TCM400

FDA 510(k)

FDA Class 2 ·Anesthesiology

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

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

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

Liquid Chromatography, Methadone

FDA classification

FDA Class 2 ·Liquid Chromatography, Methadone

Monitor, Carbon-Dioxide, Cutaneous

FDA Pre-Market Approval

FDA Class 2 ·LITTON TRANSCUTANEOUS CO2 SYSTEM

inVizia Anterior Certical Plate System, SC-AcuFix Ant-Cer Dynamic Cervical Plating System, SC-AcuFix Slimline Anterior Cervical Plate System, SC-AcuFix Thinline Anterior Cervical Plate System, Trinica Anterior Lumbar Plate System, Trinica and Trinica Select Anterior Cervical Plate System, V2F Anterior Fixation System

FDA 510(k)

FDA Class 2 ·Orthopedic

Catheters, Transluminal Coronary Angioplasty, Percutaneous

FDA Pre-Market Approval

FDA Class 2 ·SCIMED PTCA DILATATION CATHETER-ACE ADVANTAGE(TM)

Catheters, Transluminal Coronary Angioplasty, Percutaneous

FDA Pre-Market Approval

FDA Class 2 ·SCIMED(R) PTCA CATHETER

Catheters, Transluminal Coronary Angioplasty, Percutaneous

FDA Pre-Market Approval

FDA Class 2 ·MICROSOFTRAC TM (PTCA) CATHETER

Catheters, Transluminal Coronary Angioplasty, Percutaneous

FDA Pre-Market Approval

FDA Class 2 ·SCIMED PTCA CATHETER

Catheters, Transluminal Coronary Angioplasty, Percutaneous

FDA Pre-Market Approval

FDA Class 2 ·SCIMED PTCA DILATATION CATHETER-ACE ADVANTAGE(TM)

Catheters, Transluminal Coronary Angioplasty, Percutaneous

FDA Pre-Market Approval

FDA Class 2 ·SCIMED(R) PTCA CATHETER

Catheters, Transluminal Coronary Angioplasty, Percutaneous

FDA Pre-Market Approval

FDA Class 2 ·FLEXTOME & CUTTING BALLOON ULTRA