HDL-EX SEIKEN ASSAY KIT

FDA 510(k)

FDA Class 1 ·Clinical Chemistry

General Cutting Contra Handpiece

FDA 510(k)

FDA Class 1 ·Dental

Digital Radiography CXDI-Pro, Digital Radiography D1

FDA 510(k)

FDA Class 2 ·Radiology

Aquilion Serve SP (TSX-307B/1) V1.3

FDA 510(k)

FDA Class 2 ·Radiology

VASSALLO GT

FDA 510(k)

FDA Class 2 ·Cardiovascular

CRP-LATEX (II)X2 SEIKEN ASSAY KIT

FDA 510(k)

FDA Class 2 ·Immunology

Mini Ridge Filter and auxiliary functions for PROBEAT-V

FDA 510(k)

FDA Class 2 ·Radiology

Aplio i900, Aplio i800 and Aplio i700 Software V8.1 Diagnostic Ultrasound System

FDA 510(k)

FDA Class 2 ·Radiology

MOBILE X-RAY SYSTEM

FDA 510(k)

FDA Class 2 ·Radiology

ReBOSSIS85

FDA 510(k)

FDA Class 2 ·Orthopedic

Ultimax-i, DREX-UI80 (V1.60)

FDA 510(k)

FDA Class 2 ·Radiology

Low Dose Lung Screening Option

FDA 510(k)

FDA Class 2 ·Radiology

E-TYPE SPEED REDUCER CONTRA ANGLE

FDA 510(k)

FDA Class 2 ·Dental

SONIC SCALER WITH FIBER OPTIC, MODEL NAS-L, SONIC SCALER WITHOUT FIBER OPTIC, MODEL NAS-NL

FDA 510(k)

FDA Class 2 ·Dental

ASAHI Corsair Microcatheter

FDA 510(k)

FDA Class 2 ·Cardiovascular

Metacross RX PTA Balloon Dilitation Catheter

FDA 510(k)

FDA Class 2 ·Cardiovascular

ZIMLITE LENS

FDA 510(k)

FDA Class 1 ·Ophthalmic

Aquilion Lightning, TSX-036A/1, V8.4

FDA 510(k)

FDA Class 2 ·Radiology

Specular Microscope CEM-530

FDA 510(k)

FDA Class 2 ·Ophthalmic

3D OPTICAL COHERENCE TOMOGRAPHY 3D OCT-1(type: Maestro2)

FDA 510(k)

FDA Class 2 ·Ophthalmic