MAMMAPRINT

FDA 510(k)

FDA Class 2 ·Immunology

LungQ v3.0.0

FDA 510(k)

FDA Class 2 ·Radiology

LungQ Software

FDA 510(k)

FDA Class 2 ·Radiology

MAMMAPRINT

FDA 510(k)

FDA Class 2 ·Immunology

MODIFICATION TO MAMMAPRINT

FDA 510(k)

FDA Class 2 ·Immunology

Transpara (2.1.0)

FDA 510(k)

FDA Class 2 ·Radiology

Catheter (Gastric, Colonic, Etc.), Irrigation And Aspiration

FDA classification

FDA Class 2 ·Catheter (Gastric, Colonic, Etc.), Irrigation And Aspiration

Needle, Emergency Airway

FDA classification

FDA Class 2 ·Needle, Emergency Airway

Controller, Temperature, Cardiopulmonary Bypass

FDA classification

FDA Class 2 ·Controller, Temperature, Cardiopulmonary Bypass

CO2 Laser Machine (Lume)

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

Ultrasound, Skin Permeation

FDA classification

FDA Class 2 ·Ultrasound, Skin Permeation

Oral Electronic Vision Aid

FDA classification

FDA Class 2 ·Oral Electronic Vision Aid

Lasers For Temporary Increase Of Clear Nail In Patients With Onychomycosis

FDA classification

FDA Class 2 ·Lasers For Temporary Increase Of Clear Nail In Patients With Onychomycosis

Aid, Cardiopulmonary Resuscitation

FDA classification

FDA Class 2 ·Aid, Cardiopulmonary Resuscitation

Ultrasonic Body Composition Analyzer

FDA classification

FDA Class 2 ·Ultrasonic Body Composition Analyzer

Filler, Bone Void, Alterable Compound For Cranioplasty

FDA classification

FDA Class 2 ·Filler, Bone Void, Alterable Compound For Cranioplasty

Filler, Bone Void, Non-Alterable Compound For Cranioplasty

FDA classification

FDA Class 2 ·Filler, Bone Void, Non-Alterable Compound For Cranioplasty

Camera, Ophthalmic, General-Use

FDA classification

FDA Class 2 ·Camera, Ophthalmic, General-Use