Single Use Biopsy Forceps FB-456D

FDA 510(k)

FDA Class 2 ·Ear, Nose, Throat

SKR 3000

FDA 510(k)

FDA Class 2 ·Radiology

ECHELON Synergy MRI system

FDA 510(k)

FDA Class 2 ·Radiology

Evis Exera III Duodenovideoscope Olympus TJF-Q190V

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

SKR 3000

FDA 510(k)

FDA Class 2 ·Radiology

Visera Elite II Video System Center

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

Single Use Reloadable Clip Applicator (HX-810LR, HX-810UR); Clip (HX-610-090, HX-610-135); Long Clip (HX-610-090L, HX-610-135L); Short Clip (HX-610-090S, HX-610-135S); Super Short Clip (HX-610-135XS)

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

POTABLE AIR MASSAGER PUTIFINO, MODEL AM-7

FDA 510(k)

FDA Class 2 ·Physical Medicine

Vantage Orian 1.5T, MRT-1550, V4.5

FDA 510(k)

FDA Class 2 ·Radiology

iMedium Single Step; iMedium Single Step with HSA; iMedium Single Step with rHA

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

ULTRASONIC PROBE UM-S20-17S (UM-S20-17S); ULTRASONIC PROBE UM-S20-20R (UM-S20-20R)

FDA 510(k)

FDA Class 2 ·Radiology

Aplio i900/i800/i700 Diagnostic Ultrasound System, Software V7.0

FDA 510(k)

FDA Class 2 ·Radiology

XIDF-AWS801, Angio Workstation (Alphenix Workstation), V9.5

FDA 510(k)

FDA Class 2 ·Radiology

Aquilion ONE Vision, v7.0

FDA 510(k)

FDA Class 2 ·Radiology

PROBEAT-CR

FDA 510(k)

FDA Class 2 ·Radiology

Single Use Cytology Brush BC-205D

FDA 510(k)

FDA Class 2 ·Ear, Nose, Throat

VISERA 4K UHD SYSTEM

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

Xario 200 Diagnostic Ultrasound System V5.0

FDA 510(k)

FDA Class 2 ·Radiology

Vantage Fortian/Orian 1.5T, MRT-1550, V8.0 with AiCE Reconstruction Processing Unit for MR

FDA 510(k)

FDA Class 2 ·Radiology

Single Use Injector NM600/610

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology