Aortic Stent

FDA Pre-Market Approval

FDA Class 3 ·Cheatham Platinum (CP) Stent System (Covered CP Stent, Covered Mounted CP Stent, CP Stent, Mounted CP Stent)

Sensor, Glucose, Invasive, Non-Adjunctive

FDA Pre-Market Approval

FDA Class 3 ·Simplera (TM) System

Aortic Stent

FDA Pre-Market Approval

FDA Class 3 ·Minima Stent System

Aortic Stent

FDA Pre-Market Approval

FDA Class 3 ·Minima Stent System

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

FDA Pre-Market Approval

FDA Class 3 ·INTELLANAV STABLEPOINT™ Ablation Catheter & Force Sensing System on the RHYTHMIA HDX™ Mapping System

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

FDA Pre-Market Approval

FDA Class 3 ·Blazer Open-Irrigated Ablation Catheter and IntellaNav Open-Irrigated Ablation Catheter

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

FDA Pre-Market Approval

FDA Class 3 ·QUADRA ASSURA/UNIFY ASSURA FAMILY PF CRT-DS

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

FDA Pre-Market Approval

FDA Class 3 ·POLARx/POLARx FIT Cryoablation Catheters, SMARTFREEZE Cryoablation Console, Accessories

Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Ceramic/Metal, Cemented Or Uncemented

FDA Pre-Market Approval

FDA Class 3 ·REFLECTION CERAMIC ACETABULAR SYSTEM

Separator For Therapeutic Purposes, Membrane Automated Blood Cell/Plasma

FDA Pre-Market Approval

FDA Class 3 ·GAMBRO AB PLASMAFILTER PF 2000N AND EXCORIM KB MAXO PLASMAFILTER

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

FDA Pre-Market Approval

FDA Class 3 ·Blazer Open-Irrigated and IntellaNav Open-Irrgated Ablation Catheters

Percutaneous Cardiac Ablation Catheter For Treatment Of Atrial Fibrillation With Irreversible Electroporation

FDA Pre-Market Approval

FDA Class 3 ·FARAPULSE™ Pulsed Field Ablation System (FARAWAVE™ Pulsed Field Ablation Catheter, FARASTAR™ Catheter Connection Cable,

Pump, Infusion, Implanted, Programmable

FDA Pre-Market Approval

FDA Class 3 ·INDURA 1 PIECE INTRATHECAL CATHETER WITH SUTURELESS CONNECTOR/INTRATHECAL CATHETER WITH SUTURELESS CONNECTOR

System, Balloon, Intra-Aortic And Control, Reprocessed

FDA classification

FDA Class 3 ·System, Balloon, Intra-Aortic And Control, Reprocessed