WAKO AUTOKIT LP(A)/DADE DEMENSION

FDA 510(k)

FDA Class 2 ·Immunology

Analyzer, Medical Image

FDA Pre-Market Approval

FDA Class 2 ·SECONDLOOK (SL) CAD

Analyzer, Medical Image

FDA Pre-Market Approval

FDA Class 2 ·IMAGE CHECKER CAD

Analyzer, Medical Image

FDA Pre-Market Approval

FDA Class 2 ·MAMMOGRAPHY CAD ENGINE

Analyzer, Medical Image

FDA Pre-Market Approval

FDA Class 2 ·SECONDLOOK (SL) CAD

Analyzer, Medical Image

FDA Pre-Market Approval

FDA Class 2 ·KODAK MAMMOGRAPHY CAD ENGINE

Analyzer, Medical Image

FDA Pre-Market Approval

FDA Class 2 ·KODAK MAMMOGRAPHY CAD ENGINE

Analyzer, Medical Image

FDA Pre-Market Approval

FDA Class 2 ·SECONDLOOK DIGITAL V7.2 CAD

PRO-GLASS

FDA 510(k)

FDA Class 2 ·Dental

LASEVAC

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

ELECTRONIC PULSE STIMULATOR

FDA 510(k)

FDA Class 2 ·Neurology

Wearable Breast Pump (Model S10)

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

Surgical Face Mask

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

Medical Face Mask

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

INTERMEZZO PLUS FIXTURE

FDA 510(k)

FDA Class 2 ·Dental

electrocardiograph: SE-1202

FDA 510(k)

FDA Class 2 ·Cardiovascular

iFlash-HCG; Chemiluminescence Immunoassay Analyzer (Model: iFlash 3000-C)

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

Disposable Laryngeal Electrodes

FDA 510(k)

FDA Class 2 ·Ear, Nose, Throat

Cloud Smart Thermometer

FDA 510(k)

FDA Class 2 ·General Hospital

RESCUE IMPLANT SYSTEM

FDA 510(k)

FDA Class 2 ·Dental