Smart SPACE Shoulder Planner and 3D Positioners

FDA 510(k)

FDA Class 2 ·Orthopedic

SUNGLASSES

FDA 510(k)

FDA Class 1 ·Ophthalmic

Duetto Suprema; Domino Suprema; Suprema VT; Suprema VT+; Suprema 4V

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

LIFEJET PRINTER 400

FDA 510(k)

FDA Class 2 ·Radiology

I-View Gold and Imagen Gold Dental Sensors

FDA 510(k)

FDA Class 2 ·Dental

Physica KR Liner and SMR Reverse Humeral Liner

FDA 510(k)

FDA Class 2 ·Orthopedic

Blood Collection Needles

FDA 510(k)

FDA Class 2 ·General Hospital

BE Plus PRO, Neurotravel LIGHT

FDA 510(k)

FDA Class 2 ·Neurology

Family of Steam Sterilizers B 28 series

FDA 510(k)

FDA Class 2 ·General Hospital

BRM TOOL Screws, BIOPLAN Subtalar Implant

FDA 510(k)

FDA Class 2 ·Orthopedic

Youlaser CO2

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

Color Liquid, Vita Liquid

FDA 510(k)

FDA Class 2 ·Dental

MTS Levofloxacin 0.002 - 32 µg/mL

FDA 510(k)

FDA Class 2 ·Microbiology

ENA TEMP AND ENAMEL PLUS TEMP (TWO DIFFERENT PROPRIETARY NAMES FOR THE SAME PRODUCT)

FDA 510(k)

FDA Class 2 ·Dental

Liofilchem MIC Test Strip (MTS)- Delafloxacin 0.002 - 32 µg/mL

FDA 510(k)

FDA Class 2 ·Microbiology

PIEZOSURGERY MEDICAL

FDA 510(k)

FDA Class 2 ·Orthopedic

LUBRIGYN CREAM

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

ZIRKONZAHN.Implant-Planner, ZIRKONZAHN.Implant-Planner Practice, CAD/CAM STL Converter, CAD/CAM Z-Tray

FDA 510(k)

FDA Class 2 ·Radiology

LITHO LASER SYSTEM

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

6430 MyLabX75, 6430 MyLab XPro75

FDA 510(k)

FDA Class 2 ·Radiology