897 results
·
18ms
·
Sources: EU EUDAMED, US FDA
Filters
Classification: FDA Class 3
×
Transcatheter Septal Occluder
FDA Pre-Market Approval
FDA Class 3
·GORE CARDIOFORM Septal Occluder and GORE CARDIOFORM ASD Occluder
Implantable Pulse Generator, Pacemaker (Non-Crt)
FDA Pre-Market Approval
FDA Class 3
·CAPSUREFIX MRI LEAD
Cardiac Ablation Percutaneous Catheter
FDA Pre-Market Approval
FDA Class 3
·SMARTABLATE Irrigation Tubing Set
Automated Insulin Dosing , Threshold Suspend
FDA Pre-Market Approval
FDA Class 3
·t:slim X2 Insulin Pump with Basal-IQ Technology
Pump, Infusion, Insulin, To Be Used With Invasive Glucose Sensor
FDA Pre-Market Approval
FDA Class 3
·t:slim X2 Insulin Pump with Dexcom G5 Mobile CGM System
Ventricular (Assist) Bypass
FDA Pre-Market Approval
FDA Class 3
·HeartWare Ventricular Assist System
Enzyme Immunoassay, Fetal Fibronectin
FDA Pre-Market Approval
FDA Class 3
·Rapid fFN for the TLiIQ System
Prosthesis, Breast, Noninflatable, Internal, Silicone Gel-Filled
FDA Pre-Market Approval
FDA Class 3
·MEMORYGEL BREAST IMPLANT
Prosthesis, Breast, Noninflatable, Internal, Silicone Gel-Filled
FDA Pre-Market Approval
FDA Class 3
·Silicone Gel Breast Implants
Prosthesis, Breast, Noninflatable, Internal, Silicone Gel-Filled
FDA Pre-Market Approval
FDA Class 3
·SILICONE-FILLED NATRELLE BIOCELL TEXTURED SHELL SURFACE
Prosthesis, Breast, Noninflatable, Internal, Silicone Gel-Filled
FDA Pre-Market Approval
FDA Class 3
·Sientra Silicone Gel Breast Implants
Prosthesis, Breast, Noninflatable, Internal, Silicone Gel-Filled
FDA Pre-Market Approval
FDA Class 3
·MENTOR MEMORYSHAPE BREAST IMPLANTS
Prosthesis, Breast, Noninflatable, Internal, Silicone Gel-Filled
FDA Pre-Market Approval
FDA Class 3
·MemoryGel Silicone Gel-Filled Breast Implants
Prosthesis, Breast, Noninflatable, Internal, Silicone Gel-Filled
FDA Pre-Market Approval
FDA Class 3
·NATRELLE SILICONE-FILLED BREAST IMPLANTS
Prosthesis, Breast, Noninflatable, Internal, Silicone Gel-Filled
FDA Pre-Market Approval
FDA Class 3
·MEMORYGEL SILICONE GEL-FILLED BREAST IMPLANTS
Prosthesis, Breast, Noninflatable, Internal, Silicone Gel-Filled
FDA Pre-Market Approval
FDA Class 3
·Mentor MemoryShape Breast Implants
Prosthesis, Breast, Noninflatable, Internal, Silicone Gel-Filled
FDA Pre-Market Approval
FDA Class 3
·SIENTRA SILICONE GEL BREAST IMPLANTS
Prosthesis, Breast, Noninflatable, Internal, Silicone Gel-Filled
FDA Pre-Market Approval
FDA Class 3
·MENTOR MEMORYSHAPE BREAST IMPLANTS
Prosthesis, Breast, Noninflatable, Internal, Silicone Gel-Filled
FDA Pre-Market Approval
FDA Class 3
·Mentor Memoryshape, Breast Implants
Prosthesis, Breast, Noninflatable, Internal, Silicone Gel-Filled
FDA Pre-Market Approval
FDA Class 3
·MENTOR MEMORYGEL SILICONE GEL-FILLED BREAST IMPLANTS