3,169 results
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27ms
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Sources: EU EUDAMED, US FDA
Filters
Classification: FDA Class 3
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Prosthesis, Hip, Semi-Constrained, Metal/Metal, Resurfacing
FDA Pre-Market Approval
FDA Class 3
·CORMET HIP RESURFACING SYSTEM
System, Esophageal Pacing
FDA Pre-Market Approval
FDA Class 3
·STAT PACE II
Implanted Brain Stimulator For Epilepsy
FDA Pre-Market Approval
FDA Class 3
·NEURO PACE RNS SYSTEM
Kit, Dna Detection, Human Papillomavirus
FDA Pre-Market Approval
FDA Class 3
·COBAS HPV TEST
Defibrillator, Automatic Implantable Cardioverter, With Cardiac Resynchronization (Crt-D)
FDA Pre-Market Approval
FDA Class 3
·MANAGE HF Study
Permanent Defibrillator Electrodes
FDA Pre-Market Approval
FDA Class 3
·Sprint Quattro Secure S MRI SureScan Lead and Sprint Quattro Secure MRI SureScan Lead
Implant, Cochlear
FDA Pre-Market Approval
FDA Class 3
·Neuro Cochlear Implant System
Stimulator, Electrical, Implanted, For Parkinsonian Tremor
FDA Pre-Market Approval
FDA Class 3
·Infinity Family of Implantable Pulse Generators
Somatic Gene Mutation Detection System
FDA Pre-Market Approval
FDA Class 3
·therascreen FGFR RGQ PCR Kit
Implantable Pulse Generator, Pacemaker (Non-Crt)
FDA Pre-Market Approval
FDA Class 3
·The Tendril MRI lead
Implant, Dermal, For Aesthetic Use
FDA Pre-Market Approval
FDA Class 3
·Restylane® Eyelight Injectable Gel
Bronchial Thermoplasty System
FDA Pre-Market Approval
FDA Class 3
·ALAIR BRONCHIAL THERMOPLASTY SYSTEM
Prosthesis, Breast, Noninflatable, Internal, Silicone Gel-Filled
FDA Pre-Market Approval
FDA Class 3
·MEMORYGEL SILICONE GEL-FILLED BREAST IMPLANTS
System, Imaging, Fluorescence
FDA Pre-Market Approval
FDA Class 3
·PINPOINT ENDOSCOPIC LIGHT SOURCE AND VIDEO CAMERA
Lens, Multifocal Intraocular
FDA Pre-Market Approval
FDA Class 3
·ACRYSOF RESTOR IQ IOL
Heart-Valve, Non-Allograft Tissue
FDA Pre-Market Approval
FDA Class 3
·INSPIRIS RESILIA Aortic Valve, KONECT RESILIA Aortic Valve Conduit (AVC), MITRIS RESILIA Mitral Valve
Stent, Superficial Femoral Artery
FDA Pre-Market Approval
FDA Class 3
·SUPERA PERIPHERAL STENT SYSTEM
Defibrillator, Implantable, Dual-Chamber
FDA Pre-Market Approval
FDA Class 3
·OVATIO DR & OVATIO VR ICDS
Implant, Dermal, For Aesthetic Use
FDA Pre-Market Approval
FDA Class 3
·ELEVESS (AKA COSMETIC TISSUE AUGMENTATION PRODUCT)
Pulse Generator, Permanent, Implantable
FDA Pre-Market Approval
FDA Class 3
·Advisa DR MRI SureScan Model A2DR01 IPG, Advisa SR MRI SureScan Model A3SR01 IPG