ELEMENT-TL

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

Fundus Camera

FDA 510(k)

FDA Class 2 ·Ophthalmic

Mei Ceramic Bracket

FDA 510(k)

FDA Class 2 ·Dental

1417WGC_127um and 1417WGC_140um

FDA 510(k)

FDA Class 2 ·Radiology

HANAROSTENT LowAx Colon/Rectum (NNN)

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

PaX-i3D Green Premium (Model: PCT-90LH)

FDA 510(k)

FDA Class 2 ·Radiology

UniSpace® Stand-Alone C Cage

FDA 510(k)

FDA Class 2 ·Orthopedic

0909FCC, 0909FCC-HS

FDA 510(k)

FDA Class 2 ·Radiology

1717SCV, 1717SGV

FDA 510(k)

FDA Class 2 ·Radiology

Unispace SA Cervical Cage

FDA 510(k)

FDA Class 2 ·Orthopedic

Xmaru View V1 and Xmaru PACS, Medical Image Processing Software

FDA 510(k)

FDA Class 2 ·Radiology

I-CHROMA IFOB WITH I-CHROMA READER

FDA 510(k)

FDA Class 2 ·Hematology

Jeesung Safety Syringe and Single Use Needles

FDA 510(k)

FDA Class 2 ·General Hospital

EzRay Air 2 Wall (Model: VEX-S350W)

FDA 510(k)

FDA Class 2 ·Dental

Green16/Green18 (Model: PHT-65LHS)

FDA 510(k)

FDA Class 2 ·Radiology

FRAXIS DUO

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

ASPIRON ACP SYSTEM

FDA 510(k)

FDA Class 2 ·Orthopedic

STERI-OSS Implant System

FDA 510(k)

FDA Class 2 ·Dental

Velofix™ SA Cervical Cage

FDA 510(k)

FDA Class 2 ·Orthopedic

Powered Breast Pump (Models 7V and 7X)

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology