3,100 results
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20ms
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Sources: EU EUDAMED, US FDA
Filters
Classification: FDA Class 3
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Implantable Pulse Generator, Pacemaker (Non-Crt)
FDA Pre-Market Approval
FDA Class 3
·VARIOUS FAMILIES OF PACEMAKERS
Lenses, Soft Contact, Extended Wear
FDA Pre-Market Approval
FDA Class 3
·LensCrafters Monthly, LensCrafters Monthly Modern Lifestyle, LensCrafters Monthly for Astigmatism, LensCrafters Monthly
Coronary Drug-Eluting Stent
FDA Pre-Market Approval
FDA Class 3
·TAXUS LIBERTE ATOM PACLITAXEL-ELUTING CORONARY STENT SYSTEM
Implantable Pulse Generator, Pacemaker (Non-Crt)
FDA Pre-Market Approval
FDA Class 3
·MEDTRONIC MODEL 5388 & 5348 EXTERNAL PULSE GENERATOR
Prosthesis, Spinous Process Spacer/Plate
FDA Pre-Market Approval
FDA Class 3
·COFLEX INTERLAMINAR TECHNOLOGY
Cardiac Ablation Percutaneous Catheter
FDA Pre-Market Approval
FDA Class 3
·EZ STEER THERMOCOOL CATH, EZ STEER THERMOCOOL NAV CATH NAVISTAR RMT THERMOCOOL & THERMOCOOL CATH, THERMOCOOL SMARTTOUCH
Stimulator, Spinal-Cord, Totally Implanted For Pain Relief
FDA Pre-Market Approval
FDA Class 3
·PRECISION SPINALCORD STIMULATION
System, Endovascular Graft, Aortic Aneurysm Treatment
FDA Pre-Market Approval
FDA Class 3
·Zenith Dissection Endovascular System
Temporary Non-Roller Type Right Heart Support Blood Pump
FDA Pre-Market Approval
FDA Class 3
·Impella RP, Impella RP with SmartAssist and RP Flex with SmartAssist
Lens, Intraocular, Phakic
FDA Pre-Market Approval
FDA Class 3
·STAAR SURGICAL IMPLANTABLE COLLAMER LENS (VISIAN ICL)
Stimulator, Electrical, Implantable, For Incontinence
FDA Pre-Market Approval
FDA Class 3
·INTERSTIM SYSTEM
System, Test, Her-2/Neu, Nucleic Acid Or Serum
FDA Pre-Market Approval
FDA Class 3
·HER2 FISH PHARMDX KIT
Pulse Generator, Permanent, Implantable
FDA Pre-Market Approval
FDA Class 3
·TENDRIL, TENDRIL ST, AND OPTISENSE LEADS
Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Ceramic/Metal, Cemented Or Uncemented
FDA Pre-Market Approval
FDA Class 3
·CERAMAX® Ceramic Total Hip System
Aid, Surgical, Viscoelastic
FDA Pre-Market Approval
FDA Class 3
·BIOLON 1% SODIUM HYALURONATE FOR OPHTHALMIC SURGERY
Implant, Hearing, Active, Middle Ear, Partially Implanted
FDA Pre-Market Approval
FDA Class 3
·MAXUM SYSTEM
Device, Hemostasis, Vascular
FDA Pre-Market Approval
FDA Class 3
·MYNX VASCULAR CLOSURE DEVICE
Enzyme Immunoassay, Fetal Fibronectin
FDA Pre-Market Approval
FDA Class 3
·Rapid fFN for the TLiIQ System
Lymph Node Location System During Sentinel Biopsy Procedure
FDA Pre-Market Approval
FDA Class 3
·Magtrace/and Sentimag Magnetic Localization System
Prosthesis, Breast, Noninflatable, Internal, Silicone Gel-Filled
FDA Pre-Market Approval
FDA Class 3
·Sientra Silicone Gel Breast Implants