INTRAcel Premium Fractional RF Micro Needle (FRM) System

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

PAPAYA 3D Plus

FDA 510(k)

FDA Class 2 ·Radiology

GM60A-32S & GM60A-40S

FDA 510(k)

FDA Class 2 ·Radiology

GEMSS Medical System Surgical Mobile Fluoroscopic X-ray System

FDA 510(k)

FDA Class 2 ·Radiology

PIXX 1717; PIXX 1417; PIXX 1212; Digital Diagnostic X-ray Receptor Panels

FDA 510(k)

FDA Class 2 ·Radiology

EXULT Knee Replacement System

FDA 510(k)

FDA Class 2 ·Orthopedic

DiaPaste

FDA 510(k)

FDA Class 2 ·Dental

BSD3543W

FDA 510(k)

FDA Class 2 ·Radiology

CARESENS N VOICE MULTI BLOOD GLUCOSE MONITORING SYSTEM, CARESENS N VOICE MULTI BLOOD GLUCOSE METER

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

Veuron-Brain-pAb2

FDA 510(k)

FDA Class 2 ·Radiology

ANESTHESIA INJECTION TOOL SET

FDA 510(k)

FDA Class 2 ·Dental

RS80A Diagnostic Ultrasound System

FDA 510(k)

FDA Class 2 ·Radiology

GLUCOCARD Shine Connex Blood Glucose Monitoring System, GLUCOCARD Shine Express Blood Glucose Monitoring System

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

AROMA GRAND

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

AVIEW

FDA 510(k)

FDA Class 2 ·Radiology

ArtiSential Laparoscopic Instruments-Electrodes

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

FM20

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

Lunit INSIGHT CXR Triage

FDA 510(k)

FDA Class 2 ·Radiology

Customized Abutment

FDA 510(k)

FDA Class 2 ·Dental

DIAETCH Economic Package Type A, DIATECH Regular Package, DIAETCH Refill Package Type A, DIAETCH Intro Kit

FDA 510(k)

FDA Class 2 ·Dental