Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·ENDOTAK RELIANCE EZ IS-1 AND 4-SITE EZ QUADRIPOLAR ACTIVE FIXATION LEADS

Cardiac Ablation Percutaneous Catheter

FDA Pre-Market Approval

FDA Class 3 ·CELSIUS,CELSIUS II, CELSIUS RMT, EZ STEER, EZ STEER DS DIAGNOSTIC/ABLATION CATHETERS

Cardiac Ablation Percutaneous Catheter

FDA Pre-Market Approval

FDA Class 3 ·CELSIUS THERMOCOOL/RMT//NAVISTAR/NAVISTAR RMT/EZ STEER/EZ STEER THERMOCOOL NAV CATHETERS

Cardiac Ablation Percutaneous Catheter

FDA Pre-Market Approval

FDA Class 3 ·CELSIUS/RMT/EZ STEER/EZ STEER DS/NON-TEMPERATURE SENSING ABLATION/INTERFACE CABLES

Lenses, Soft Contact, Extended Wear

FDA Pre-Market Approval

FDA Class 3 ·BIOMEDICS UV ASPHERE (OCUFILCON D) CONTACT LENSES FOR EXTENDED WEAR (UP TO 7 DAYS/6 NIGHTS OF EXTENDED WEAR)

Cardiac Ablation Percutaneous Catheter

FDA Pre-Market Approval

FDA Class 3 ·EZ Steer Non- Navigational 8mm (DS) ; EZ Steer DS ; EZ Steer Non-Navigational 4mm (TC) & (THR) ; Celsius 4mm Bi-Dir T ;

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

FDA Pre-Market Approval

FDA Class 3 ·ID/SN Label

Lens, Intraocular, Toric Optics

FDA Pre-Market Approval

FDA Class 3 ·enVista One-Piece Hydrophobic Acrylic Toric Intraocular Lens (Model MX60T)

Excimer Laser System

FDA Pre-Market Approval

FDA Class 3 ·TECHNOLAS TENEO™ 317 (MODEL 2) Excimer Laser System

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

FDA Pre-Market Approval

FDA Class 3 ·EZ Steer Thermocool Nav Bi-Directional Electrophysiology Catheter, EZ Steer Thermocool Bi-Directional Electrophysiology

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

FDA Pre-Market Approval

FDA Class 3 ·Celsius ThermoCool Electrophysiology Catheter, EZ Steer ThermoCool Bi-Directional Electrophysiology Catheter, EZ Steer T

Cardiac Ablation Percutaneous Catheter

FDA Pre-Market Approval

FDA Class 3 ·EZ STEER THERMOCOOL NAV CATHETER

Cardiac Ablation Percutaneous Catheter

FDA Pre-Market Approval

FDA Class 3 ·EZ STEER NAV ELECTROPHYSIOLOGY CATHETER

Cardiac Ablation Percutaneous Catheter

FDA Pre-Market Approval

FDA Class 3 ·NAVISTAR/EZ STEER NAV/QWIKSTAR

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

FDA Pre-Market Approval

FDA Class 3 ·FINELINE II STEROX EZ LEADS

Cardiac Ablation Percutaneous Catheter

FDA Pre-Market Approval

FDA Class 3 ·EZ STEER THERMOCOOL NAV CATHETER

Cardiac Ablation Percutaneous Catheter

FDA Pre-Market Approval

FDA Class 3 ·Celsius, Celsius Flutter, EZ Steer

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

FDA Pre-Market Approval

FDA Class 3 ·CELSIUS, NAVISTAR and EZ STEER

Lenses, Soft Contact, Extended Wear

FDA Pre-Market Approval

FDA Class 3 ·O2 OPTIX (LOTRAFILCON B) AND NIGHT AND DAY (LOTRAFILCON A) SOFT CONTACT LENSES FOR EXTENDED WEAR

Intraocular Lens

FDA Pre-Market Approval

FDA Class 3 ·Clareon Aspheric Hydrophobic Acrylic Intraocular Lens (IOL), Clareon Toric Aspheric Hydrophobic Acrylic Intraocular Lens