FreeStyle Libre 3 Continuous Glucose Monitoring System

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

FreeStyle Libre 2 Flash Glucose Monitoring System

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

FreeStyle Libre 2 Flash Glucose Monitoring System (with FreeStyle Libre 2 App)

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

Bigfoot Unity® Diabetes Management System

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

FreeStyle Libre 2 System, FreeStyle Libre 3 System

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

FreeStyle Libre 3 Continuous Glucose Monitoring System

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

FreeStyle Libre 2 Flash Glucose Monitoring System

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

Bigfoot Unity Diabetes Management System

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

Illuminator, Non-Remote

FDA classification

FDA Class 2 ·Illuminator, Non-Remote

Valve, Non-Rebreathing

FDA classification

FDA Class 2 ·Valve, Non-Rebreathing

Calcium Salt Bone Void Filler, Drillable, Non-Screw Augmentation

FDA Pre-Market Approval

FDA Class 2 ·PRO OSTEON IMPLANT 500 HYDROXYAPATITE BONE VOID FILLER

Legging, Compression, Non-Inflatable

FDA classification

FDA Class 2 ·Legging, Compression, Non-Inflatable

Sigmoidoscope, Rigid, Non-Electrical

FDA classification

FDA Class 2 ·Sigmoidoscope, Rigid, Non-Electrical

Ventilator, Non-Continuous (Respirator)

FDA classification

FDA Class 2 ·Ventilator, Non-Continuous (Respirator)

Non-Coring (Huber) Needle

FDA classification

FDA Class 2 ·Non-Coring (Huber) Needle

Non-Stainless Steel Needle

FDA classification

FDA Class 2 ·Non-Stainless Steel Needle

Meter, Conductivity, Non-Remote

FDA classification

FDA Class 2 ·Meter, Conductivity, Non-Remote

Catheter, Hemodialysis, Non-Implanted

FDA classification

FDA Class 2 ·Catheter, Hemodialysis, Non-Implanted

Vaporizer, Anesthesia, Non-Heated

FDA classification

FDA Class 2 ·Vaporizer, Anesthesia, Non-Heated

Camera, Ophthalmic, Non-Prescription

FDA classification

FDA Class 2 ·Camera, Ophthalmic, Non-Prescription