Vantage Elan 1.5T, V4.0

FDA 510(k)

FDA Class 2 ·Radiology

XIDF - AWS801, Angio Workstation (Alphenix Workstation), V8.0

FDA 510(k)

FDA Class 2 ·Radiology

Vantage Orian 1.5T, MRT-1550, V6.0 with AiCE Reconstruction Processing Unit for MR

FDA 510(k)

FDA Class 2 ·Radiology

Disposable Syringe (Kit); Nemoto Disposable Syringe (Kit)

FDA 510(k)

FDA Class 2 ·Cardiovascular

ROKI Surgical Mask

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

Kenz Cardico1211

FDA 510(k)

FDA Class 2 ·Cardiovascular

CLEARFIL Universal Bond Quick 2

FDA 510(k)

FDA Class 2 ·Dental

ESTELITE BULK FILL Flow

FDA 510(k)

FDA Class 2 ·Dental

PANAVIA SA Cement Plus Automix; (Universal(A2), White, Translucent); Value Pack (Universal(A2), Translucent); Automix Trial (Universal(A2), White, Translucent); Mixing tip; Endo tip (SS)

FDA 510(k)

FDA Class 2 ·Dental

Small Field Applicator

FDA 510(k)

FDA Class 2 ·Radiology

JMS APHERESIS NEEDLE SET ACCORDION TYPE

FDA 510(k)

FDA Class 2 ·General Hospital

Vitrea Software Package, VSTP-001A

FDA 510(k)

FDA Class 2 ·Radiology

Nihon Kohden Vital Sign Telemeter

FDA 510(k)

FDA Class 2 ·Cardiovascular

Vantage Titan 1.5T, MRT-1510, V3.6 Software

FDA 510(k)

FDA Class 2 ·Radiology

Aquilion ONE Self-Propelled Scan Base Kit for IVR-CT, CGBA-034A

FDA 510(k)

FDA Class 2 ·Radiology

15-INCH (38 CM) COLOR LCD MONITOR CDL1576A

FDA 510(k)

FDA Class 2 ·Radiology

SION blue PLUS

FDA 510(k)

FDA Class 2 ·Cardiovascular

Single Use Retrieval Nitinol Basket V

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

FILTRYZER

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

2.3MP Color LCD Monitor, RadiForce MX242W

FDA 510(k)

FDA Class 2 ·Radiology