System, Laser, Photodynamic Therapy

FDA Pre-Market Approval

FDA Class 3 ·QCELLUS LASER

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

FDA Pre-Market Approval

FDA Class 3 ·Avant HF CRT-D, Neutrino NxT HF CRT-D, Gallant HF CRT-D, and Entrant HF CRT-D

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·Avant VR ICD, Avant DR ICD, Neutrino NxT VR ICD, Neutrino NxT DR ICD, Gallant VR ICD, Gallant DR ICD, Entrant VR ICD and

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

FDA Pre-Market Approval

FDA Class 3 ·ISOFLEX FAMILY OF LEADS (1944,1948)

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

FDA Pre-Market Approval

FDA Class 3 ·TENDRIL AND OPTISENSE FAMILY OF LEADS

OSCOR MEDICAL UNIPOLAR PERMANENT PACING LEAD-CONNE

FDA 510(k)

FDA Class 3 ·Cardiovascular

MODIFIED OSCOR PY PACING LEADS

FDA 510(k)

FDA Class 3 ·Cardiovascular

OSCOR MEDICAL FIX SCREW PACING LEAD/PEELABLE CATH

FDA 510(k)

FDA Class 3 ·Cardiovascular

MODEL PY...U UNIPOLAR & BIPOLAR PACING LEAD

FDA 510(k)

FDA Class 3 ·Cardiovascular

3.2MM UNIPOLAR & BIPOLAR LEAD CONNECTORS (VS-1)

FDA 510(k)

FDA Class 3 ·Cardiovascular

Coronary Drug-Eluting Stent

FDA Pre-Market Approval

FDA Class 3 ·PROMUS ELEMENT PLUS & PROMUS PREMIER EVEROLINUS-ELTING PLATINUM CHROMINUM CORONARY STENT SYSTEM

Scaffold, Dissection Repair

FDA Pre-Market Approval

FDA Class 3 ·Tack Endovascular System (6F)

Artificial Iris

FDA Pre-Market Approval

FDA Class 3 ·CustomFlex Artificial Iris

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

Artificial Iris

FDA Pre-Market Approval

FDA Class 3 ·CustomFlex ArtificialIris

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

Scaffold, Dissection Repair

FDA Pre-Market Approval

FDA Class 3 ·Tack Endovascular System

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

Daily Wear Soft Contact Lens To Reduce The Progression Of Myopia

FDA Pre-Market Approval

FDA Class 3 ·MiSight 1 Day (omafilcon A)

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