2,479 results · 22ms · Sources: EU EUDAMED, US FDA

System, Endovascular Graft, Aortic Aneurysm Treatment

FDA Pre-Market Approval
FDA Class 3 ·Valiant Captivia Stent Graft ith the Captivia Delivery System

Implant, Cochlear

FDA Pre-Market Approval
FDA Class 3 ·COMBI 40+ SYSTEM WITH C40+ OR PULSARCI100 COCHLEAR IMPLANTS

Device, Incontinence, Mechanical/Hydraulic

FDA Pre-Market Approval
FDA Class 3 ·AMS 800 ARTIFICIAL URINARY SPHINCTER

Prosthesis, Penis, Inflatable

FDA Pre-Market Approval
FDA Class 3 ·AMS 700 INFLATABLE PENILE PROSTHESIS

Excimer Laser System

FDA Pre-Market Approval
FDA Class 3 ·WaveLight Analyzer II, ALLEGRO Topolyzer VARIO, Patient Bed Swivel

Excimer Laser System

FDA Pre-Market Approval
FDA Class 3 ·ALLEGRO Topolyzer VARIO and Patient Bed Swivel

Implantable Pacemaker Pulse-Generator

FDA Pre-Market Approval
FDA Class 3 ·Reply/Esprit (5th generation) Electric Hybrid Module

Automated External Defibrillators (Non-Wearable)

FDA Pre-Market Approval
FDA Class 3 ·Zoll R Series

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval
FDA Class 3 ·VENTAK MINI II+ HE, MINI IV, MINI IV+ PULSE GENERATORS

Kit, Test, Alpha-Fetoprotein For Neural Tube Defects

FDA Pre-Market Approval
FDA Class 3 ·AUTODELFIA HAFP KIT

Kit, Test, Alpha-Fetoprotein For Neural Tube Defects

FDA Pre-Market Approval
FDA Class 3 ·AutoDELFIA hAFP Test System

Kit, Test, Alpha-Fetoprotein For Neural Tube Defects

FDA Pre-Market Approval
FDA Class 3 ·AUTODELFIA HAFP TEST SYSTEM

Kit, Test, Alpha-Fetoprotein For Neural Tube Defects

FDA Pre-Market Approval
FDA Class 3 ·AutoDELFIA hAFP Test System

Implant, Corneal, Refractive

FDA Pre-Market Approval
FDA Class 3 ·KAMRA INLAY

Implant, Corneal, Refractive

FDA Pre-Market Approval
FDA Class 3 ·KAMRA INLAY

Kit, Test, Alpha-Fetoprotein For Neural Tube Defects

FDA Pre-Market Approval
FDA Class 3 ·AUTODELFIA HAFP TEST KIT

Implant, Corneal, Refractive

FDA Pre-Market Approval
FDA Class 3 ·KAMRA INLAY

Laser, Neodymium:Yag, Ophthalmic For Uses Other Than Posterior Capsulotomy & Cutting Pupillary

FDA Pre-Market Approval
FDA Class 3 ·PICOLAS NEODYMIUN-YAG OPHTHALMIC LASEER

Kit, Test, Alpha-Fetoprotein For Neural Tube Defects

FDA Pre-Market Approval
FDA Class 3 ·AUTODELFIA/DELFIA XPRESS HAFP

Kit, Test, Alpha-Fetoprotein For Neural Tube Defects

FDA Pre-Market Approval
FDA Class 3 ·AutoDELFIA hAFP Test Kit