Pulse Generator, Permanent, Implantable

FDA Pre-Market Approval

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

Automated External Defibrillators (Non-Wearable)

FDA Pre-Market Approval

FDA Class 3 ·CPR Stat-Padz Electrode and CPR-D Padz Electrode

Automated External Defibrillators (Non-Wearable)

FDA Pre-Market Approval

FDA Class 3 ·Zoll OneStep CPR Cable, R Series OneStep Pacing Cable, X Series OneStep Cable, X Series/Propaq MD Multifunction Therapy

Automated External Defibrillators (Non-Wearable)

FDA Pre-Market Approval

FDA Class 3 ·CPR-D-padz One-Piece Electrode Pad with Real CPR Help, OneStep CPR Complete Electrode, Pro-padz Biphasic Electrode, Pro-

Automated External Defibrillators (Non-Wearable)

FDA Pre-Market Approval

FDA Class 3 ·CPR-D-padz electrode

Automated External Defibrillators (Non-Wearable)

FDA Pre-Market Approval

FDA Class 3 ·CPR-D-padz electrode

Automated External Defibrillators (Non-Wearable)

FDA Pre-Market Approval

FDA Class 3 ·CPR Uni-padz III

Automated External Defibrillators (Non-Wearable)

FDA Pre-Market Approval

FDA Class 3 ·ZOLL CPR Uni-padz

Automated External Defibrillators (Non-Wearable)

FDA Pre-Market Approval

FDA Class 3 ·ZOLL OneStep Pediatric CPR Electrode

APR METASUL ACETABULAR INSERT

FDA 510(k)

FDA Class 3 ·Orthopedic

Heart-Valve, Non-Allograft Tissue

FDA Pre-Market Approval

FDA Class 3 ·FREESTYLE AORTIC ROOT BIOPROSTHESIS

Implantable Pulse Generator, Pacemaker (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·RENEWAL/LIVIAN

Implantable Pulse Generator, Pacemaker (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·CONFIENT/VITALITY

Catheter, Percutaneous Transluminal Coronary Angioplasty (Ptca), Cutting/Scoring

FDA Pre-Market Approval

FDA Class 3 ·AngioSculpt® Evo RX PTCA Scoring Balloon Catheter with Hydrophilic Coating (AngioSculpt Evo catheter)

Automated External Defibrillators (Non-Wearable)

FDA Pre-Market Approval

FDA Class 3 ·Zoll R series OneStep CPR Cable, R Series Onestep Pacing Cable, R Series MFC (Multi-Function Cable), Multifunction Thera

Defibrillator, Implantable, Dual-Chamber

FDA Pre-Market Approval

FDA Class 3 ·Implantable Cardioverter Defibrillator ICDs

Automated External Defibrillators (Non-Wearable)

FDA Pre-Market Approval

FDA Class 3 ·ZOLL R Series Device

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

FDA Pre-Market Approval

FDA Class 3 ·Cardiac Resynchronization Therapy Defibrillator

Implantable Pacemaker Pulse-Generator

FDA Pre-Market Approval

FDA Class 3 ·Pulse Generator, Permanent Implantable DR-T/SR-T

MODIFIED ANATOMIC POROUS REPLACEMENT APR ACETABULA

FDA 510(k)

FDA Class 3 ·Orthopedic