8,847 results · 41ms · Sources: EU EUDAMED, US FDA

Stimulator, Spinal-Cord, Totally Implanted For Pain Relief

FDA Pre-Market Approval
FDA Class 3 ·Proclaim Family of Implantable Pulse Generators

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

FDA Pre-Market Approval
FDA Class 3 ·VITROS Immunodiagnostic Products HBsAg Reagent Pack, Calibrator and Confirmatory Kit

Mitral Valve Repair Devices

FDA Pre-Market Approval
FDA Class 3 ·MitraClip™ G4 Clip Delivery System

Stent Graft, Infrapopliteal, Venous Arterialization

FDA Pre-Market Approval
FDA Class 3 ·LimFlow System

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

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

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

FDA Pre-Market Approval
FDA Class 3 ·ELECSYS HBSAG IMMUNOASSAY & CONFIRMATORY & PRECICONTROL HBSAG

Reherniation Reduction Device

FDA Pre-Market Approval
FDA Class 3 ·Barricaid Anular Closure Device

Intraocular Lens

FDA Pre-Market Approval
FDA Class 3 ·TECNIS Multifocal Toric II Intraocular Lenses

Implant, Anti-Gastroesophageal Reflux

FDA Pre-Market Approval
FDA Class 3 ·LINX REFLUX MANAGEMENT SYSTEM

Aid, Surgical, Viscoelastic

FDA Pre-Market Approval
FDA Class 3 ·Amvisc and Amvisc Plus Ophthalmic Viscosurgical Device (OVD)

Implant, Cochlear

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

Aortic Valve, Prosthesis, Percutaneously Delivered

FDA Pre-Market Approval
FDA Class 3 ·EDWARDS SAPIEN TRANSCATHETER HEART VALVE

System, Hyperthermia, Rf/Microwave (Benign Prostatic Hyperplasia),Thermotherapy

FDA Pre-Market Approval
FDA Class 3 ·UROLOGIX TARGIS SYSTEM

Permanent Defibrillator Electrodes

FDA Pre-Market Approval
FDA Class 3 ·SJM ISOFLEX OPTIM LEADS

Total, Prostate Specific Antigen (Noncomplexed & Complexed) For Detection Of Prostate Cancer

FDA Pre-Market Approval
FDA Class 3 ·ADVIA CENTAUR PSA ASSAY

Coronary Drug-Eluting Stent

FDA Pre-Market Approval
FDA Class 3 ·CORDIS CYPHER SIROLIMUS-ELUTING CORONARY STENT

Assay, Hybridization And/Or Nucleic Acid Amplification For Detection Of Hepatitis C Rna,Hepatitis C Virus

FDA Pre-Market Approval
FDA Class 2 ·COBAS AMPLICOR HCV TEST, V2.0

Prosthesis, Intervertebral Disc

FDA Pre-Market Approval
FDA Class 3 ·PRODISC-C TOTAL DISC REPLACEMENT

System, Hyperthermia, Rf/Microwave (Benign Prostatic Hyperplasia),Thermotherapy

FDA Pre-Market Approval
FDA Class 3 ·THERMATRX TMX-2000 BPH THERMOTHERAPY SYSTEM

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

FDA Pre-Market Approval
FDA Class 3 ·ANTHOLOGY FEMORAL STEMS