Kit, Test, Alpha-Fetoprotein For Neural Tube Defects

FDA Pre-Market Approval

FDA Class 3 ·AFP RIA KIT

Coronary Drug-Eluting Stent

FDA Pre-Market Approval

FDA Class 3 ·Orsiro Mission Sirolimus Eluting Coronary Stent System

Permanent Defibrillator Electrodes

FDA Pre-Market Approval

FDA Class 3 ·Ultrasonic Cleaning Machine

Aortic Valve, Prosthesis, Percutaneously Delivered

FDA Pre-Market Approval

FDA Class 3 ·Core Valve Evolut R System and Core Valve Evolut PRO System

Leadless Pacemaker

FDA Pre-Market Approval

FDA Class 3 ·Micra AV Transcatheter Pacemaker System

Ventilator, High Frequency

FDA Pre-Market Approval

FDA Class 3 ·LifePulse High Frequency Ventilator

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

FDA Pre-Market Approval

FDA Class 3 ·LCS Total Knee System

Pulse Generator, Permanent, Implantable

FDA Pre-Market Approval

FDA Class 3 ·Adapta, Versa, Sensia IPG, Advisa DR IPG, Advisa DR/SR MRI IPG, Astra S DR/SR MRI IPG, Astra XT DR/SR MRI IPG, Azure S D

Implantable Pulse Generator, Pacemaker (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·Percepta Bipolar CRT-P, Percepta Quadripolar CRT-P, Serena Bipolar CRT-P, Serena Quadripolar CRT-P, Solara Bipolar CRT-P

Permanent Defibrillator Electrodes

FDA Pre-Market Approval

FDA Class 3 ·HV Splitter/Adaptor kit, Sprint Quattro Lead

Defibrillator, Implantable, Dual-Chamber

FDA Pre-Market Approval

FDA Class 3 ·Ilivia Neo 7 DR-T

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

FDA Pre-Market Approval

FDA Class 3 ·CapSureFix Novus Lead

Implantable Pulse Generator, Pacemaker (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·INSYNC CRT-P & INSYNC III CRT-P

Stimulator, Electrical, Implanted, For Parkinsonian Tremor

FDA Pre-Market Approval

FDA Class 3 ·ACTIVA DEEP BRAIN STIMULATION THERAPY SYSTEM

Fluid, Hysteroscopy

FDA Pre-Market Approval

FDA Class 3 ·DEXTRAN HM 32%

Applicator, Hyperthermia, Interstitial

FDA Pre-Market Approval

FDA Class 3 ·VOL. HYPERTHERMIA TREATMENT SYSTEM MODEL VH8500

Pulse Generator, Permanent, Implantable

FDA Pre-Market Approval

FDA Class 3 ·LEGEND PLUS FAMILY OF PACEMAKERS

Defibrillator, Implantable, Dual-Chamber

FDA Pre-Market Approval

FDA Class 3 ·TACHOS DR IMPLANTALBLE CARDIOVERTER DEFIBRILLATOR (ICD) SYSTEM

Barrier, Absorbable, Adhesion

FDA Pre-Market Approval

FDA Class 3 ·INTERCEED ABSORBABLE ADHESION BARRIER

Lenses, Soft Contact, Extended Wear

FDA Pre-Market Approval

FDA Class 3 ·PERMLENS