Prosthesis, Metatarsophalangeal Joint Cartilage Replacement Implant

FDA Pre-Market Approval

FDA Class 3 ·Cartiva SCI Implant

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

FDA Pre-Market Approval

FDA Class 3 ·Sentus QP leads

Prosthesis, Penis, Inflatable

FDA Pre-Market Approval

FDA Class 3 ·AMS 700 Series Product Line/Inflatable Penile Prosthesis (IPP) with and without InhibiZone Treatment

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

FDA Pre-Market Approval

FDA Class 3 ·Blazer OI, IntellaNav OI, IntellaTip MiFi OI

Implantable Pulse Generator, Pacemaker (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·REVO MRI IPG

Heart-Valve, Mechanical

FDA Pre-Market Approval

FDA Class 3 ·CARBOMEDICS PROSTHETIC HEART VALVE

Aortic Valve, Prosthesis, Percutaneously Delivered

FDA Pre-Market Approval

FDA Class 3 ·Edwards COmmander Delivery System

Stimulator, Spinal-Cord, Totally Implanted For Pain Relief

FDA Pre-Market Approval

FDA Class 3 ·PRECISION SPINAL CORD STIMULATOR (SCS) SYSTEM

Device, Hemostasis, Vascular

FDA Pre-Market Approval

FDA Class 3 ·STARCLOSE SE VASCULAR CLOSURE SYSTEM IFU

Kit, Dna Detection, Human Papillomavirus

FDA Pre-Market Approval

FDA Class 3 ·cobas HPV Test, 240/960 Tests

Stent, Urethral, Prostatic, Semi-Permanent

FDA Pre-Market Approval

FDA Class 3 ·SPANNER TEMPORARY PROSTATIC STENT WITH DISTAL CURVE DESIGN CHANGE

Cardiac Ablation Percutaneous Catheter

FDA Pre-Market Approval

FDA Class 3 ·MEDTRONIC ENHANCER ABLATION CATHETERS

Stent, Iliac

FDA Pre-Market Approval

FDA Class 3 ·SMART AND SMART CONTROL NITINOL STENT SYSTEM

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

FDA Pre-Market Approval

FDA Class 3 ·CAPSURE EPI PACING LEADS

Aid, Surgical, Viscoelastic

FDA Pre-Market Approval

FDA Class 3 ·BVI 1%OVD

Defibrillator, Automatic Implantable Cardioverter, With Cardiac Resynchronization (Crt-D)

FDA Pre-Market Approval

FDA Class 3 ·Fourier-Transform Infrared Spectroscopy (FTIR)

Prosthesis, Penis, Inflatable

FDA Pre-Market Approval

FDA Class 3 ·AMS 700™ Inflatable Penile Prosthesis (IPP) with and without InhibiZone™

Pulse Generator, Permanent, Implantable

FDA Pre-Market Approval

FDA Class 3 ·ADVISA DR IPG, ADVISA DR MRI IPG

Prosthesis, Testicular

FDA Pre-Market Approval

FDA Class 3 ·COLOPLAST SALINE-FILLED TESTICULAR PROSTHESIS

Stimulator, Electrical, Implantable, For Incontinence

FDA Pre-Market Approval

FDA Class 3 ·InterStim® Therapy System, Verify ® Evaluation System