Implanted Phrenic Nerve Stimulator For Central Sleep Apnea

FDA Pre-Market Approval

FDA Class 3 ·remede® System

Computer-Assisted Personalized Sedation System

FDA Pre-Market Approval

FDA Class 3 ·SEDASYS COMPUTER-ASSISTED PERSONALIZED SEDATION SYSTEM

Lymph Node Location System During Sentinel Biopsy Procedure

FDA Pre-Market Approval

FDA Class 3 ·Magtrace® and Sentimag® Magnetic Locatization System (PUV)

Lymph Node Location System During Sentinel Biopsy Procedure

FDA Pre-Market Approval

FDA Class 3 ·Magtrace and Sentimag Magnetic Locatization System (PUV)

Implanted Phrenic Nerve Stimulator For Central Sleep Apnea

FDA Pre-Market Approval

FDA Class 3 ·remede® System

Computer-Assisted Personalized Sedation System

FDA Pre-Market Approval

FDA Class 3 ·SEDASYS COMPUTER-ASSISTED PERSONALIZED SEDATION SYSTEM

Intraocular Lens

FDA Pre-Market Approval

FDA Class 3 ·PreVue Pre-loaded System, IPURE Pre-loaded System

Intraocular Lens

FDA Pre-Market Approval

FDA Class 3 ·iSert Preloaded IOL System, IPure™ Preloaded IOL System

Intraocular Lens

FDA Pre-Market Approval

FDA Class 3 ·iSert Preloaded, Clarisert and IPURE AF-1 Intraocular Lenses

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·NG3 Implantable Cardioverter Defibrillators - Origen, Inogen, Dynagen, Autogen / NG4 - Momentum, Vigilant, Resonate, Per

Intraocular Lens

FDA Pre-Market Approval

FDA Class 3 ·iSert® Pre-loaded System; IPURE Pre-loaded System; PreVue Pre-loaded System

Drug-Eluting Peripheral Transluminal Angioplasty Catheter

FDA Pre-Market Approval

FDA Class 3 ·IN.PACT Admiral Paclitaxel-Coated Percutaneous Transluminal Angioplasty (PTA) Balloon, IN.PACT 018 Paclitaxel-Coated Per

Replacement Heart-Valve

FDA Pre-Market Approval

FDA Class 3 ·Carpentier-Edwards PERIMOUNT/PERIMOUNT RSR/Magna Pericardial Aortic Bioprosthesis; Carpentir-Edwards PERIMOUNT Theon/PER

Laser, Neodymium:Yag, Ophthalmic For Uses Other Than Posterior Capsulotomy & Cutting Pupillary

FDA Pre-Market Approval

FDA Class 3 ·HORIZON(TM) YAG LASER MODEL 2000

Laser, Neodymium:Yag, Ophthalmic For Uses Other Than Posterior Capsulotomy & Cutting Pupillary

FDA Pre-Market Approval

FDA Class 3 ·HORIZON(TM) YAG LASER MODEL 2000

Laser, Neodymium:Yag, Ophthalmic For Uses Other Than Posterior Capsulotomy & Cutting Pupillary

FDA Pre-Market Approval

FDA Class 3 ·HORIZON(TM) YAG LASER MODEL 2000

Laser, Neodymium:Yag, Ophthalmic For Uses Other Than Posterior Capsulotomy & Cutting Pupillary

FDA Pre-Market Approval

FDA Class 3 ·HORIZON(TM) YAG LASER MODEL 2000

Laser, Neodymium:Yag, Ophthalmic For Uses Other Than Posterior Capsulotomy & Cutting Pupillary

FDA Pre-Market Approval

FDA Class 3 ·HORIZON(TM) YAG LASER MODEL 2000

Laser, Neodymium:Yag, Ophthalmic For Uses Other Than Posterior Capsulotomy & Cutting Pupillary

FDA Pre-Market Approval

FDA Class 3 ·HORIZON(TM) YAG LASER MODEL 2000

Laser, Neodymium:Yag, Ophthalmic For Uses Other Than Posterior Capsulotomy & Cutting Pupillary

FDA Pre-Market Approval

FDA Class 3 ·HORIZON(TM) YAG LASER MODEL 2000