Single Use Aspiration Needle

FDA 510(k)

FDA Class 2 ·Ear, Nose, Throat

Digital Radiography CXDI-Pro, Digital Radiography D1

FDA 510(k)

FDA Class 2 ·Radiology

KOWA NONMYD ALPHA-DIII

FDA 510(k)

FDA Class 2 ·Ophthalmic

EVIS EUS ENDOSCOPIC ULTRASOUND CENTER OLYMPUS EU-ME2/EVIS EUS ENDOSCOPIC ULTRASOUND CENTER OLYMPUS EU-ME2 PREMIER PLUS

FDA 510(k)

FDA Class 2 ·Radiology

OneTouch Delica Safety, HemoCue Safety Lancet, Assure Lance and Assure Lance Plus, Capiject Safety Lancet, Heel Lancet Newborn, Heel Lancet Preemie

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

Aquilion ONE (TSX-306A/3) V10.0 with Spectral Imaging System

FDA 510(k)

FDA Class 2 ·Radiology

Single Use Injector

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

Aplio i900/i800/i700 Diagnostic Ultrasound System, Software V5.1

FDA 510(k)

FDA Class 2 ·Radiology

Endoscope Model EI-740D/S

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

SKR 4000

FDA 510(k)

FDA Class 2 ·Radiology

COLOR LCD MONITOR, MODEL RADIFORCE RS210

FDA 510(k)

FDA Class 2 ·Radiology

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