E-CUBE 15 Diagnostic Ultrasound System

FDA 510(k)

FDA Class 2 ·Radiology

HANAROSTENT Trachea/Bronchium (CCC)

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

DENTRIa series (DENTRIa, DENTRI-Ca, DENTRI-Sa)

FDA 510(k)

FDA Class 2 ·Radiology

RCT800

FDA 510(k)

FDA Class 2 ·Radiology

Air Gap Fiber

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

GLUCODR PLUS SYSTEM, MODEL AGM-3000

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

Oneday Mini Implant System

FDA 510(k)

FDA Class 2 ·Dental

MAHE FIXATION PLATE AND SCREW SYSTEM

FDA 510(k)

FDA Class 2 ·Orthopedic

ARIX Foot System

FDA 510(k)

FDA Class 2 ·Orthopedic

GA-B, GA-C, GA-E, GA-I, GA-S, GA-W3A, GA-F3A, GA-IL, GA-SL, GA-W3B, GA-F1A

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

Perpak™ Sterilization Tyvek Pouch

FDA 510(k)

FDA Class 2 ·General Hospital

JLK-CTP

FDA 510(k)

FDA Class 2 ·Radiology

ACURA PLUS MULTI BLOOD GLUCOSE MONITORING SYSTEM

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

MIROCAM CAPSULE ENDOSCOPE SYSTEM

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

Xcam

FDA 510(k)

FDA Class 2 ·Dental

EVS 2430W, EVS 2430GW

FDA 510(k)

FDA Class 2 ·Radiology

Well-life TM Pen Needles, Well-life TM Safety Pen Needles

FDA 510(k)

FDA Class 2 ·General Hospital

s-Clean OneQ-SL Narrow Implant System

FDA 510(k)

FDA Class 2 ·Dental

X-CUBE i8, X-CUBE i9

FDA 510(k)

FDA Class 2 ·Radiology

EzDent-i / E2 / Prora View / Smart M Viewer (v3.5)

FDA 510(k)

FDA Class 2 ·Radiology