Lens, Multifocal Intraocular

FDA Pre-Market Approval

FDA Class 3 ·AcrySof IQ ReSTOR Posterior Chamber Intraocular Lenses

Intraocular Lens

FDA Pre-Market Approval

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

Intraocular Lens

FDA Pre-Market Approval

FDA Class 3 ·AcrySof Posterior Chamber Intraocular Lens and Delivery Systems

Intracranial Aneurysm Flow Diverter

FDA Pre-Market Approval

FDA Class 3 ·PIPELINE EMBOLIZATION DEVICE

Sensor, Glucose, Invasive

FDA Pre-Market Approval

FDA Class 3 ·DEV-0016 CARELINK PERSONAL SOFTWARE VERSION 1.0A

Aid, Surgical, Viscoelastic

FDA Pre-Market Approval

FDA Class 3 ·VISCOAT OPHTHALMIC VISCOSURGICAL DEVICES; DUOVISC OPTHALMIC VISCOSURGICAL DEVICES; DISCOVISC OPTHALMIC VISCOSURGICAL DEV

FIRST MEDIC MODE 610

FDA 510(k)

FDA Class 3 ·Cardiovascular

HEARTSTART 2000

FDA 510(k)

FDA Class 3 ·Cardiovascular

Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Metal/Polymer, Mobile Bearing

FDA Pre-Market Approval

FDA Class 3 ·NEW JERSEY LCS(R) TOTAL KNEE SYSTEM-ADDITION OF THREE PEGGED PATTELLA PROSTHESES

Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Metal/Polymer, Mobile Bearing

FDA Pre-Market Approval

FDA Class 3 ·NEW JERSEY LCS(R) TOTAL KNEE SYSTEM-ADDITION OF THREE PEGGED PATTELLA PROSTHESES

Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Metal/Polymer, Mobile Bearing

FDA Pre-Market Approval

FDA Class 3 ·NEW JERSEY LCS(R) TOTAL KNEE SYSTEM-ADDITION OF THREE PEGGED PATTELLA PROSTHESES

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·TELIGEN, ENERGEN, PUNCTUA, INCEPTA, ORIGEN, INOGEN, DYNAGEN, AUTOGEN, RESONATE, MOMENTUM, VIGILANT, and PERCIVA (ICD Dev

Pulse Generator, Permanent, Implantable

FDA Pre-Market Approval

FDA Class 3 ·CARELINK ENORE PROGRAMMER,CARELINK 2090 PROGRAMMER,CARELINK HOME MONITOR,CARELINK EXPRESS MONITOR,CARDIOSIGHT READER,DEV

System, Endovascular Graft, Arteriovenous (Av) Dialysis Access Circuit Stenosis Treatment

FDA Pre-Market Approval

FDA Class 3 ·GORE® VIABAHN® Endoprosthesis, GORE® VIABAHN® Endoprosthesis with Heparin Bioactive Surface

Lymph Node Location System During Sentinel Biopsy Procedure

FDA Pre-Market Approval

FDA Class 3 ·Magtrace/and Sentimag Magnetic Localization System

System, Endovascular Graft, Arteriovenous (Av) Dialysis Access Circuit Stenosis Treatment

FDA Pre-Market Approval

FDA Class 3 ·Fluency® Plus Endovascular Stent Graft

System, Endovascular Graft, Arteriovenous (Av) Dialysis Access Circuit Stenosis Treatment

FDA Pre-Market Approval

FDA Class 3 ·FLAIR ENDOVASCULAR STENT GRAFT

System, Endovascular Graft, Arteriovenous (Av) Dialysis Access Circuit Stenosis Treatment

FDA Pre-Market Approval

FDA Class 3 ·BARD FLAIR ENDOVASCULAR STENT GRAFT

Lymph Node Location System During Sentinel Biopsy Procedure

FDA Pre-Market Approval

FDA Class 3 ·Magtrace and Sentimag Magnetic Localization System

System, Endovascular Graft, Arteriovenous (Av) Dialysis Access Circuit Stenosis Treatment

FDA Pre-Market Approval

FDA Class 3 ·Fluency™ Endovascular Stent Graft