MODIFICATION TO DBB-05 HEMODIALYSIS DELIVERY SYSTEM

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

SKR 3000

FDA 510(k)

FDA Class 2 ·Radiology

Single Use Electrosurgical Knife KD-625 , Single Use Electrosurgical Knife KD-645

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

Aquilion Precision (TSX-304A/2) V8.6 with FIRST 3.0

FDA 510(k)

FDA Class 2 ·Radiology

Vantage Galan 3T, MRT-3020, V6.0

FDA 510(k)

FDA Class 2 ·Radiology

URETERO-RENO VIDEOSCOPE OLYMPUS URF-V3/V3R, URETERO-RENO FIBERSCOPE OLYMPUS URF-P7/P7R

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

ELEC-MATE E

FDA 510(k)

FDA Class 1 ·Dental

Disposable Distal Attachment D-201 Series

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

2MP MONOCHROME LCD MONITOR, RADIFORCE GX240

FDA 510(k)

FDA Class 2 ·Radiology

Single Use Cannula V PR-V223Q/V414Q/V416Q/V418Q/V420Q/V427Q/V434Q/V435Q; Single Use 2-Lumen Cannula V PR-V614M

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

KOWA KT-800

FDA 510(k)

FDA Class 2 ·Ophthalmic

21.3-INCH (54CM) MONOCHROME LCD MONITOR, MODELS MDL2109A, ME251I & DV2MM-HB

FDA 510(k)

FDA Class 2 ·Radiology

Disposal Lens Cleaning Sheath

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

ECHELON Oval V6.2 MRI System

FDA 510(k)

FDA Class 2 ·Radiology

Vantage Galan 3T, MRT-3020, V8.0 with AiCE Reconstruction Processing Unit for MR

FDA 510(k)

FDA Class 2 ·Radiology

DIGITAL RADIOGRAPHY CXDI-702C Wireless, DIGITAL RADIOGRAPHY CXDI-402C Wireless

FDA 510(k)

FDA Class 2 ·Radiology

DIRECT DIGITIZER REGIUS MODEL 370

FDA 510(k)

FDA Class 2 ·Radiology

HAL for Medical Use(Lower Limb type)

FDA 510(k)

FDA Class 2 ·Physical Medicine

PRESS DUO elite, PRESS DUO elite AG

FDA 510(k)

FDA Class 2 ·Cardiovascular

SPOT RETINOSCOPE RX-3SP

FDA 510(k)

FDA Class 1 ·Ophthalmic