Drug-Coated Peripheral Transluminal Angioplasty Catheter

FDA Pre-Market Approval

FDA Class 3 ·IN.PACT AV Paclitaxel-Coated Percutaneous Transluminal Angioplasty (PTA) Balloon

Prosthesis, Breast, Inflatable, Internal, Saline

FDA Pre-Market Approval

FDA Class 3 ·Puregraft Serene Breast Implant, IDEAL IMPLANT Structured Breast Implant

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·ENDOTAK RELIANCE 4-SITE LEAD AND ACCESSORY MODELS

Processor, Cervical Cytology Slide, Automated

FDA Pre-Market Approval

FDA Class 3 ·MONOPREP PAP TEST

Cardiac Ablation Percutaneous Catheter

FDA Pre-Market Approval

FDA Class 3 ·NAVISTAR AND CELSIUS THERMOCOOL CATHETERS

Barrier, Absorbable, Adhesion

FDA Pre-Market Approval

FDA Class 3 ·SEPRAFILM

Agent, Absorbable Hemostatic, Non-Collagen Based

FDA Pre-Market Approval

FDA Class 3 ·SURGICEL ABSORBABLE HEMOSTAT (SURGICEL, SURGICEL NU-KNIT AND SURGICEL FIBRILLAR ABSORBABLE HEMOSTATS)

Fluid, Intraocular

FDA Pre-Market Approval

FDA Class 3 ·PERFLUORON

Stimulator, Spinal-Cord, Totally Implanted For Pain Relief

FDA Pre-Market Approval

FDA Class 3 ·SENZA SPINAL CORD STIMULATION (SCS) SYSTEM

Catheter, Balloon, Urethral, Drug-Coated

FDA Pre-Market Approval

FDA Class 3 ·Optilume Urethral Drug Coated Balloon

Implanted Phrenic Nerve Stimulator For Central Sleep Apnea

FDA Pre-Market Approval

FDA Class 3 ·remede® System

Heart-Valve, Non-Allograft Tissue

FDA Pre-Market Approval

FDA Class 3 ·3F AORTIC BIOPROSTHESIS

Implant, Dermal, For Aesthetic Use

FDA Pre-Market Approval

FDA Class 3 ·Revanesse Ultra (Revanesse Versa)

System, Endovascular Graft, Aortic Aneurysm Treatment

FDA Pre-Market Approval

FDA Class 3 ·TREO Abdominal Stent-Graft System

Artificial Heart

FDA Pre-Market Approval

FDA Class 3 ·SynCardia temporary Total Artificial Heart (TAH-t) System

Stimulator, Low Electric Field, Tumor Treatment

FDA Pre-Market Approval

FDA Class 3 ·OPTUNE

Prosthesis, Breast, Noninflatable, Internal, Silicone Gel-Filled

FDA Pre-Market Approval

FDA Class 3 ·Natrelle Silicone-Filled Breast Implants

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

FDA Pre-Market Approval

FDA Class 3 ·QDOT MICRO CATHETER, nGEN RF Generator, TX eco Cable, TX eco EXT Cable

Device, Thermal Ablation, Endometrial

FDA Pre-Market Approval

FDA Class 3 ·NOVASURE IMPENDANCE CONTOLLED ENDOMETRIAL ABLATION SYSTEM

Computer-Assisted Personalized Sedation System

FDA Pre-Market Approval

FDA Class 3 ·SEDASYS COMPUTER-ASSISTED PERSONALIZED SEDATION SYSTEM