Lens, Multifocal Intraocular

FDA Pre-Market Approval

FDA Class 3 ·ACRYSOF RESTOR INTRAOCULAR LENSES

Lens, Intraocular, Phakic

FDA Pre-Market Approval

FDA Class 3 ·VISIAN IMPLANTABLE COLLAMER LENS FOR MYOPIA (MICL)

Intraocular Lens

FDA Pre-Market Approval

FDA Class 3 ·Clareon Intraocular Lenses with the AutonoMe Delivery System

Intraocular Lens

FDA Pre-Market Approval

FDA Class 3 ·C-FLEX ASPHERIC INTRAOCULAR LENS MODEL 970C

Pulse Generator, Permanent, Implantable

FDA Pre-Market Approval

FDA Class 3 ·MY CARELINK PATIENT MONITOR MODEL 24950

Drug-Eluting Sinus Stent

FDA Pre-Market Approval

FDA Class 3 ·PROPEL, PROPEL MINI and PROPEL CONTOUR

Pulse Generator, Permanent, Implantable

FDA Pre-Market Approval

FDA Class 3 ·MEDTRONIC MODEL 25000 MY CARELINK SMART READER

Pulse Generator, Permanent, Implantable

FDA Pre-Market Approval

FDA Class 3 ·MY CARE-LINK SMART MONITOR PATIENT READER

Drug-Eluting Sinus Stent

FDA Pre-Market Approval

FDA Class 3 ·Mometasone Furoate Container Closure System

Pump, Infusion, Implanted, Programmable

FDA Pre-Market Approval

FDA Class 3 ·SynchroMed II Motor Gear Train Shafts

Pulse Generator, Permanent, Implantable

FDA Pre-Market Approval

FDA Class 3 ·CareLink Express Monitor, Monitor CardioSight Reader, My CareLink Patient Monitor.

Drug-Eluting Sinus Stent

FDA Pre-Market Approval

FDA Class 3 ·Propel Contour Sinus Implant

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

FDA Pre-Market Approval

FDA Class 3 ·PARADYM VR 8250, PARADYM DR 8550, PARADYM CRT-D 8750, PARADYM RF VR 9250, PARADYM RF DR 9550, PARADYM M RF CRT-D 9750

Stent, Coronary

FDA classification

FDA Class 3 ·Stent, Coronary

Stent, Coronary

FDA Pre-Market Approval

FDA Class 3 ·MAGIC WALLSTENT EDNDOPROSTHESIS AND RADIUS CORONARY STENT WITH DELIVERY SYSTEM

Total, Prostate Specific Antigen (Noncomplexed & Complexed) For Detection Of Prostate Cancer

FDA Pre-Market Approval

FDA Class 3 ·VIDAS TOTAL PSA

Stent, Coronary

FDA Pre-Market Approval

FDA Class 3 ·DRIVER AND MICRO-DRIVER CORONARY STENT SYSTEMS

Stent, Coronary

FDA Pre-Market Approval

FDA Class 3 ·ZETA RX/ULTRA RX/OTW

System, Laser, Photodynamic Therapy

FDA Pre-Market Approval

FDA Class 3 ·COHERENT OPAL PHOTOACTIVATOR

Stent, Coronary

FDA Pre-Market Approval

FDA Class 3 ·MULTI-LINK 8 CORONARY STENT SYSTEM