Enzyme Immunoassay, Fetal Fibronectin

FDA Pre-Market Approval

FDA Class 3 ·RAPID FFN FOR THE TLI SYSTEM

Enzyme Immunoassay, Fetal Fibronectin

FDA Pre-Market Approval

FDA Class 3 ·Rapid fFN for the TLiIQ System

Daily Wear Soft Contact Lens To Reduce The Progression Of Myopia

FDA Pre-Market Approval

FDA Class 3 ·MiSight 1 Day (omafilcon A)

Enzyme Immunoassay, Fetal Fibronectin

FDA Pre-Market Approval

FDA Class 3 ·TLiIQ QCette

Enzyme Immunoassay, Fetal Fibronectin

FDA Pre-Market Approval

FDA Class 3 ·Rapid fFN for the TLiIQ System, Fetal Fibronectin Enzyme Immunoassay

Implantable Pulse Generator, Pacemaker (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·GEMNOS(TM) 04 CARDIAC PACEMAKER & SWN 600/C00U02

Intraocular Lens

FDA Pre-Market Approval

FDA Class 3 ·OCUSIL(R) (NEFOCON A) CONTACT LENSES ADD FIN LABS

Device, Thermal Ablation, Endometrial

FDA Pre-Market Approval

FDA Class 3 ·Cerene Cryotherapy Device

Ventricular (Assist) Bypass

FDA Pre-Market Approval

FDA Class 3 ·ABIOMED(R) BVS 5000 BI-VENTRICULAR SUPPORT SYSTEM

Analyzer, Data, Obstetric

FDA Pre-Market Approval

FDA Class 3 ·STAN S31 FETAL HEART MONITOR

Prosthesis, Breast, Inflatable, Internal, Saline

FDA Pre-Market Approval

FDA Class 3 ·NATRELLE Saline-Filled Breast Implants

Prosthesis, Breast, Inflatable, Internal, Saline

FDA Pre-Market Approval

FDA Class 3 ·MCGHAN SALINE-FILLED BREAST IMPLANTS

Prosthesis, Breast, Inflatable, Internal, Saline

FDA Pre-Market Approval

FDA Class 3 ·Mentor Saline-Filled and SPECTRUM® Breast Implants

Prosthesis, Breast, Inflatable, Internal, Saline

FDA Pre-Market Approval

FDA Class 3 ·IDEAL IMPLANT SALINE-FILLED BREAST IMPLANT

Prosthesis, Breast, Inflatable, Internal, Saline

FDA Pre-Market Approval

FDA Class 3 ·SALINE-FILLED BREAST IMPLANTS

Prosthesis, Breast, Inflatable, Internal, Saline

FDA Pre-Market Approval

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

Prosthesis, Breast, Inflatable, Internal, Saline

FDA Pre-Market Approval

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

Prosthesis, Breast, Inflatable, Internal, Saline

FDA Pre-Market Approval

FDA Class 3 ·SALINE-FILLED & SPECTRUM BREAST IMPLANTS

Prosthesis, Breast, Inflatable, Internal, Saline

FDA Pre-Market Approval

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

Prosthesis, Breast, Inflatable, Internal, Saline

FDA Pre-Market Approval

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