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

FDA 510(k)

FDA Class 2 ·Dental

MODIFICATION TO FOCUS

FDA 510(k)

FDA Class 2 ·Dental

PHOT-X II, MODEL 303

FDA 510(k)

FDA Class 2 ·Dental

SCANRITE DFS

FDA 510(k)

FDA Class 2 ·Dental

Unit, X-Ray, Extraoral With Timer

FDA classification

FDA Class 2 ·Unit, X-Ray, Extraoral With Timer

Elecsys AMH

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

Elecsys TSH

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

Elecsys Tg II

FDA 510(k)

FDA Class 2 ·Immunology

ELECSYS FT4 II ASSAY, ELECSYS FT4 II CALSET

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

Elecsys AMH, AMH CalSet, PreciControl AMH, AMH CalCheck 5

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

Elecsys Digoxin Immunoassay, Elecsys PreciControl Cardiac II

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

HP-3 HD ELECTRIC WHEELCHAIR

FDA 510(k)

FDA Class 2 ·Physical Medicine

Catheters, Transluminal Coronary Angioplasty, Percutaneous

FDA Pre-Market Approval

FDA Class 2 ·FLEXTOME CUTTING BALLOON MONORAIL

OptiCross, OptiCross HD, OptiCross 6, OptiCross 6 HD

FDA 510(k)

FDA Class 2 ·Cardiovascular

OptiCross 6 HD, 60 MHz Coronary Imaging Catheter (Paper DFU), OptiCross 6 HD, 60 MHz Coronary Imaging Catheter (e-DFU)

FDA 510(k)

FDA Class 2 ·Cardiovascular

NASALGUARD

FDA 510(k)

FDA Class 2 ·General Hospital

MIND MAP (20 CHANNEL EEG)

FDA 510(k)

FDA Class 2 ·Neurology

HYUNJAE DENTAL IMPRESSION MATERIALS

FDA 510(k)

FDA Class 2 ·Dental

JIAJIAN SELF-ADHESIVE ELECTRODE

FDA 510(k)

FDA Class 2 ·Neurology

DYNAMIC GAS SCAVENGING SYSTEM (DGSS)

FDA 510(k)

FDA Class 2 ·Anesthesiology