2,490 results · 24ms · Sources: EU EUDAMED, US FDA

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

FDA Pre-Market Approval
FDA Class 3 ·QUADRIPOLAR PACING PAS (QUAD PAS)

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

FDA Pre-Market Approval
FDA Class 3 ·MT PAS ACUITY X4

Heart-Valve, Non-Allograft Tissue

FDA Pre-Market Approval
FDA Class 3 ·Inspiris Resilia Aortic Valve

Implant, Cochlear

FDA Pre-Market Approval
FDA Class 3 ·Nucleus 24 Cochlear Implant System

Intraocular Pressure Lowering Implant

FDA Pre-Market Approval
FDA Class 3 ·Hydrus Microstent

Heart-Valve, Non-Allograft Tissue

FDA Pre-Market Approval
FDA Class 3 ·INSPIRIS RESILIA Aortic Valve, Model 11500A

Stent, Coronary

FDA Pre-Market Approval
FDA Class 3 ·NIRXCELL PMS US STUDY NIRTRAKS

Prosthesis, Intervertebral Disc

FDA Pre-Market Approval
FDA Class 3 ·Simplify® Cervical Artificial Disc (One-Level)

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval
FDA Class 3 ·RESONATE™ HF, RESONATE™ EL, MOMENTUM™ EL, VIGILIANT™ EL, PERCIVA™ HF, PERCIVA™

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

FDA Pre-Market Approval
FDA Class 3 ·RESONATE™ HF, RESONATE™, RESONATE™ X4, MOMENTUM™, MOMENTUM™ X4, VIGILIANT™, VIGILIANT™ X4

Stent, Superficial Femoral Artery

FDA Pre-Market Approval
FDA Class 3 ·Astron Pulsar/Pulsar-18 Stent System

Intraocular Pressure Lowering Implant

FDA Pre-Market Approval
FDA Class 3 ·Hydrus Microsent

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

FDA Pre-Market Approval
FDA Class 3 ·Biosense Webster NaviStar ThermoCool Catheter

Catheter, Percutaneous Transluminal Coronary Angioplasty (Ptca), Cutting/Scoring

FDA Pre-Market Approval
FDA Class 3 ·Lacrosse NSE ALPHA Coronary Dilatation Catheter

Implanted Brain Stimulator For Epilepsy

FDA Pre-Market Approval
FDA Class 3 ·NeuroPace RNS System

Occluder, Patent Ductus, Arteriosus

FDA Pre-Market Approval
FDA Class 3 ·NIT-OCCLUD PDA

Extended Depth Of Focus Intraocular Lens

FDA Pre-Market Approval
FDA Class 3 ·IC-8 Apthera Intraocular Lens (IOL)

Filler, Bone Void, Synthetic Peptide

FDA Pre-Market Approval
FDA Class 3 ·i-FACTOR Peptide Enhanced Bone Graft

Coronary Drug-Eluting Stent

FDA Pre-Market Approval
FDA Class 3 ·SYNERGY XD Everolimus Eluting Platinum Chromium Coronary Stent System and SYNERGY SHIELD Everolimus Eluting Platinum Chr

Implant, Dermal, For Aesthetic Use

FDA Pre-Market Approval
FDA Class 3 ·SCULPTRA AESTHETIC (INJECTABLE POLY-L-LACTIC ACID)