9,662 results · 41ms · Sources: EU EUDAMED, US FDA

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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