Symani Surgical System

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

Guided Growth Plate System Plus

FDA 510(k)

FDA Class 2 ·Orthopedic

Dolphix® External Fixation System MR Conditional

FDA 510(k)

FDA Class 2 ·Orthopedic

HERO 1, MODEL LY-ESB220

FDA 510(k)

FDA Class 2 ·Physical Medicine

CO2 Laser System

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

DEKA HELIX

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

WU'S 3-WHEELED NEO SCOOTER, MODEL WT-T3E

FDA 510(k)

FDA Class 2 ·Physical Medicine

Yushan X-Ray Flat Panel Detector with DROC

FDA 510(k)

FDA Class 2 ·Radiology

MDT2 BLE Self-Monitoring Blood Glucose System

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

CONE MASKS, VARIOUS TYPES OF SURGICAL CONE MASKS

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

Heating TENS/EMS Device, FT-240-1, Heating TENS/EMS Device, FT-240-2

FDA 510(k)

FDA Class 2 ·Neurology

DIGITAL FOREHEAD THERMOMETER, MODEL# KD-2200

FDA 510(k)

FDA Class 2 ·General Hospital

PACK & PROPER PACK & PROPER, EAR-THERMOMETER PROBE CAP

FDA 510(k)

FDA Class 2 ·General Hospital

SavDenTM MTA Root Canal Filling Materials

FDA 510(k)

FDA Class 2 ·Dental

x-mind dc (under trademark Acteon), Owandy-RX DC (under trademark OwandyRadiology)

FDA 510(k)

FDA Class 2 ·Dental

SOLOV2 BLOOD GLUCOSE MONITORING SYSTEM

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

PixoTest POCT System - PixoTest POCT Analyzer and PixoTest A1c Test Kit

FDA 510(k)

FDA Class 2 ·Hematology

Perseus

FDA 510(k)

FDA Class 2 ·Neurology

CER-S

FDA 510(k)

FDA Class 2 ·Cardiovascular

Ultrasound Imaging System (LK128L); Ultrasound Imaging System (LK128LH); Ultrasound Imaging System (LK128C); Ultrasound Imaging System (LK128M); Ultrasound Imaging System (LK128PA); Ultrasound Imaging System (LK128E); Ultrasound Imaging System (LU700C); Ultrasound Imaging System (LU700L); Ultrasound Imaging System (LU710L); Ultrasound Imaging System (LU710LH); Ultrasound Imaging System (LU710C); Ultrasound Imaging System (LU710M); Ultrasound Imaging System (LU710PA); Ultrasound Imaging

FDA 510(k)

FDA Class 2 ·Radiology