EVS 3643, EVS 3643G

FDA 510(k)

FDA Class 2 ·Radiology

KetoSens BT Blood B-Ketone Monitoring System

FDA 510(k)

FDA Class 1 ·Clinical Chemistry

GXR-ES/ECS Diagnostic X-Ray System, (Models GXR-ES series, GXR-ECS series)

FDA 510(k)

FDA Class 2 ·Radiology

TDM Plate and Screw System

FDA 510(k)

FDA Class 2 ·Orthopedic

ACR Screw System

FDA 510(k)

FDA Class 2 ·Dental

TargetCool™

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

ANAX 5.5 SPINAL SYSTEM

FDA 510(k)

FDA Class 2 ·Orthopedic

MiNi Internal Implant System

FDA 510(k)

FDA Class 2 ·Dental

EVS 4343A, EVS 4343AG, EVS 3643A, EVS 3643AG

FDA 510(k)

FDA Class 2 ·Radiology

InBody

FDA 510(k)

FDA Class 2 ·Cardiovascular

TERA HARZ CLEAR

FDA 510(k)

FDA Class 2 ·Dental

VIVIX-S 1012N

FDA 510(k)

FDA Class 2 ·Radiology

SS Abutment System

FDA 510(k)

FDA Class 2 ·Dental

NB Mini Implant System

FDA 510(k)

FDA Class 2 ·Dental

IT-III active System

FDA 510(k)

FDA Class 2 ·Dental

E.G. SCAN II ESPHAGOSCOPE SYSTEM

FDA 510(k)

FDA Class 2 ·Ear, Nose, Throat

SMARTRION COMBI/Alexandrite & Long Pulsed Nd:YAG Laser

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

JLK-SDH

FDA 510(k)

FDA Class 2 ·Radiology

EGIS Biliary Single Bare Stent

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

ULC SPINAL PEDICLE SCREW SYSTEM

FDA 510(k)

FDA Class 2 ·Orthopedic