CUBESCAN / BIOCON-700

FDA 510(k)

FDA Class 2 ·Radiology

PAPAYA 3D Premium & PAPAYA 3D Premium Plus

FDA 510(k)

FDA Class 2 ·Radiology

MINE ALNU (Model: Mine 2.1)

FDA 510(k)

FDA Class 2 ·Radiology

OneQ-SL s-Clean Implant System

FDA 510(k)

FDA Class 2 ·Dental

BLE Smart Blood Glucose Monitoring System, BLE Smart Professional Blood Glucose Monitoring System

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

OSSTEM Implant System - Abutment

FDA 510(k)

FDA Class 2 ·Dental

BSD3543 Digital Flat Panel X-ray Detector

FDA 510(k)

FDA Class 2 ·Radiology

HM70A Diagnostic Ultrasound System

FDA 510(k)

FDA Class 2 ·Radiology

CUTANEOUS ELECTRODES

FDA 510(k)

FDA Class 2 ·Neurology

I-SCOPE 200

FDA 510(k)

FDA Class 2 ·Cardiovascular

BODY COMPOSITION ANALYZER, EASYBODY 202, 203, 205

FDA 510(k)

FDA Class 2 ·Cardiovascular

Viola

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

V20, V20a, AVSM3 SNF

FDA 510(k)

FDA Class 2 ·Cardiovascular

DAEHAN Adhesive Surface Electrodes

FDA 510(k)

FDA Class 2 ·Neurology

s-Clean ScanHealing Abutment

FDA 510(k)

FDA Class 2 ·Dental

DYNA LOCKING ANKLE NAIL

FDA 510(k)

FDA Class 2 ·Orthopedic

LATEX SURGICAL GLOVES

FDA 510(k)

FDA Class 1 ·General, Plastic Surgery

JSM Insulin Pen Needle

FDA 510(k)

FDA Class 2 ·General Hospital

FP(HEXAFOCON A)RGP CONTACT LENS SPHERICAL/ASP(HEXAFOCON A)RGP CONTACT LENS ASPHERICAL

FDA 510(k)

FDA Class 2 ·Ophthalmic

Rexious Spinal Fixation System

FDA 510(k)

FDA Class 2 ·Orthopedic