346 results
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19ms
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Sources: EU EUDAMED, US FDA
Filters
Classification: FDA Class 3
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Aspiration Therapy System
FDA Pre-Market Approval
FDA Class 3
·AspireAssist
Implant, Cochlear
FDA Pre-Market Approval
FDA Class 3
·HIRESOLUTION BIONIC EAR SYSTEM
Stimulator, Bone Growth, Non-Invasive
FDA Pre-Market Approval
FDA Class 3
·OL1000, OL1000 SC AND SPINALOGIC BONE GROWTH STIMULATORS
Implantable Pacemaker Pulse-Generator
FDA Pre-Market Approval
FDA Class 3
·ACTROS DR+ -B PULSE GENERATOR
Acid, Hyaluronic, Intraarticular
FDA Pre-Market Approval
FDA Class 3
·HYALGAN(R)
Implant, Cochlear
FDA Pre-Market Approval
FDA Class 3
·NUCLEUS 22 CHANNEL COCHLEAR IMPLANT
Implant, Cochlear
FDA Pre-Market Approval
FDA Class 3
·NUCLEUS 22 CHANNEL COCHLEAR IMPLANT SYSTEM
Agent, Absorbable Hemostatic, Collagen Based
FDA Pre-Market Approval
FDA Class 3
·Helistat and Helitene Absorbable Collagen Hemostatic Agent
Agent, Absorbable Hemostatic, Collagen Based
FDA Pre-Market Approval
FDA Class 3
·Collastat Absorbable Collagen Hemostatic Sponge and Collastat Absorbable Hemostatic Agent - Microfibrillar Form
Material, Dressing, Surgical, Polylactic Acid
FDA Pre-Market Approval
FDA Class 3
·CollaCote, CollaTape, and CollaPlug Absorbable Collagen Wound Dressings for Dental Surgergy
Dressing, Wound And Burn, Interactive
FDA Pre-Market Approval
FDA Class 3
·Integra Dermal Regeneration Template, Integra Meshed Dermal Regeneration Template and Integra Omnigraft Dermal Regenerat
Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Flutter
FDA Pre-Market Approval
FDA Class 3
·THERAPY COOL PATH ABLATION CATHETER
Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Flutter
FDA Pre-Market Approval
FDA Class 3
·THERAPY COOL PATH DUO ABLATION CATHETER
Intraocular Lens
FDA Pre-Market Approval
FDA Class 3
·CLARISERT PRELOADED IOL SYSTEM
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/...
Prosthesis, Ankle, Uncemented, Non-Constrained
FDA Pre-Market Approval
FDA Class 3
·Hintermann Series H3 Total Ankle Replacement System
Stimulator, Electrical, Implanted, For Parkinsonian Symptoms
FDA Pre-Market Approval
FDA Class 3
·VERCISE DEEP BRAIN STIMULATION (DBS)SYSTEM
Coronary Drug-Eluting Stent
FDA Pre-Market Approval
FDA Class 3
·XIENCE ALPINE RX & OTW EVEROLIMUS ELUTING CORONARY STENT SYSTEMS
Pulse Generator, Permanent, Implantable
FDA Pre-Market Approval
FDA Class 3
·ADVISA SR MRI A3SR01; IMPLANTABLE PULSE GENERATOR, DR MRI A2DR01 IMPLANTABLE PULSE GENERATOR, SOFTWARE MODEL 9995
Device, Angioplasty, Laser, Coronary
FDA Pre-Market Approval
FDA Class 3
·EXCIMER LASER CORONARY ATHERECTOMY (ELCA) CATHETER