K-SHIELD Zen (Model Numbers: PBMH/ PBMA/ PBM)

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

Bel-Cypher Pro

FDA 510(k)

FDA Class 2 ·Dental

K-SHIELD Zen

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

SB Knife Jr type, SB Knife Short type, SB Knife Standard type, SB Knife Jr type - Long

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

Kitazato ET Catheters

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

3MP Color LCD Monitor (CL-S301)

FDA 510(k)

FDA Class 2 ·Radiology

ONIS-PACS

FDA 510(k)

FDA Class 2 ·Radiology

CLEARFIL UNIVERSAL BOND VALUE PACK, CLEARFIL UNIVERSALY BOND TRIAL, CLEARFIL UNIVERSAL BOND

FDA 510(k)

FDA Class 2 ·Dental

KATANA Zirconia Block

FDA 510(k)

FDA Class 2 ·Dental

PreXion3D Explorer EX

FDA 510(k)

FDA Class 2 ·Radiology

PreXion3D Explorer PRO

FDA 510(k)

FDA Class 2 ·Radiology

SCENARIA View Phase 5.0

FDA 510(k)

FDA Class 2 ·Radiology

Synapse 3D Base Tools v6.6

FDA 510(k)

FDA Class 2 ·Radiology

CLEARFIL CERAMIC PRIMER PLUS, CLEARFIL CERAMIC PRIMER PLUS (Trial)

FDA 510(k)

FDA Class 2 ·Dental

GLUCOCARD® W onyx Blood Glucose Monitoring System

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

CLEARFIL MAJESTY ES FLOW

FDA 510(k)

FDA Class 2 ·Dental

IMAGEnet6 Ophthalmic Data System

FDA 510(k)

FDA Class 2 ·Radiology

Esthetic Colorant

FDA 510(k)

FDA Class 2 ·Dental

OC-Auto SENSOR io iFOB Test

FDA 510(k)

FDA Class 2 ·Hematology

Mochida Nerve Cuff

FDA 510(k)

FDA Class 2 ·Neurology