Green X 21 (PHT-90CHO)

FDA 510(k)

FDA Class 2 ·Radiology

EzSensor Soft, EzSensor Soft i, EzSensor Bio, and EzSensor Bio i

FDA 510(k)

FDA Class 2 ·Dental

Synergy Gold (SG) Portable (Models MM011450 and MM011460)

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

Jeesung Safety Syringe and Single Use Needles

FDA 510(k)

FDA Class 2 ·General Hospital

Dental Computed Tomography X-ray System, PHT-30LFO, PaX-i3D Smart

FDA 510(k)

FDA Class 2 ·Radiology

HANAROSTENT Trachea/Bronchium (CCC)

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

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

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

Dyna Locking Trochanteric Nail™

FDA 510(k)

FDA Class 2 ·Orthopedic

HANAROSTENT FASTTM Biliary (NNN)

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

ENDOSEAL MTA

FDA 510(k)

FDA Class 2 ·Dental

Smart Kit Basic, Smart Kit Pro

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

ANAX 5.5 SPINAL SYSTEM

FDA 510(k)

FDA Class 2 ·Orthopedic

Green Smart (Model: PHT-35LHS)

FDA 510(k)

FDA Class 2 ·Radiology

Digital Flat Panel X-ray Detector (1717WCE, 1717WCE-HR, 1717WCE-HS, 1717WCE-GF)

FDA 510(k)

FDA Class 2 ·Radiology

Fraxis

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

Green X 12 SE (PHT-40CHS)

FDA 510(k)

FDA Class 2 ·Radiology

EzRay M18 (Model: VMX-P400)

FDA 510(k)

FDA Class 2 ·Radiology

SECULOK™ ACP System

FDA 510(k)

FDA Class 2 ·Orthopedic

Digital Dental Intra Oral Sensor, EzSensor Classic, EzSensor HD, HDI-P, HDI-S

FDA 510(k)

FDA Class 2 ·Dental

ANAX 5.5™ Spinal System

FDA 510(k)

FDA Class 2 ·Orthopedic