INNO SLA Mini Plus® Implant System

FDA 510(k)

FDA Class 2 ·Dental

SECULOK™ ACP System

FDA 510(k)

FDA Class 2 ·Orthopedic

E-CUBE 8

FDA 510(k)

FDA Class 2 ·Radiology

MiroCam Capsule Endoscope System

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

V8 Diagnostic Ultrasound System

FDA 510(k)

FDA Class 2 ·Radiology

Bright Bond Universal

FDA 510(k)

FDA Class 2 ·Dental

InBody

FDA 510(k)

FDA Class 2 ·Cardiovascular

Compressible Limb and Circulation Therapy System

FDA 510(k)

FDA Class 2 ·Physical Medicine

SD A1cCare System, SD A1cCare Spoit Type Test Kit, SD HbA1c Control Set

FDA 510(k)

FDA Class 2 ·Hematology

Amber Mill Series and Amber Press Series

FDA 510(k)

FDA Class 2 ·Dental

Fractional CO2 Surgical Laser System

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

Sonix Health

FDA 510(k)

FDA Class 2 ·Radiology

DVAS (DVAS-M, DVAS-W)

FDA 510(k)

FDA Class 2 ·Dental

LOSPA IS TLIF & DLIF Cages

FDA 510(k)

FDA Class 2 ·Orthopedic

HANAROSTENT LowAxTM Colon/Rectum (NNN), HANAROSTENT LowAxTM Duodenum/Pylorus (NNN)

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

TSIII BA Fixture

FDA 510(k)

FDA Class 2 ·Dental

V-Laser

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

Multi-unit Abutment, Multi-unit Angled Abutment

FDA 510(k)

FDA Class 2 ·Dental

Finetest Lite Smart Blood Glucose Monitoring System

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

1212FCA

FDA 510(k)

FDA Class 2 ·Radiology