247 results · 22ms · Sources: EU EUDAMED, US FDA

Material, Dressing, Surgical, Polylactic Acid

FDA Pre-Market Approval
FDA Class 3 ·COLLACOTE/COLLATAPE/COLLA[LUG ABSORBABLE COLLAGEN WOUND DRESS

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval
FDA Class 3 ·Emblem S-ICD Programmer - Plexus SMT Mfg. Line

Device, Angioplasty, Laser, Coronary

FDA Pre-Market Approval
FDA Class 3 ·CVX-300 Excimer Laser System and ELCA Coronary Atherectomy Catheters

System, Endovascular Graft, Aortic Aneurysm Treatment

FDA Pre-Market Approval
FDA Class 3 ·ZENITH AAA ENDOVASCULAR GRAFT WITH H&L-B ONE SHOT INTRODUCTION SYSTEM

Assay,Enzyme Linked Immunosorbent,Parvovirus B19 Igg

FDA Pre-Market Approval
FDA Class 3 ·LIAISON Biotrin Parvovirus B19 lgG Plus and LIAISON Biotrin Control Parvovirus B19 IgG Plus

Device, Hemostasis, Vascular

FDA Pre-Market Approval
FDA Class 3 ·MYNX VASCULAR CLOSURE DEVICE

System, Endovascular Graft, Aortic Aneurysm Treatment

FDA Pre-Market Approval
FDA Class 3 ·GORE EXCLUDER AAA ENDOPROSTHESIS

System, Endovascular Graft, Aortic Aneurysm Treatment

FDA Pre-Market Approval
FDA Class 3 ·ZENITH FLEX AAA ENDOVASCULAR GRAFT

System, Endovascular Graft, Aortic Aneurysm Treatment

FDA Pre-Market Approval
FDA Class 3 ·GORE EXCLUDER BIFURCATED ENDOPROSTHESIS

Dressing, Wound And Burn, Interactive

FDA Pre-Market Approval
FDA Class 3 ·APLIGRAF

System, Endovascular Graft, Aortic Aneurysm Treatment

FDA Pre-Market Approval
FDA Class 3 ·GORE EXCLUDER BIFURCATED ENDOPROSTHESIS

Heart-Valve, Non-Allograft Tissue

FDA Pre-Market Approval
FDA Class 3 ·EDWARDS INTUITY ELITE Valve/Delivery System

System, Endovascular Graft, Aortic Aneurysm Treatment

FDA Pre-Market Approval
FDA Class 3 ·EXCLUDER TM BIFURCATED ENDOPROSTHESIS

System, Endovascular Graft, Aortic Aneurysm Treatment

FDA Pre-Market Approval
FDA Class 3 ·GORE EXCLUDER AAA Endoprosthesis

System, Endovascular Graft, Aortic Aneurysm Treatment

FDA Pre-Market Approval
FDA Class 3 ·GORE EXCLUDER AAA Endoprosthesis

System, Endovascular Graft, Aortic Aneurysm Treatment

FDA Pre-Market Approval
FDA Class 3 ·GORE EXCLUDER AAA ENDOPROSTHESIS

System, Endovascular Graft, Aortic Aneurysm Treatment

FDA Pre-Market Approval
FDA Class 3 ·POWERLINK SYSTEM WITH INTUI TRAK DELIVERY SYSTEM

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval
FDA Class 3 ·MEDTRONIC SPRINT FIDELIS LEAD

Stent, Coronary

FDA Pre-Market Approval
FDA Class 3 ·PALMAZ-SCHATZ(TM) BALLOON EXPANDABLE STENT WITH DELIVERY SYSTEM

Stimulator, Spinal-Cord, Totally Implanted For Pain Relief

FDA Pre-Market Approval
FDA Class 3 ·SENZA SPINAL CORD STIMULATION (SCS) SYSTEM