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