4,919 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Classification: FDA Class 3
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Lens, Multifocal Intraocular
FDA Pre-Market Approval
FDA Class 3
·ACRYSOF RESTOR INTRAOCULAR LENSES
Pulse Generator, Permanent, Implantable
FDA Pre-Market Approval
FDA Class 3
·KAPPA 600/700/650/800/900 IPGS/ENPULSE/SIGMA/MEDTRONIC 350 SERIES/AT500/ENRHYTHM/ADAPTA/VERSA/SENSIA/RELIA IPGS
Agent, Bulking, Injectable For Gastro-Urology Use
FDA Pre-Market Approval
FDA Class 3
·DURASPHERE INJECTABLE BULKING AGENT
Implantable Pulse Generator, Pacemaker (Non-Crt)
FDA Pre-Market Approval
FDA Class 3
·CAPSUREFIX MRI SURESCAN LEAD
Implantable Pulse Generator, Pacemaker (Non-Crt)
FDA Pre-Market Approval
FDA Class 3
·ATTAIN BIPOLAR OTW/OTW/CS LEAD
Catheter, Coronary, Atherectomy
FDA Pre-Market Approval
FDA Class 3
·Rotablatorand ROTAPRO Rotational Atherectomy System, RotaWire Guidewire and wireClip Torquer, ROTAWIRE Drive Guidew
Permanent Defibrillator Electrodes
FDA Pre-Market Approval
FDA Class 3
·LEAD ASSEMBLY
Hepatitis Viral B Dna Detection
FDA Pre-Market Approval
FDA Class 3
·Cobas HBV
System, Test, Her-2/Neu, Ihc
FDA Pre-Market Approval
FDA Class 3
·BOND Oracle HER2 IHC System
Occluder, Patent Ductus, Arteriosus
FDA Pre-Market Approval
FDA Class 3
·AMPLATZER MULTI-FENESTRATED SEPTAL OCCULDER (CRIBRIFORM)
Pulse Generator, Permanent, Implantable
FDA Pre-Market Approval
FDA Class 3
·ADAPTA, VERSA, SENSIA IPG, RELIA IPG
Heart-Valve, Non-Allograft Tissue
FDA Pre-Market Approval
FDA Class 3
·MOSIAC PORCINE BIOPROSTHESIS
Implant, Cochlear
FDA Pre-Market Approval
FDA Class 3
·NUCLEUS CI500 SERIES COCHLEAR IMPLANT SYSTEM
Drug Eluting Permanent Right Ventricular (Rv) Or Right Atrial (Ra) Pacemaker Electrodes
FDA Pre-Market Approval
FDA Class 3
·CapSure Sense Lead 4074, 4574; CapSure SP Novus Lead 4092, 4592
Heart-Valve, Non-Allograft Tissue
FDA Pre-Market Approval
FDA Class 3
·Freestyle Aortic Root Bioprosthesis
Agent, Bulking, Injectable For Gastro-Urology Use
FDA Pre-Market Approval
FDA Class 3
·DURASPHERE INJECTABLE BULKING AGENT
Pulse Generator, Permanent, Implantable
FDA Pre-Market Approval
FDA Class 3
·KAPPA 600/700/650/800/900/RELIA/SIGMA/MEDTRONIC 350/ENPULSE/ENRHYTHM/AT500/ADAPTA/VERSA/SENSIA IPGS
Implant, Cochlear
FDA Pre-Market Approval
FDA Class 3
·NUCLEUS 24 COCHLEAR IMPLANT SYSTEM
Drug Eluting Permanent Left Ventricular (Lv) Pacemaker Electrode
FDA Pre-Market Approval
FDA Class 3
·INSYNC CRT-P/INSYNC III CRT-P
Replacement Heart-Valve
FDA Pre-Market Approval
FDA Class 3
·CARPENTIER-EDWARDS PORCINE AORTIC AND MITRAL BIOPROSTHESES