System, Endovascular Graft, Aortic Aneurysm Treatment

FDA Pre-Market Approval

FDA Class 3 ·Valiant Captivia Stent Graft ith the Captivia Delivery System

Lens, Multifocal Intraocular

FDA Pre-Market Approval

FDA Class 3 ·AcrySof ReSTOR Posterior Chamber Intraocular Lenses

Intraocular Lens

FDA Pre-Market Approval

FDA Class 3 ·Clareon Aspheric Hydrophobic Acrylic Intraocular Lens (with the AutonoMe Pre-Loaded Delivery System) Claeron Toric Asphe

Intraocular Lens

FDA Pre-Market Approval

FDA Class 3 ·AcrySof Posterior Chamber Intraocular Lens

Implant, Cochlear

FDA Pre-Market Approval

FDA Class 3 ·MED-EL COMBI 40+ COCHLEAR IMPLANT SYSTEM, MED-EL INSERTION TEST DEVICE (ITD)

Implantable Pulse Generator, Pacemaker (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·TELIGEN FAMILY

Implantable Pulse Generator, Pacemaker (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·COGNIS FAMILY

Automated External Defibrillators (Non-Wearable)

FDA Pre-Market Approval

FDA Class 3 ·TZ Medical Defibrillation Electrodes, Accessory Cables, and Connectors

Intraocular Lens

FDA Pre-Market Approval

FDA Class 3 ·TECNIS 1-Piece IOL; OptiBlue; Multifocal; Toric 1-Piece IOLs; TECNIS i Tee Preloaded Delivery System; Symfont Extended R

Stent, Superficial Femoral Artery

FDA Pre-Market Approval

FDA Class 3 ·BioMimics 3D Vascular Stent System

Device, Thermal Ablation, Endometrial

FDA Pre-Market Approval

FDA Class 3 ·HYDRO THERMABLATOR (HTA) ENDOMETRIAL ABLATION SYSTEM

System, Photopheresis, Extracorporeal

FDA Pre-Market Approval

FDA Class 3 ·Therakos Cellex Photopheresis System

S80 IMPLANTABLE CARDIAC PACING LEAD

FDA 510(k)

FDA Class 3 ·Cardiovascular

Electrical Impedance Spectrometer

FDA classification

FDA Class 3 ·Electrical Impedance Spectrometer

Alfapump System

FDA classification

FDA Class 3 ·Alfapump System

System, Colorectal Neoplasia, Dna Methylation And Hemoglobin Detection

FDA classification

FDA Class 3 ·System, Colorectal Neoplasia, Dna Methylation And Hemoglobin Detection

Material, Embolization, Neurovascular, Polymerizing Or Precipitating

FDA classification

FDA Class 3 ·Material, Embolization, Neurovascular, Polymerizing Or Precipitating

Filler, Bone Void, Synthetic Peptide

FDA classification

FDA Class 3 ·Filler, Bone Void, Synthetic Peptide

Condom, Female, Animal Tissue

FDA classification

FDA Class 3 ·Condom, Female, Animal Tissue

Fluorescence In Situ Hybridization, Platelet-Derived Growth Factor Receptor, Beta Polypeptide (Pdgfrb), Rearrangement

FDA classification

FDA Class 3 ·Fluorescence In Situ Hybridization, Platelet-Derived Growth Factor Receptor, Beta Polypeptide (Pdgfrb), Rearrangement