FDA UDI

Lonza Verviers·05407010120493·

PowerCHO-2 CD, w/o L-Gln w/o PR or HT,1L

FDA UDI

Lonza Verviers·05407010122701·

SHANGHAI CHINA STAR CORP POWDERED BLUE NITRILE PATIENT EXAMINATION GLOVES

FDA 510(k)

FDA Class 1 ·General Hospital

SHANGHAI CHINASTAR POWER-FREE BLUE NITRIL EXAMINATION GLOVES

FDA 510(k)

FDA Class 1 ·General Hospital

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