80 results · 21ms · Sources: EU EUDAMED, US FDA

Intrasaccular Flow Disruption Device

FDA Pre-Market Approval
FDA Class 3 ·Woven EndoBridge Aneurysm Embolization (WEB) System

Intrasaccular Flow Disruption Device

FDA Pre-Market Approval
FDA Class 3 ·Woven EndoBridge (WEB) Aneurysm Embolization System

Intrasaccular Flow Disruption Device

FDA Pre-Market Approval
FDA Class 3 ·Woven EndoBridge (WEB) Aneurysm Embolization System

Intrasaccular Flow Disruption Device

FDA Pre-Market Approval
FDA Class 3 ·WEB Aneurysm Embolization System

Intrasaccular Flow Disruption Device

FDA Pre-Market Approval
FDA Class 3 ·Woven EndoBridge (WEB) Aneurysm Embolization System

Intrasaccular Flow Disruption Device

FDA Pre-Market Approval
FDA Class 3 ·Woven EndoBridge (WEB) Aneurysm Embolization System (WEB 017)

Intrasaccular Flow Disruption Device

FDA Pre-Market Approval
FDA Class 3 ·Woven EndoBridge (WEB) Aneurysm Embolization System

Intrasaccular Flow Disruption Device

FDA Pre-Market Approval
FDA Class 3 ·Woven EndoBridge Aneurysm Embolization (WEB) System

Intrasaccular Flow Disruption Device

FDA Pre-Market Approval
FDA Class 3 ·Woven EndoBridge (WEB) Aneurysm Embolization System

Intrasaccular Flow Disruption Device

FDA Pre-Market Approval
FDA Class 3 ·Woven EndoBridge (WEB) Aneurysm Embolization System

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 (IPP) with and without InhibiZone, AMS Ambicor IPP

Lenses, Soft Contact, Extended Wear

FDA Pre-Market Approval
FDA Class 3 ·FRESHLOOK UV (PHEMFILCON A) SPHERICAL SOFT CONTACT LENSES FOR EXTENDED WEAR

Fluid, Intraocular

FDA Pre-Market Approval
FDA Class 3 ·PERFLUORON

Sealant, Polymerizing

FDA Pre-Market Approval
FDA Class 3 ·COSEAL SURGICAL SEALANT (PREMIXED)

Permanent Pacemaker Electrode

FDA Pre-Market Approval
FDA Class 3 ·CYLOS FAMILY OF PULSE GENERATORS

Defibrillator, Implantable, Dual-Chamber

FDA Pre-Market Approval
FDA Class 3 ·LUMOS VR-T AND LUMOS DR-T IMPLANTABLE CARDIOVERTER DEFIBRILLATORS WITH 502.U ICS PROGRAMMER SOFTWARE, A-K00.4.U EPR/...

Stimulator, Spinal-Cord, Totally Implanted For Pain Relief

FDA Pre-Market Approval
FDA Class 3 ·WaveWriter Alpha, WaveWriter Alpha 16

Stimulator, Electrical, Implanted, For Parkinsonian Symptoms

FDA Pre-Market Approval
FDA Class 3 ·Vercise Genus R32, Vercise Genus R16

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

FDA Pre-Market Approval
FDA Class 3 ·HORIZON(TM) YAG LASER MODEL 2000