OSSTEM Implant System

FDA 510(k)

FDA Class 2 ·Dental

RFA-1717DIG, RFA-1717DIC

FDA 510(k)

FDA Class 2 ·Radiology

ArtiSential Trocar

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

ELRA Electrode

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

ZENEX Implant System_Narrow

FDA 510(k)

FDA Class 2 ·Dental

Ear-Friendly Mask

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

HERA W9, HERA W10 Diagnostic Ultrasound System

FDA 510(k)

FDA Class 2 ·Radiology

MEDINAUT Plus

FDA 510(k)

FDA Class 2 ·Orthopedic

ARIX Ankle Distal Tibia System

FDA 510(k)

FDA Class 2 ·Orthopedic

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

FDA 510(k)

FDA Class 2 ·Radiology

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

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