10,000 results
·
58ms
·
Sources: EU EUDAMED, US FDA
Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Ceramic/Metal, Cemented Or Uncemented
FDA Pre-Market Approval
FDA Class 3
·R3 Delta Ceramic Acetabular System
Placental Alpha Microglobulin-1 Immunoassay
FDA Pre-Market Approval
FDA Class 3
·PartoSure Test
Test, Hepatitis B (B Core, Be Antigen, Be Antibody, B Core Igm)
FDA Pre-Market Approval
FDA Class 3
·VITROS Immunodiagnostic Products HBeAg Reagent Pack and Calibrator
Lipoprotein, Low Density, Removal
FDA Pre-Market Approval
FDA Class 3
·LIPOSORBER® LA-15 System
System, Endovascular Graft, Aortic Aneurysm Treatment
FDA Pre-Market Approval
FDA Class 3
·AFX ENDOVASCULAR AAA SYSTEM
Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Flutter
FDA Pre-Market Approval
FDA Class 3
·BLAZER II XP, BLAZER PRIME XP & BLAZER XP RPM CARDIAC ABLATION CATHETERS & STERILE CABLES
Transcatheter Septal Occluder
FDA Pre-Market Approval
FDA Class 3
·Gore CardioForm Septal Occluder
Processor, Cervical Cytology Slide, Automated
FDA Pre-Market Approval
FDA Class 3
·BD PrepMate
Pulse Generator, Pacemaker, Implantable, With Cardiac Resynchronization (Crt-P)
FDA Pre-Market Approval
FDA Class 3
·FRONTIER AND FRONTIER II FAMILIES OF PACEMAKERS
Drug Eluting Permanent Left Ventricular (Lv) Pacemaker Electrode
FDA Pre-Market Approval
FDA Class 3
·ATTAIN ABILITY LV LEAD
Filler, Recombinant Human Bone Morphogenetic Protein, Collagen Scaffold, Osteoinduction
FDA Pre-Market Approval
FDA Class 3
·INFUSE BONE GRAFT
Stimulator, Autonomic Nerve, Implanted For Epilepsy
FDA Pre-Market Approval
FDA Class 3
·VNS THERAPY SYSTEM
Kit, Dna Detection, Human Papillomavirus
FDA Pre-Market Approval
FDA Class 3
·DIGENE HYBRID CAPTURE 2 (HC2) HPV DNA TEST & DIGENE HYBRID CAPTURE 2 (HC2) HIGH RISK HPV DNA TEST
Stent, Renal
FDA Pre-Market Approval
FDA Class 3
·FORMULA BALLOON-EXPANDABLE RENAL STENT SYSTEM
Implantable Cardioverter Defibrillator (Non-Crt)
FDA Pre-Market Approval
FDA Class 3
·CONCERTO ICD, II CRT-D, CONSULTA DF4 ICD, CONSULTA ICD,INSYNC MAXIMO ICD, II CRT-D,PROTECTA CRT-D, PROTECTA XT CRT-D
Pump, Infusion, Implanted, Programmable
FDA Pre-Market Approval
FDA Class 3
·Prometra Programmable Infusion Pump System
Pulmonary Valve Prosthesis Percutaneously Delivered
FDA Pre-Market Approval
Harmony TPV System
Prosthesis, Ankle, Uncemented, Non-Constrained
FDA Pre-Market Approval
FDA Class 3
·SCANDINAVIAN TOTAL ANKLE REPLACEMENT SYSTEM (STAR ANKLE)
Lenses, Soft Contact, Extended Wear
FDA Pre-Market Approval
FDA Class 3
·Eureka! Monthly (samfilcon A) Contact Lenses
Lenses, Soft Contact, Extended Wear
FDA Pre-Market Approval
FDA Class 3
·BAUSCH & LOMB SOFLENS TORIC (ALPHAFILCON A) VISIBILITY TINTED CONTACT LENSES