9,662 results
·
41ms
·
Sources: EU EUDAMED, US FDA
Lenses, Soft Contact, Extended Wear
FDA Pre-Market Approval
FDA Class 3
·Biofinity Sphere, Biofinity Toric, Biofinity Multifocal, Biofinity Energys, Biofinity Sphere XR
Stimulator, Electrical, Implanted, For Parkinsonian Tremor
FDA Pre-Market Approval
FDA Class 3
·Activa Deep Brain Stimulation Therapy System
Sensor, Glucose, Invasive
FDA Pre-Market Approval
FDA Class 3
·FreeStyle Libre Pro Flash Glucose Monitoring System
Acid, Hyaluronic, Intraarticular
FDA Pre-Market Approval
FDA Class 3
·EUFLEXXA
System, Endovascular Graft, Arteriovenous (Av) Dialysis Access Circuit Stenosis Treatment
FDA Pre-Market Approval
FDA Class 3
·GORE VIABAHN ENDOPROSTHESIS AND GORE VIABAHN ENDOPROSTHESIS WITH HEPARIN BIOACTIVE SURFACE
Processor, Cervical Cytology Slide, Automated
FDA Pre-Market Approval
FDA Class 3
·PRESERVCYT SOLUTION ALTERNATIVE TRANSPORT MEDIUM
Catheters, Transluminal Coronary Angioplasty, Percutaneous
FDA Pre-Market Approval
FDA Class 2
·VOYAGER RX CORONARY DILATATION CATHETER
Implant, Cochlear
FDA Pre-Market Approval
FDA Class 3
·NUCLEUS 22 CHANNEL COCHLEAR IMPLANT SYSTEM
Lenses, Soft Contact, Extended Wear
FDA Pre-Market Approval
FDA Class 3
·OCUFILCON D SOFT (HYDROPHILIC) CONTACT LENSES
Hybrid Stent Graft, Thoracic Aortic Lesion Treatment
FDA Pre-Market Approval
FDA Class 3
·Thoraflex Hybrid
Sensor, Glucose, Invasive, Non-Adjunctive, Factory-Calibrated, User-Initiated
FDA Pre-Market Approval
FDA Class 3
·FreeStyle Libre 14 day Flash Glucose Monitoring System
Enzyme Immunoassay, Fetal Fibronectin
FDA Pre-Market Approval
FDA Class 3
·Rapid fFN for the TLiIQ System
Sensor, Glucose, Invasive
FDA Pre-Market Approval
FDA Class 3
·FreeStyle Libre Pro Flash Glucose Monitoring System
Defibrillator, Automatic Implantable Cardioverter, With Cardiac Resynchronization (Crt-D)
FDA Pre-Market Approval
FDA Class 3
·QUICKFLEX U AND QUARTET CRT LEADS
Assay, Enzyme Linked Immunosorbent, Hepatitis C Virus
FDA Pre-Market Approval
FDA Class 2
·ELECSYS ANTI-HCV ON COBAS E 411
Test, Hepatitis B (B Core, Be Antigen, Be Antibody, B Core Igm)
FDA Pre-Market Approval
FDA Class 3
·ELECSYS HBSAG
Implant, Cochlear
FDA Pre-Market Approval
FDA Class 3
·NUCLEUS 22 CHANNEL COCHLEAR IMPLANT SYSTEM
Test, Hepatitis B (B Core, Be Antigen, Be Antibody, B Core Igm)
FDA Pre-Market Approval
FDA Class 3
·ELECSYS ANTI-HBC IGM ON COBAS E 411
Test, Hepatitis B (B Core, Be Antigen, Be Antibody, B Core Igm)
FDA Pre-Market Approval
FDA Class 3
·ELECSYS ANTI-HBC IGM ON MODULAR ANALYTICS E170
Assay, Enzyme Linked Immunosorbent, Hepatitis C Virus
FDA Pre-Market Approval
FDA Class 2
·ELECSYS ANTI-HCV ON COBAS E 601