2,485 results · 19ms · Sources: EU EUDAMED, US FDA

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

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

Prosthesis, Penis, Inflatable

FDA Pre-Market Approval
FDA Class 3 ·AMS 700 Inflatable Penile Prosthesis (IPP) (with and without InhibiZone)

Prosthesis, Breast, Inflatable, Internal, Saline

FDA Pre-Market Approval
FDA Class 3 ·NATRELLE SALINE-FILLED BREAST IMPLANTS

Stimulator, Electrical, Implanted, For Parkinsonian Tremor

FDA Pre-Market Approval
FDA Class 3 ·DBS System 4CH Lead / DBS System 8CH Directional Lead

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

FDA Pre-Market Approval
FDA Class 3 ·Sientra OPUS Silicone Gel Breast Implants

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

FDA Pre-Market Approval
FDA Class 3 ·Sientra OPUS Silicone Gel Breast Implants

Intracranial Aneurysm Flow Diverter

FDA Pre-Market Approval
FDA Class 3 ·Pipeline™ Flex Embolization Device with Shield Technology™, Pipeline™ Vantage Embolization Device with Shield Technology

Defibrillator, Implantable, Dual-Chamber

FDA Pre-Market Approval
FDA Class 3 ·IPERIA 7 HF-T (DR-1) & (DF-4); INVENTRA 7 HF-T (DF-1) & (DF-4)

Implant, Hearing, Active, Middle Ear, Totally Implanted

FDA Pre-Market Approval
FDA Class 3 ·ESTEEM

Automated External Defibrillators (Non-Wearable)

FDA Pre-Market Approval
FDA Class 3 ·Lifeline/ReviveR DDU-100, Lifeline/ReviveR AUTO DDU-120, Lifeline/ReviveR VIEW DDU-2300, Lifeline/ReviveR VIEW AUTO DDU-

Cardiac Ablation Percutaneous Catheter

FDA Pre-Market Approval
FDA Class 3 ·BOSTON SCIENTIFIC XP APM (AUTOMATIC PERSONALITY MODULE) UNIT, MODEL 822T

Device, Impotence, Mechanical/Hydraulic

FDA Pre-Market Approval
FDA Class 3 ·TITAN INFLATABLE PENILE PROSTHESIS

Device, Impotence, Mechanical/Hydraulic

FDA Pre-Market Approval
FDA Class 3 ·TITAN INFLATABLE PENILE PROSTHESIS

Fluid, Intraocular

FDA Pre-Market Approval
FDA Class 3 ·Silikon 1000

Fluid, Intraocular

FDA Pre-Market Approval
FDA Class 3 ·SILIKON 1000

Fluid, Intraocular

FDA Pre-Market Approval
FDA Class 3 ·Silikon 1000

Fluid, Intraocular

FDA Pre-Market Approval
FDA Class 3 ·Silikon 1000

Fluid, Intraocular

FDA Pre-Market Approval
FDA Class 3 ·Silikon 1000

Fluid, Intraocular

FDA Pre-Market Approval
FDA Class 3 ·SILIKON 1000

Fluid, Intraocular

FDA Pre-Market Approval
FDA Class 3 ·Silikon 1000