10,000 results
·
476ms
·
Sources: EU EUDAMED, US FDA
Aid, Surgical, Viscoelastic
FDA Pre-Market Approval
FDA Class 3
·VISCOAT(R) VISCOELASTIC SOLUTION
Cytomegalovirus (Cmv) Dna Quantitative Assay
FDA Pre-Market Approval
FDA Class 2
·COBAS® AMPLIPREP/COBAS® TAQMAN® CMV TEST (CAP/CTM CMV TEST)
System, Endovascular Graft, Aortic Aneurysm Treatment
FDA Pre-Market Approval
FDA Class 3
·Endurant II/IIs Stent Graft System
Test, Hepatitis B (B Core, Be Antigen, Be Antibody, B Core Igm)
FDA Pre-Market Approval
FDA Class 3
·VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HBC REAGENT PACK AND CALIBRATOR
Lenses, Soft Contact, Extended Wear
FDA Pre-Market Approval
FDA Class 3
·H55 HYDROPHILIC CONTACT LENS
Material, Dressing, Surgical, Polylactic Acid
FDA Pre-Market Approval
FDA Class 3
·CollaCote, CollaTape®, CollaPlug®, Absorbable Collagen Wound Dressings for Dental Surgery
Stimulator, Electrical, Implantable, For Incontinence
FDA Pre-Market Approval
FDA Class 3
·INTERSTIM
Agent, Absorbable Hemostatic, Collagen Based
FDA Pre-Market Approval
FDA Class 3
·Helistat® Absorbable Collagen Hemostatic Agent and Helitene® Absorbable Collagen Hemostatic Agent Fibrillar Form
Implant, Dermal, For Aesthetic Use
FDA Pre-Market Approval
FDA Class 3
·RADIESSE® Injectable Implant, RADIESSE® Hands, RADIESSE® (+) Lidocaine Dermal Filler, RADIESSE® (+) Jawline
Lenses, Soft Contact, Extended Wear
FDA Pre-Market Approval
FDA Class 3
·SOFLENS (POLYMACON) VISIBILITY TINTED CONTACT LENS
Assay, Enzyme Linked Immunosorbent, Hepatitis C Virus
FDA Pre-Market Approval
FDA Class 2
·VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HCV REAGENT PACK AND CALIBRATOR
Intraocular Lens
FDA Pre-Market Approval
FDA Class 3
·BAUSCH & LOMB SURGICAL SOFLEX UV-ABSORBING SILICONE POSTERIOR CHAMBER LENS
Implantable Pulse Generator, Pacemaker (Non-Crt)
FDA Pre-Market Approval
FDA Class 3
·CAPSUREFIX MRI
Coronary Drug-Eluting Stent
FDA Pre-Market Approval
FDA Class 3
·CYPHER SIROLIMUS-ELUTING CORONARY STENT
Occluder, Internal Vessel, Temporary
FDA Pre-Market Approval
FDA Class 3
·LEGOO
Aortic Valve, Prosthesis, Percutaneously Delivered
FDA Pre-Market Approval
FDA Class 3
·Edwards SAPIEN 3 Transcatheter Heart Valve, Edwards SAPIEN 3 Ultra RESILIA Transcatheter Heart Valve
Pulse Generator, Permanent, Implantable
FDA Pre-Market Approval
FDA Class 3
·Astra S DR MRI IPG, Astra S SR MRI IPG, Astra XT DR MRI IPG, Astra XT SR MRI IPG, Azure S DR MRI IPG, Azure S SR MRI IPG
Agent, Bulking, Injectable For Gastro-Urology Use
FDA Pre-Market Approval
FDA Class 3
·Solesta Injectable Gel
FDA Pre-Market Approval
BRAVA CRT-D, VIVA S CRT-D, VIVA XT CRT-D
Device, Thermal Ablation, Endometrial
FDA Pre-Market Approval
FDA Class 3
·Mara Water Vapor Ablation System; Mara Water Vapor System; Mara Console