2,317 results · 17ms · Sources: EU EUDAMED, US FDA

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

FDA Pre-Market Approval
FDA Class 3 ·Mentor MemoryShape® Silicone Gel-Filled Breast Implant PMA

Aid, Surgical, Viscoelastic

FDA Pre-Market Approval
FDA Class 3 ·DUOVISC LABELING INSERT FOR PROVISC(R) SODIUM HYALURONATE PMA

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

FDA Pre-Market Approval
FDA Class 3 ·Mentor MemoryGel® Silicone Gel-Filled Breast Implant PMA

Stimulator, Hypoglossal Nerve, Implanted, Apnea

FDA Pre-Market Approval
FDA Class 3 ·INSPIRE II UPPER AIRWAY STIMULATOR

Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Ceramic/Metal, Cemented Or Uncemented

FDA Pre-Market Approval
FDA Class 3 ·R3 Delta Ceramic Hip System, and POLARSTEM PMA Auxiliary Products

Oximeter, Fetal Pulse

FDA Pre-Market Approval
FDA Class 3 ·SERIES 50 XMO (MODEL M1350C) FETAL/MATERNAL MONITOR SYSTEM WITH INTEGRATED FETAL OXYGEN SATURATION MONITORING

Oximeter, Fetal Pulse

FDA Pre-Market Approval
FDA Class 3 ·OXIFIRST FETAL OXYGEN SATURATION MONITORING SYSTEM

Oximeter, Fetal Pulse

FDA Pre-Market Approval
FDA Class 3 ·OXIFIRST FETAL OXYGEN SATURATION MONITORING SYSTEM

Normothermic Machine Perfusion System For The Preservation Of Standard Criteria Donor Lungs Prior To Transplantation

FDA Pre-Market Approval
FDA Class 3 ·Organ Care System™ (OCS) Lung System

Normothermic Machine Perfusion System For The Preservation Of Standard Criteria Donor Lungs Prior To Transplantation

FDA Pre-Market Approval
FDA Class 3 ·Organ Care System™ (OCS™) Lung

Intracranial Coil-Assist Stent

FDA Pre-Market Approval
FDA Class 3 ·Neuroform Atlas® Stent System

Normothermic Machine Perfusion System For The Preservation Of Standard Criteria Donor Lungs Prior To Transplantation

FDA Pre-Market Approval
FDA Class 3 ·Organ Care System (OCS™) Lung System

Normothermic Machine Perfusion System For The Preservation Of Standard Criteria Donor Lungs Prior To Transplantation

FDA Pre-Market Approval
FDA Class 3 ·Organ Care System (OCS™) Lung System

Oximeter, Fetal Pulse

FDA Pre-Market Approval
FDA Class 3 ·COROMETRICS MODEL 120 SERIES MATERNAL/FETAL MONITOR W/INTEGRATED FETAL PULSE OXIMETRY

Intracranial Coil-Assist Stent

FDA Pre-Market Approval
FDA Class 3 ·Low-Profile Visualized Intraluminal Support (LVIS) and LVIS Jr.

Oximeter, Fetal Pulse

FDA Pre-Market Approval
FDA Class 3 ·OXIFIRST(TM) FETAL SENSOR FS14-SERIES

Intracranial Coil-Assist Stent

FDA Pre-Market Approval
FDA Class 3 ·Low-Profile Visualized Intraluminal Support (LVIS) and LVIS Jr.

Intracranial Coil-Assist Stent

FDA Pre-Market Approval
FDA Class 3 ·Neuroform Atlas® Stent System

Oximeter, Fetal Pulse

FDA Pre-Market Approval
FDA Class 3 ·OXI FIRST FETAL OXYGEN SATURATION MONITORING SYSTEM

Intracranial Coil-Assist Stent

FDA Pre-Market Approval
FDA Class 3 ·Low-Profile Visualized Intraluminal Support (LVIS), LVIS Jr