Kit, Test, Alpha-Fetoprotein For Neural Tube Defects

FDA Pre-Market Approval

FDA Class 3 ·ACCESS AFB REAGENTS ON THE ACCESS IMMUNOASSAY SYSTEMS

Total, Prostate Specific Antigen (Noncomplexed & Complexed) For Detection Of Prostate Cancer

FDA Pre-Market Approval

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

Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Metal/Polymer, Mobile Bearing

FDA Pre-Market Approval

FDA Class 3 ·LCS(R) TOTAL KNEE SYSTEM

Drug Eluting Permanent Right Ventricular (Rv) Or Right Atrial (Ra) Pacemaker Electrodes

FDA Pre-Market Approval

FDA Class 3 ·CapSure Sense Lead

Implantable Pulse Generator, Pacemaker (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·NG3 ICDS, ORIGEN, INOGEN, DYNAGEN EL; NG2.5 ICDS -ORIGEN, INOGEN, DYNAGEN MINI ICDS

Coronary Drug-Eluting Stent

FDA Pre-Market Approval

FDA Class 3 ·Resolute Onyx Zotarolimus-Eluting Coronary Stent System

Stimulator, Electrical, Implantable, For Incontinence

FDA Pre-Market Approval

FDA Class 3 ·SNS URINARY NEUROSTIMULATOR IMPLANTABLE INTERSTIM FAMILY

Coronary Drug-Eluting Stent

FDA Pre-Market Approval

FDA Class 3 ·ION PACLITAXEL-ELUTING PLATINUM CHROMIUM CORONARY STENT SYSTEM

Intraocular Lens

FDA Pre-Market Approval

FDA Class 3 ·TECNIS® Foldable Acrylic IOL

Implantable Pulse Generator, Pacemaker (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·NG3 CRT-D, DYNAGEN, DYNAGEN X4, INOGEN, INOGEN X4, ORIGEN, ORIGEN X4

Test, Hepatitis B (B Core, Be Antigen, Be Antibody, B Core Igm)

FDA Pre-Market Approval

FDA Class 3 ·ARCHITECT HBSAG QUALITTATIVE/CONFIRMATORY

Permanent Defibrillator Electrodes

FDA Pre-Market Approval

FDA Class 3 ·Sprint Quattro Lead

Intraocular Lens

FDA Pre-Market Approval

FDA Class 3 ·Collamer Intraocular Lens

Device, Incontinence, Mechanical/Hydraulic

FDA Pre-Market Approval

FDA Class 3 ·AMS 800 Artificial Urinary Sphincter (AUS) with InhibiZone Treatment

Agent, Absorbable Hemostatic, Collagen Based

FDA Pre-Market Approval

FDA Class 3 ·SURGIFOAM Absorbable Gelatin Sponge

Pulse Generator, Pacemaker, Implantable, With Cardiac Resynchronization (Crt-P)

FDA Pre-Market Approval

FDA Class 3 ·Valitude CRT-P, Valitude X4 CRT-P, Visionist CRT-P, and Visionist X4 CRT-P

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

FDA Pre-Market Approval

FDA Class 3 ·ARCHITECT FREE PSA

Device, Incontinence, Mechanical/Hydraulic

FDA Pre-Market Approval

FDA Class 3 ·AMS 800 Artificial Urinary Sphincter with InhibiZone™

Implantable Pacemaker Pulse-Generator

FDA Pre-Market Approval

FDA Class 3 ·Verity 5056, 5156, 5256, 5356, 5456, 5816; Zephyr 5826, 5626; Identity 5286, 5386; Sustain XL PM1134, PM1136, PM2134, PM

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·SICD Gen 2, SICD MRI