GM85

FDA 510(k)

FDA Class 2 ·Radiology

TiGer Shark™ System

FDA 510(k)

FDA Class 2 ·Orthopedic

TITAN 11

FDA 510(k)

FDA Class 2 ·Radiology

LIFESTENT LP SDS BILIARY ENDOPROSTHESIS

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

PICASSO MASTER, ECT AND MASTER 3D

FDA 510(k)

FDA Class 2 ·Radiology

HANAROSTENT Esophagus TTS (CCC), HANAROSTENT Esophagus TTS (NCN)

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

ChoiceSpine Stealth Cervical Spacer System

FDA 510(k)

FDA Class 2 ·Orthopedic

4CIS® Marlin ACIF Cage System

FDA 510(k)

FDA Class 2 ·Orthopedic

THERMO-FLOW SET

FDA 510(k)

FDA Class 2 ·Anesthesiology

HANAROSTENT FASTTM Biliary (NNN)

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

WIRE, GUIDE, CATHETER

FDA 510(k)

FDA Class 2 ·Cardiovascular

Oneday Implant Abutment

FDA 510(k)

FDA Class 2 ·Dental

DIGITAL FLAT PANEL X-RAY DETECTOR / 1717G, XMARU1717G

FDA 510(k)

FDA Class 2 ·Radiology

MCOMPASS ANORECTAL MANOMETRY SYSTEM

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

Poseidon OCT Spinal Fixation System

FDA 510(k)

FDA Class 2 ·Orthopedic

DIGITAL FLAT PANEL X-RAY DETECTOR/1417WCA

FDA 510(k)

FDA Class 2 ·Radiology

Kosmos

FDA 510(k)

FDA Class 2 ·Radiology

LORENZ FIDUCAIL SCREW

FDA 510(k)

FDA Class 2 ·Neurology

IMC INSULIN SYRINGE

FDA 510(k)

FDA Class 2 ·General Hospital

JASPER Spinal Fixation System

FDA 510(k)

FDA Class 2 ·Orthopedic