31 results · 20ms · Sources: EU EUDAMED, US FDA

System, Photopheresis, Extracorporeal

FDA Pre-Market Approval
FDA Class 3 ·Therakos Cellex Photopheresis System

Coronary Drug-Eluting Stent

FDA Pre-Market Approval
FDA Class 3 ·XIENCE V/nano Everolimus Eluting Coronary Stent System

Stent, Coronary

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

Coronary Drug-Eluting Stent

FDA Pre-Market Approval
FDA Class 3 ·XIENCE Prime/Xpedition/Alpine/Sierra Everolimus Eluting Coronary Stent System (SV, LL)

Prosthesis, Spinous Process Spacer/Plate

FDA Pre-Market Approval
FDA Class 3 ·Superion™ Indirect Decompression System (IDS) Kit, Vertiflex Instrument Platform (VIP) Kit

Coronary Drug-Eluting Stent

FDA Pre-Market Approval
FDA Class 3 ·SLENDER Sirolimus-Eluting Coronary Stent Integrated Delivery System(SLENDER IDS®), DIRECT Sirolimus-Eluting Coronary Ste

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval
FDA Class 3 ·EVERA S DR ID, EVERA S VR ICD, EVERA XT DR ICD, EVERA XT VR ICD

Coronary Drug-Eluting Stent

FDA Pre-Market Approval
FDA Class 3 ·Svelte SLENDER® Sirolimus-Eluting Coronary Stent Integrated Delivery System (SLENDER IDS®), Svelte DIRECT Sirolimus-Elut

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval
FDA Class 3 ·EVERA MRI DF-1 ICD, EVERA MRI IDC, EVERA S DR ICD, EVERA S VR ICD, EVERA XT DR ICD, EVERA XT VR ICD, VISIA AF MRI DF1 IC

Pulse Generator, Permanent, Implantable

FDA Pre-Market Approval
FDA Class 3 ·ELITE,ELITE II,MINUET,PREVA,PRODIGY,THERA D,THERA DR IPGS, THERA ID PG,THERA IPG,THERA S IPG,THERA SR IPG,THERA VDD IPG,

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval
FDA Class 3 ·Evera MRI DF-1 ICD, Evera MRI ICD, Mirro MRI DR ICD, Mirro MRI VR ICD, Primo MRI DR ICVD, Primo MRI VR ID, Visia AF MRI