10,000 results · 62ms · Sources: EU EUDAMED, US FDA

Lenses, Soft Contact, Extended Wear

FDA Pre-Market Approval
FDA Class 3 ·METHAFILCON A AND METHAFILCON B SOFT (HYDROPHILIC) EXTENDED-WEAR CONTACT LENSES

Permanent Pacemaker Electrode

FDA Pre-Market Approval
FDA Class 3 ·MYOPORE SUTURELESS MYOCARDIAL PACING LEAD

Hepatitis Viral B Dna Detection

FDA Pre-Market Approval
FDA Class 3 ·COBAS HBV TEST

Drug Eluting Permanent Right Ventricular (Rv) Or Right Atrial (Ra) Pacemaker Electrodes

FDA Pre-Market Approval
FDA Class 3 ·CapSureFix Lead, CapSureFix Novus Lead, Vitatron Crystalline Active Fixation Lead

Prosthesis, Breast, Noninflatable, Internal, Silicone Gel-Filled

FDA Pre-Market Approval
FDA Class 3 ·MEMORYGEL SILICONE GEL-FILLED BREAST IMPLANTS

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval
FDA Class 3 ·Cobalt MRI ICD, Cobalt XT MRI ICD, Crome MRI ICD, Evera MRI DF-1 ICD, Evera MRI ICD, Evera S DR ICD, Evera S VR ICD, Eve

Heart-Valve, Mechanical

FDA Pre-Market Approval
FDA Class 3 ·CARBOMEDICS PROSTHETIC HEART VALVE (CPHV)

Shunt, Portosystemic, Endoprosthesis

FDA Pre-Market Approval
FDA Class 3 ·WALLSTENT TRANSJUGULAR PORTOSYSTEMICSHUNT (TIPS) ENDOPROSTHESIS WITH UNISTEP PLUS DELIVERY SYSTEM

Replacement Heart-Valve

FDA Pre-Market Approval
FDA Class 3 ·Carpentier-Edwards Perimount Pericardial Aortic Bioprosthesis, Carpentier-Edwards Perimount Theon Percardial Aortic Biop

Iliac Covered Stent, Arterial

FDA Pre-Market Approval
FDA Class 3 ·GORE® VIABAHN® VBX Balloon Expandable Endoprosthesis

Aortic Valve, Prosthesis, Percutaneously Delivered

FDA Pre-Market Approval
FDA Class 3 ·Edwards SAPIEN XT Transcatheter Heart Valve

Heart-Valve, Non-Allograft Tissue

FDA Pre-Market Approval
FDA Class 3 ·Epic™, Epic™ Supra and Epic™ Plus Tissue Heart Valves, Biocor™ and Biocor™ Supra Tissue Heart Valves

Heart-Valve, Mechanical

FDA Pre-Market Approval
FDA Class 3 ·ON-X PROSTHETIC HEART VALVE

Test, Hepatitis B (B Core, Be Antigen, Be Antibody, B Core Igm)

FDA Pre-Market Approval
FDA Class 3 ·ETI-AB-COREK PLUS KIT

Telescope, Implantable, Miniature

FDA Pre-Market Approval
FDA Class 3 ·VISIONCARE'S IMPLANTABLE MINIATURE TELESCOPE

Permanent Defibrillator Electrodes

FDA Pre-Market Approval
FDA Class 3 ·ATTAIN STARFIX LEAD

Replacement Heart-Valve

FDA Pre-Market Approval
FDA Class 3 ·EDWARDS PRIMA PLUS STENTLESS PORCINE BIOPROSTHESIS

Stimulator, Autonomic Nerve, Implanted For Epilepsy

FDA Pre-Market Approval
FDA Class 3 ·VNS THERAPY SYSTEM

Replacement Heart-Valve

FDA Pre-Market Approval
FDA Class 3 ·CARPENTIER-EDWARDS S.A.V. AORTIC PORCINE BIOPROSTHESIS

Implantable Pulse Generator, Pacemaker (Non-Crt)

FDA Pre-Market Approval
FDA Class 3 ·Attain Bipolar OTW Lead, Attain OTW LV Lead