ASAHI Silverway

FDA 510(k)

FDA Class 2 ·Cardiovascular

BLOOD TUBING LINES FOR HEMODIALYSIS AL Series (Archloop) BLOOD TUBING LINES FOR HEMODIALYSIS C18 Series AL-ADC-PU, AL-CDC-PU, C18RDC-PU, C18BDD-PU, C18SFD-PU

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

Multi-Lancet Device 2, ReliOn Premier Lancing Device

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

Over-tube (TR-1108A)

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

KOWA SL-17

FDA 510(k)

FDA Class 2 ·Ophthalmic

Aplio i900/i800/i700/i600 Diagnostic Ultrasound System, V3.1

FDA 510(k)

FDA Class 2 ·Radiology

MOTOR-DRIVE MANIPULATOR MM-89

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

Ophthalmic Yag Laser System YC-200

FDA 510(k)

FDA Class 2 ·Ophthalmic

K-ETCHANT SYRINGE; NEEDLE TIP (E)

FDA 510(k)

FDA Class 2 ·Dental

Vitrea Software Package; VSTP-001A

FDA 510(k)

FDA Class 2 ·Radiology

FDR Visionary Suite

FDA 510(k)

FDA Class 2 ·Radiology

RADIFORCE GX220 AND GS220 MONOCHROME LCD MONITORS

FDA 510(k)

FDA Class 2 ·Radiology

Vitrea Software Toshiba Package; VSTP-001A

FDA 510(k)

FDA Class 2 ·Radiology

Aquilion Exceed LB

FDA 510(k)

FDA Class 2 ·Radiology

Deep Learning Image Reconstruction

FDA 510(k)

FDA Class 2 ·Radiology

NIKKLINE BLOOD TUBING LINES WITH TRANSDUCER PROTECTORS, MODELS AV06A-P, AVO6B-P, AV06C-P

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

20.1 INCH (51 CM) COLOR LCD MONITOR CCL208 (CDL2013A)

FDA 510(k)

FDA Class 2 ·Radiology

Visera Hysterovideoscope Olympus HYF Type V

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

Synapse PACS

FDA 510(k)

FDA Class 2 ·Radiology

FLUOROspeed

FDA 510(k)

FDA Class 2 ·Radiology