17 results · 19ms · Sources: EU EUDAMED, US FDA

Stent, Coronary

FDA Pre-Market Approval
FDA Class 3 ·RITHRON-XR CORONARY STENT SYSTEM

Stimulator, Spinal-Cord, Totally Implanted For Pain Relief

FDA Pre-Market Approval
FDA Class 3 ·Prospera SCS System, Resilience Percutaneous Lead, Embrace One, TrueLock

System, Endovascular Graft, Aortic Aneurysm Treatment

FDA Pre-Market Approval
FDA Class 3 ·Valiant Thoracic Stent Graft with the Captiva Delivery System

System, Endovascular Graft, Aortic Aneurysm Treatment

FDA Pre-Market Approval
FDA Class 3 ·Endurant Stent Graft System, Endurant II Stent Graft System, Endurant IIs Stent Graft System

EKG TRANSMITTER MODEL 5134

FDA 510(k)
FDA Class 3 ·Cardiovascular

Implantable Pacemaker Pulse-Generator

FDA Pre-Market Approval
FDA Class 3 ·OG(R) CARDIAC PACING SYSTEM

Transcatheter Septal Occluder (Atrial)

FDA Pre-Market Approval
FDA Class 3 ·Occlutech ASD Occluder, Occlutech Pistol Pusher (OPP), Occlutech ASD Occluder Procedure Pack

Transcatheter Septal Occluder (Atrial)

FDA Pre-Market Approval
FDA Class 3 ·Occlutech® ASD Occluder and Occlutech® Pistol Pusher

Transcatheter Septal Occluder (Atrial)

FDA Pre-Market Approval
FDA Class 3 ·Occlutech® ASD Occluder and Occlutech® Pistol Pusher

Acid, Hyaluronic, Intraarticular

FDA Pre-Market Approval
FDA Class 3 ·EUFLEXXA

Separator For Therapeutic Purposes, Membrane Automated Blood Cell/Plasma

FDA Pre-Market Approval
FDA Class 3 ·CURESIS PLASMA SEPARATOR

Test System, For Drugs Of Abuse

FDA Pre-Market Approval
FDA Class 3 ·AWARE TEST SYSTEM

Separator For Therapeutic Purposes, Membrane Automated Blood Cell/Plasma

FDA Pre-Market Approval
FDA Class 3 ·CURESIS PLASMA SEPARATOR

LINK CEMENTLESS SCREW-IN ACETABULAR CUP

FDA 510(k)
FDA Class 3 ·Orthopedic

LINK CEMENTLESS SCREW-IN ACETABULAR CUP

FDA 510(k)
FDA Class 3 ·Orthopedic

System, Balloon, Intra-Aortic And Control, Reprocessed

FDA classification
FDA Class 3 ·System, Balloon, Intra-Aortic And Control, Reprocessed

Automated External Defibrillators (Non-Wearable)

FDA Pre-Market Approval
FDA Class 3 ·ConMed PadPro Multifunction Electrodes, ConMed PadPro Multifunction Electrode Adapters