Prosthesis, Ankle, Uncemented, Non-Constrained

FDA Pre-Market Approval

FDA Class 3 ·SCANDINAVIAN TOTAL ANKLE REPLACEMENT SYSTEM (STAR ANKLE)

Intraocular Lens

FDA Pre-Market Approval

FDA Class 3 ·HQL Softec HD, Softec I, Softec HD PS, Softec HDO, Softec HDM

Daily Wear Soft Contact Lens To Reduce The Progression Of Myopia

FDA Pre-Market Approval

FDA Class 3 ·MiSight 1 Day (omafilcon A) Soft (Hydrophilic) Contact Lenses for Daily Wear

Intraocular Lens

FDA Pre-Market Approval

FDA Class 3 ·Softec HD, Softec I, Softec HD PS, Softec HDO, and Softec HDM IOLs

Intraocular Lens

FDA Pre-Market Approval

FDA Class 3 ·Softec HD, Softec I, Softec HD PS, Softec HDO, and Softec HDM IOLs

Intraocular Lens

FDA Pre-Market Approval

FDA Class 3 ·Softec HD, Softec I, Softec HD PS, Softec HDO, and Softec HDM IOLs

Intraocular Lens

FDA Pre-Market Approval

FDA Class 3 ·SOFTEE HD POSTERIOR CHAMBER INTRAOCULAR LENS (PCIOL)

Pulse Generator, Permanent, Implantable

FDA Pre-Market Approval

FDA Class 3 ·2490G/H/J CARELINK MONITOR, 2020A CARDIOSIGHT READER

DJO SURGICAL REVISION FEMORAL HIP SYSTEM, MODEL 428-14/24-140/200; 428-00-050/110;

FDA 510(k)

FDA Class 3 ·Orthopedic

Pulse Generator, Permanent, Implantable

FDA Pre-Market Approval

FDA Class 3 ·MEDTRONIC CARELINK EXPRESS MONITORS, MODIFICATIONS T THE MEDTRONIC CARELINK REMOTE HOME MONITOR AND MEDTRONIC CARDIOSIGH

Pulse Generator, Permanent, Implantable

FDA Pre-Market Approval

FDA Class 3 ·MODEL 2490C/G/H/J CARELINK REMOTE HOME MONITOR/2020A ANALYZER

Pulse Generator, Permanent, Implantable

FDA Pre-Market Approval

FDA Class 3 ·MEDTRONIC 2490 A/C/D/E/G/H/J CARELINK MONITORS

Intraocular Lens

FDA Pre-Market Approval

FDA Class 3 ·SOFTEC HD POSTERIOR CHAMBER INTRAOCULAR LENS (PCIOL)

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·MODEL 2490G/H/J MEDTRONIC CARELINK MONITOR AND THE MODEL 2020A CARDIOSIGHT READER

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·MEDTRONIC IMPLANTABLE CARDIOVERTER DEFIBRILLATOR SYSTEMS

Pulse Generator, Permanent, Implantable

FDA Pre-Market Approval

FDA Class 3 ·MEDTRONIC PACEMAKER SYSTEMS

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·MEDTRONIC IMPLANTABLE CARDIOVERTER DEFIBRILLATOR SYSTEMS

Pulse Generator, Permanent, Implantable

FDA Pre-Market Approval

FDA Class 3 ·MEDTRONIC PACEMAKER SYSTEMS

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

FDA Pre-Market Approval

FDA Class 3 ·MEDTRONIC CARDIAC RESYNCHRONIZATION THERAPY-DEFIBRILLATOR SYSTEMS

Analyzer, Data, Obstetric

FDA Pre-Market Approval

FDA Class 3 ·STAN S31 FETAL HEART MONITOR