3,096 results · 17ms · Sources: EU EUDAMED, US FDA

System, Endovascular Graft, Aortic Aneurysm Treatment

FDA Pre-Market Approval
FDA Class 3 ·AFX ENDOVASCULAR AAA SYSTEM

System, Colorectal Neoplasia, Dna Methylation And Hemoglobin Detection

FDA Pre-Market Approval
FDA Class 3 ·COLOGUARD

Tricuspid Valve Repair Device, Percutaneously Delivered

FDA Pre-Market Approval
FDA Class 3 ·TriClip G4 System

Sealant, Polymerizing

FDA Pre-Market Approval
FDA Class 3 ·COSEAL SURGICAL SEALANT

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

FDA Pre-Market Approval
FDA Class 3 ·R3 DELTA CERAMIC HIP SYSTEM

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

FDA Pre-Market Approval
FDA Class 3 ·ARCHITECT CORE

Defibrillator, Automatic Implantable Cardioverter, With Cardiac Resynchronization (Crt-D)

FDA Pre-Market Approval
FDA Class 3 ·Amplia MRI CRT-D, Amplia MRI Quad CRT-D, Claria MRI CRT-D, Claria MRI Quad CRT-D, Compia MRI CRT-D and Compia MRI Quad C

Stent, Coronary

FDA Pre-Market Approval
FDA Class 3 ·MULTI-LINK 8 Coronary, 8 LL Coronary, and 8 SV Coronary Stent System

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval
FDA Class 3 ·TRANSVENE LEAD

System, Endovascular Graft, Aortic Aneurysm Treatment

FDA Pre-Market Approval
FDA Class 3 ·Alto Abdominal Stent Graft System

Permanent Defibrillator Electrodes

FDA Pre-Market Approval
FDA Class 3 ·MEDTRONIC ATTAIN STARFIX MODEL 4195

Implanted Electrical Device Intended For Treatment Of Fecal Incontinence

FDA Pre-Market Approval
FDA Class 3 ·InterStim® Sacral Nerve Stimulation Therapy System / Bowel Control

Immunohistochemistry Assay, Antibody, Programmed Death-Ligand 1

FDA Pre-Market Approval
FDA Class 3 ·Ventana PD-L1 (SP263)

Lenses, Soft Contact, Extended Wear

FDA Pre-Market Approval
FDA Class 3 ·comfilcon A Soft (Hydrophilic) Extended Wear Contact Lenses

Stent, Superficial Femoral Artery, Drug-Eluting

FDA Pre-Market Approval
FDA Class 3 ·Eluvia Drug Eluting Stent System

System, Appendage Closure, Left Atrial

FDA Pre-Market Approval
FDA Class 3 ·WATCHMAN FLX™ Left Atrial Appendage Closure Device with Delivery 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

Device, Hemostasis, Vascular

FDA Pre-Market Approval
FDA Class 3 ·Perclose ProGlide® Suture-Mediated Closure System, Prostar® XL Percutaneous Vascular Surgical System

Sealant, Dural

FDA Pre-Market Approval
FDA Class 3 ·DuraSeal Exact Spine Sealant System

Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Metal/Polymer, Mobile Bearing

FDA Pre-Market Approval
FDA Class 3 ·LCS Total Knee System