10,000 results
·
25ms
·
Sources: EU EUDAMED, US FDA
Filters
Classification: FDA Class 3
×
Aid, Surgical, Viscoelastic
FDA Pre-Market Approval
FDA Class 3
·HYDROXYPROPYLMETHYLCELLULOSE 2% OCCUCOAT (R)
Automated Insulin Dosing , Threshold Suspend
FDA Pre-Market Approval
FDA Class 3
·MINIMED 530G SYSTEM
Pulse Generator, Permanent, Implantable
FDA Pre-Market Approval
FDA Class 3
·SJM PACEMAKERS
Pulse Generator, Pacemaker, Implantable, With Cardiac Resynchronization (Crt-P)
FDA Pre-Market Approval
FDA Class 3
·FRONTIER/FRONTIER II/ANTHEM FAMILIES OF CRT-PS
Replacement Heart-Valve
FDA Pre-Market Approval
FDA Class 3
·DURAFLEX LOW PRESSURE PORCINE MITRAL BIOPROSTHESIS, DURAFLEX LOW PRESSURE MITRAL BIOPROSTHESIS WITH EXTENDED SUTURE RING
Replacement Heart-Valve
FDA Pre-Market Approval
FDA Class 3
·Hancock II Bioprosthesis
Device, Thermal Ablation, Endometrial
FDA Pre-Market Approval
FDA Class 3
·Minitouch 3.8 Era System (Minitouch System)
Lenses, Soft Contact, Extended Wear
FDA Pre-Market Approval
FDA Class 3
·SAUFLON(R) PW (LIDOFILCON B)
Stimulator, Electrical, Implanted, For Parkinsonian Symptoms
FDA Pre-Market Approval
FDA Class 3
·Vercise Genus Deep Brain Stimulation (DBS) System
Daily Wear Soft Contact Lens To Reduce The Progression Of Myopia
FDA Pre-Market Approval
FDA Class 3
·MiSight 1 Day (omafilcon A) Soft (Hydrophilic) Contact Lenses for Daily Wear
Implantable Pacemaker Pulse-Generator
FDA Pre-Market Approval
FDA Class 3
·AFFINITY, IDENTITY, INTEGRITY, AND FRONTIER FAMILY OF DEVICES
Replacement Heart-Valve
FDA Pre-Market Approval
FDA Class 3
·MOSAIC PORCINE BIOPROSTHESIS
Coronary Drug-Eluting Stent
FDA Pre-Market Approval
FDA Class 3
·CYPHER SIROLIMUS-ELUTING CORONARY STENT ON RAPTOR OTW DELIVERY SYSTEM/RAPTORRAIL RAPID EXCHANGE DELIVERY SYSTEM
System, Endovascular Graft, Aortic Aneurysm Treatment
FDA Pre-Market Approval
FDA Class 3
·POWERLINK SYSTEM WITH VISIFLEX SUREPASS DELIVERY CATHETER SYSTEM
Coronary Drug-Eluting Stent
FDA Pre-Market Approval
FDA Class 3
·ENDEAVOR ZOTAROLIMUS-ELUTING CORONARY STENT SYSTEM
Immunohistochemistry Assay, Antibody, Programmed Death-Ligand 1
FDA Pre-Market Approval
FDA Class 3
·PD-L1 IHC 22C3 PharmDx
Heart-Valve, Non-Allograft Tissue
FDA Pre-Market Approval
FDA Class 3
·Freestyle Bioprosthesis
Coronary Drug-Eluting Stent
FDA Pre-Market Approval
FDA Class 3
·Resolute Integrity Coronary Stent Systems
Intraocular Lens
FDA Pre-Market Approval
FDA Class 3
·ezSert Preloaded Delivery System
Stimulator, Spinal-Cord, Totally Implanted For Pain Relief
FDA Pre-Market Approval
FDA Class 3
·Senza Spinal Cord Stimulation (SCS) System