Sensor, Glucose, Invasive

FDA Pre-Market Approval

FDA Class 3 ·FreeStyle Libre Pro Flash Glucose Monitoring System

Agent, Absorbable Hemostatic, Collagen Based

FDA Pre-Market Approval

FDA Class 3 ·SUPERSTAT

Heart-Valve, Non-Allograft Tissue

FDA Pre-Market Approval

FDA Class 3 ·MITRIS RESILIA Mitral Valve

Agent, Bulking, Injectable For Gastro-Urology Use

FDA Pre-Market Approval

FDA Class 3 ·DEFLUX INJECTABLE GEL

Implantable Pacemaker Pulse-Generator

FDA Pre-Market Approval

FDA Class 3 ·MODEL 3033C FUNCTION PACT

Intraocular Lens

FDA Pre-Market Approval

FDA Class 3 ·ONE PIECE POSTERIOR CHAMBER INTRAOCULAR LENS

Implant, Cochlear

FDA Pre-Market Approval

FDA Class 3 ·HARMONY HIRESOLUTION BIONIC EAR SYSTEM

Replacement Heart-Valve

FDA Pre-Market Approval

FDA Class 3 ·HANCOCK APICAL LEFT VENTRICLE CONNECTOR

Test, Prostate Specific Antigen, Free, (Noncomplexed) To Distinguish Prostate Cancer From Benign Conditions

FDA Pre-Market Approval

FDA Class 3 ·ACCESS HYBRITECH FREE PSA REAGENTS ON THE ACCESS IMMUNOASSAY SYSTEMS

Stent, Carotid

FDA Pre-Market Approval

FDA Class 3 ·RX ACCULINK CAROTID STENT SYSTEM

Prosthesis, Breast, Inflatable, Internal, Saline

FDA Pre-Market Approval

FDA Class 3 ·SALINE-FILLED BREAST IMPLANTS

System, Endovascular Graft, Aortic Aneurysm Treatment

FDA Pre-Market Approval

FDA Class 3 ·AFX ENDOVASCULAR AAA SYSTEM

System, Endovascular Graft, Aortic Aneurysm Treatment

FDA Pre-Market Approval

FDA Class 3 ·POWERLINK SYSTEM

Implantable Pacemaker Pulse-Generator

FDA Pre-Market Approval

FDA Class 3 ·TEMPO PULSE GENERATORS

Sealant, Polymerizing

FDA Pre-Market Approval

FDA Class 3 ·PROGEL PLEURAL AIR LEAK SEALANT, PROGEL EXTENDED APPLICATOR SPRAY TIP16CM/6IN, PROGEL EXTENDED APPLICATOR SPRAY TIP29CM/

Prosthesis, Breast, Inflatable, Internal, Saline

FDA Pre-Market Approval

FDA Class 3 ·MENTOR SALINE-FILLED/SPECTRUM MAMMARY PROSTHESES

Cardiac Ablation Percutaneous Catheter

FDA Pre-Market Approval

FDA Class 3 ·THERAPY/THERAPY BI-DIRECTIONAL/THERAPY 4MM THERMISTOR ABLATION CATHETERS

Prosthesis, Breast, Inflatable, Internal, Saline

FDA Pre-Market Approval

FDA Class 3 ·Mentor Saline-Filled and Spectrum Breast Implants

Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Flutter

FDA Pre-Market Approval

FDA Class 3 ·THERAPY DUAL 8 CARDIAC ABLATION SYSTEM,THERAM 8MM THERMISTER ABLATION CATHETER SAFIRE TX ABLATION CATHETER

Absorbable Coronary Drug-Eluting Stent

FDA Pre-Market Approval

FDA Class 3 ·ABSORB GT1 BIORESORBABLE VASCULAR SCAFFOLD (BVS) SYSTEM