3,496 results · 16ms · Sources: EU EUDAMED, US FDA

Diaphragmatic/Phrenic Nerve Laparoscopically-Implanted Stimulator

FDA Pre-Market Approval
FDA Class 3 ·NeuRX Diaphragm Pacing System (DPS)

Implant, Hearing, Active, Middle Ear, Partially Implanted

FDA Pre-Market Approval
FDA Class 3 ·VIBRANT SOUNDBRIDGE

Implant, Dermal, For Aesthetic Use

FDA Pre-Market Approval
FDA Class 3 ·JUVEDERM ULTRA XC INJECTABLE GEL

Intracranial Coil-Assist Stent

FDA Pre-Market Approval
FDA Class 3 ·Neuroform Atlas® Stent System

Intraocular Lens

FDA Pre-Market Approval
FDA Class 3 ·POSTERIOR CHAMBER INTRAOCULAR LENSES (TIER A SUBMISSION)

Implant, Cochlear

FDA Pre-Market Approval
FDA Class 3 ·CLARION CII BIONIC EAR, HIFOCUS ELECTRODE WITHOUT POSITIONER (MODEL AB-5100H-11A) & HIRES SOFTWARE (MODEL CI-6055)

Automated External Defibrillators (Non-Wearable)

FDA Pre-Market Approval
FDA Class 3 ·LIFEPAK® CR2 Defibrillator

Excimer Laser System

FDA Pre-Market Approval
FDA Class 3 ·WAVELIGHT EX500 LASER SYSTEM

Excimer Laser System

FDA Pre-Market Approval
FDA Class 3 ·WAVELIGHT EX500 LASER SYSTEM

Transcatheter Septal Occluder

FDA Pre-Market Approval
FDA Class 3 ·AMPLATZER PFO OCCLUDER

Intraocular Lens

FDA Pre-Market Approval
FDA Class 3 ·MODIFIED C-LOOP, UV-ABSORBING POSTERIOR CHAMBER INTRAOCULAR LENSES

Assay,Enzyme Linked Immunosorbent,Parvovirus B19 Igm

FDA Pre-Market Approval
FDA Class 3 ·ZEUS ELISA PARVOVIRUS B19 IGM TEST SYSTEM

Intracranial Aneurysm Flow Diverter

FDA Pre-Market Approval
FDA Class 3 ·Pipeline Flex Embolization Device

Intraocular Lens

FDA Pre-Market Approval
FDA Class 3 ·ACRYSOF UV-ABSORBING SINGLE-PIECE PC IOL

Excimer Laser System

FDA Pre-Market Approval
FDA Class 3 ·LASERSCAN LSX EXCIMER LASER SYSTEM

Intraocular Lens

FDA Pre-Market Approval
FDA Class 3 ·HYDROVIEW COMPOSITE HYGROGEL FOLDABLE ULTRAVIOLET-ABSORBING POSTERIOR CHAMBER INTRAOCULAR (IOL)

Implant, Corneal, Refractive

FDA Pre-Market Approval
FDA Class 3 ·INTACS PRESCRIPTION INSERTS/INTACS CORNEAL IMPLANTS

Intraocular Lens

FDA Pre-Market Approval
FDA Class 3 ·ACRYSOF SINGLE-PIECE POSTERIOR CHAMBER IOL

Neuromodulator For Obesity

FDA Pre-Market Approval
FDA Class 3 ·MAESTRO RECHARGEABLE SYSTEM

Implant, Cochlear

FDA Pre-Market Approval
FDA Class 3 ·HARMONY HIRESOLUTION BIONIC EAR SYSTEM