Cardiac Ablation Percutaneous Catheter

FDA Pre-Market Approval

FDA Class 3 ·Therapy™ Ablation Catheter (4mm and 8mm), Cables 16- 17- 18- & 19-

Test, Hepatitis B (B Core, Be Antigen, Be Antibody, B Core Igm)

FDA Pre-Market Approval

FDA Class 3 ·ETI-MAK-2 PLUS ASSAY

Test, Hepatitis B (B Core, Be Antigen, Be Antibody, B Core Igm)

FDA Pre-Market Approval

FDA Class 3 ·DiaSorin ETI-EBK PLUS assay

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

FDA Pre-Market Approval

FDA Class 3 ·THERAPY DUAL 8/THERAPY 8MM THERMISTOR/SAFIRE TX ABLATION CATHETERS

Lens, Intraocular, Phakic

FDA Pre-Market Approval

FDA Class 3 ·STAAR SURGICAL IMPLANTABLE COLLAMER LENSES FOR MYOPIA

Lens, Intraocular, Phakic

FDA Pre-Market Approval

FDA Class 3 ·Visian Toric ICL (Implantable Collamer Lens)

Test, Hepatitis B (B Core, Be Antigen, Be Antibody, B Core Igm)

FDA Pre-Market Approval

FDA Class 3 ·ETI-MAK-2 PLUS and HBsAg Confirmatory Test assays

Intraocular Lens

FDA Pre-Market Approval

FDA Class 3 ·STAAR SURGICAL COLLAMER INTRAOCULAR LENSES

Lens, Intraocular, Phakic

FDA Pre-Market Approval

FDA Class 3 ·STAAR SURGICAL IMPLANTABLE COLLAMER LENS FOR MYOPIA

Intraocular Lens

FDA Pre-Market Approval

FDA Class 3 ·CHOYCE MARK VIII ANTERIOR CHAMBER INTEROCULAR LENS

Implantable Pulse Generator, Pacemaker (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·PULSAR/PULSAR MAX IMPLANTABLE PULSE GENERATOR SYSTEM WITH CONSULT SOFTWARE

Implanted Brain Stimulator For Epilepsy

FDA Pre-Market Approval

FDA Class 3 ·NEUROPACE RNS SYSTEM

Replacement Heart-Valve

FDA Pre-Market Approval

FDA Class 3 ·Mosaic Porcine Bioprosthesis

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

FDA Pre-Market Approval

FDA Class 3 ·CONTAK CD 2 MODEL H115

Heart-Valve, Non-Allograft Tissue

FDA Pre-Market Approval

FDA Class 3 ·FREESTYLE AORTIC ROOT BIOPROSTHESIS

Implantable Pulse Generator, Pacemaker (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·CONTAK CD, EASYTRAK, LIVIAN, COGNIS, AND ACUITY SPIRAL, ENERGEN CRT-D, PUNCTUA CRT-D, INCEPTA CRT-D

Implantable Pulse Generator, Pacemaker (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·INGENIO 2 PACEMAKERS. ALTRUA 2 , ESSENTIO, PROPONENT, ACCOLADE. IMPLANTABLE PULSE GENERATOR (PG), ADVANTIO, INGENIO, VI

Intraocular Lens

FDA Pre-Market Approval

FDA Class 3 ·Lenstec Softec HD aspheric posterior chamber intraocular lens

Replacement Heart-Valve

FDA Pre-Market Approval

FDA Class 3 ·Hancock II Bioprosthesis

Implanted Brain Stimulator For Epilepsy

FDA Pre-Market Approval

FDA Class 3 ·NeuroPace RNS System