Aplio i900/i800/i700/i600 Diagnostic Ultrasound System, Aplio a550, Aplio a450, and Aplio a, Diagnostic Ultrasound System, Xario200G and Xario100G, Diagnostic Ultrasound System

FDA 510(k)

FDA Class 2 ·Radiology

T-TAS 01 Total Thrombus-formation Analysis System Instrument, PL Chip for T-TAS 01, PL Chip Reservoir Set for T-TAS 01, BAPA tube for T-TAS 01

FDA 510(k)

FDA Class 2 ·Hematology

PreXion3D Explorer PRO

FDA 510(k)

FDA Class 2 ·Radiology

Aspire Cristalle

FDA 510(k)

FDA Class 2 ·Radiology

CLEARFIL SE BOND 2 KIT; CLEARFIL SE BOND 2 VALUE PACK; CLEARFIL SE BOND 2 TRIAL PACK; CLEARFIL SE BOND 2 BOND; CLEARFIL

FDA 510(k)

FDA Class 2 ·Dental

Vantage Galan 3T, MRT-3020, V10.0 with AiCE Reconstruction Processing Unit for MR

FDA 510(k)

FDA Class 2 ·Radiology

NEOVEIL

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

GE OEC ALTITUDE

FDA 510(k)

FDA Class 2 ·Radiology

FUJIFILM Double Balloon Endoscope EI580BT

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

AS-10, CXDI-401RF

FDA 510(k)

FDA Class 2 ·Radiology

20.1 inch (51cm) Monochrome LCD Monitor ME205 (ML20205)

FDA 510(k)

FDA Class 2 ·Radiology

Disposable Biopsy Forceps (FB-211D); Disposable Biopsy Forceps (FB-221D); Disposable Biopsy Forceps (FB-231D); Disposable Biopsy Forceps (FB-241D)

FDA 510(k)

FDA Class 2 ·Ear, Nose, Throat

GLUCOCARD W Blood Glucose Monitoring System

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

KOWA VK-2s

FDA 510(k)

FDA Class 2 ·Radiology

FUJIFILM Duodenoscope Model ED-580XT

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

Radifocus Glidewire Advantage Track

FDA 510(k)

FDA Class 2 ·Cardiovascular

Progreat

FDA 510(k)

FDA Class 2 ·Cardiovascular

TDK ECG ELECTRODE MEL-08-09 & -11

FDA 510(k)

FDA Class 2 ·Cardiovascular

Visera Elite II Video System Center, Visera Elite II HD 3CMOS Autoclavable Camera Head, Visera Elite II 3CMOS Camera Head

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

TERUMO DIGITAL BLOOD PRESSURE MONITOR ES-H55A

FDA 510(k)

FDA Class 2 ·Cardiovascular