10,000 results · 44ms · Sources: EU EUDAMED, US FDA

Temporary Non-Roller Type Right Heart Support Blood Pump

FDA Pre-Market Approval
FDA Class 3 ·Impella RP System

Implantable Pulse Generator, Pacemaker (Non-Crt)

FDA Pre-Market Approval
FDA Class 3 ·MULTICETER AUTOMATIC DEFIBRILLATOR IMPLANT ATION YTRIAL WITH CARDIAC RESYNCHRONIZATION THERAPY

Coronary Drug-Eluting Stent

FDA Pre-Market Approval
FDA Class 3 ·RESOLUTE INTEGRITY ZOTAROLIMUS-ELUTING CORONARY STENT SYSTEMS

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

FDA Pre-Market Approval
FDA Class 3 ·LCS Total Knee System

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

FDA Pre-Market Approval
FDA Class 3 ·CONCERTO/INSYNC SENTRY/INSYNC MAXIMO IMPLANTABLE CARDIOVASCULAR DEFIBRILLATORS

Pulse Generator, Permanent, Implantable

FDA Pre-Market Approval
FDA Class 3 ·Azure and Astra MRI SureScan IPG and Pacing System

Prosthesis, Breast, Noninflatable, Internal, Silicone Gel-Filled

FDA Pre-Market Approval
FDA Class 3 ·NATRELLE SILICONE GEL-FILLED BREAST IMPLANTS

Transcervical Contraceptive Tubal Occlusion Device

FDA Pre-Market Approval
FDA Class 3 ·ESSURE SYSTEM

Normothermic Machine Perfusion System For The Preservation Of Donor Livers Prior To Transplantation

FDA Pre-Market Approval
FDA Class 3 ·Organ Care System (OCS®) Liver™

Prosthesis, Intervertebral Disc

FDA Pre-Market Approval
FDA Class 3 ·Mobi-C Cervical Disc Prosthesis (one-level indications)

Implanted Electrical Device Intended For Treatment Of Fecal Incontinence

FDA Pre-Market Approval
FDA Class 3 ·INTERSTIM SACRAL NERVE STIMULATION THERAPY FOR BOWEL CONTROL

Neuromodulator For Obesity

FDA Pre-Market Approval
FDA Class 3 ·MAESTRO RECHARGEABLE SYSTEM

Coronary Drug-Eluting Stent

FDA Pre-Market Approval
FDA Class 3 ·CYPHER SIROLIMUS-ELUTING CORONARY STENT ON RAPTOR OTW DELIVERY SYSTEM/RAPTORRAIL RAPID EXCHANGE DELIVERY SYSTEM

Laparoscopic Contraceptive Tubal Occlusion Device

FDA Pre-Market Approval
FDA Class 3 ·Filshie Clip System

Stimulator, Tibial, Electrical, Implantable, For Urinary Incontinence

FDA Pre-Market Approval
FDA Class 3 ·eCoin Peripheral Neurostimulator

Cardiac Ablation Percutaneous Catheter

FDA Pre-Market Approval
FDA Class 3 ·7F FREEZOR CARDIAC CYROABLATION CATHETER AND CCT.2 CRYOCONSOLE SYSTEM

Stimulator, Ultrasound And Muscle, For Use Other Than Applying Therapeutic Deep

FDA Pre-Market Approval
FDA Class 3 ·EXOGEN BONE HEALING SYSTEM

Agent, Absorbable Hemostatic, Non-Collagen Based

FDA Pre-Market Approval
FDA Class 3 ·ARISTA AH ABSORBABLE HEMOSTAT

Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Ceramic/Metal, Cemented Or Uncemented

FDA Pre-Market Approval
FDA Class 3 ·REFLECTION CERAMIC ACETABULAR HIP SYSTEM (RCHS)

Lens, Multifocal Intraocular

FDA Pre-Market Approval
FDA Class 3 ·TECNIS MULTIFOCAL FOLDABLE ACRYLIC INTRAOCULAR LENS