334 results
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18ms
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Sources: EU EUDAMED, US FDA
Filters
Classification: FDA Class 3
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Sealant, Dural
FDA Pre-Market Approval
FDA Class 3
·DURASEAL EXACT SPINE SEALANT SYSTEM
Prosthesis, Knee, Femorotibial, Unicompartmental, Semi-Constrained, Metal/Polymer, Mobile Bearing
FDA Pre-Market Approval
FDA Class 3
·OXFORD MENISCAL UNICOMPARTMENTAL KNEE
Sealant, Polymerizing
FDA Pre-Market Approval
FDA Class 3
·Progel Pleural Air Leak Sealant
Prosthesis, Knee, Femorotibial, Unicompartmental, Semi-Constrained, Metal/Polymer, Mobile Bearing
FDA Pre-Market Approval
FDA Class 3
·Oxford Partial Knee
Sealant, Polymerizing
FDA Pre-Market Approval
FDA Class 3
·PROGEL Pleural Air Leak Sealant
Sealant, Polymerizing
FDA Pre-Market Approval
FDA Class 3
·TRIDYNE Vascular Sealant
Prosthesis, Knee, Femorotibial, Unicompartmental, Semi-Constrained, Metal/Polymer, Mobile Bearing
FDA Pre-Market Approval
FDA Class 3
·Oxford Partial Knee System
Prosthesis, Knee, Femorotibial, Unicompartmental, Semi-Constrained, Metal/Polymer, Mobile Bearing
FDA Pre-Market Approval
FDA Class 3
·Oxford® Partial Knee System
Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Metal/Polymer, Mobile Bearing
FDA Pre-Market Approval
FDA Class 3
·LCS TOTAL KNEE SYSTEM
Somatic Gene Mutation Detection System
FDA Pre-Market Approval
FDA Class 3
·ROCHE COBAS KRAS MUTATION TEST, ROCHE COBAS DNA SAMPLE PREPARATION KIT
Laparoscopic Contraceptive Tubal Occlusion Device
FDA Pre-Market Approval
FDA Class 3
·DISPOSABLE FALOPE-RING BAND APPLICATOR KITS
Laparoscopic Contraceptive Tubal Occlusion Device
FDA Pre-Market Approval
FDA Class 3
·DISPOSABLE FALOPE-RING BANK APPLICATOR KITS
Prosthesis, Knee, Patello/Femorotibial, Unconstrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer
FDA Pre-Market Approval
FDA Class 3
·NEW JERSEY LCS(R) UNICOMPARTMENTAL KNEE
HEARTSTART 1000S
FDA 510(k)
FDA Class 3
·Cardiovascular
HEARTSTART 1000
FDA 510(k)
FDA Class 3
·Cardiovascular
Coronary Drug-Eluting Stent
FDA Pre-Market Approval
FDA Class 3
·RESOLUTE INTEGRITY ZOTAROLIMUS-ELUTING CORONARY STENT SYSTEM
Implanted Brain Stimulator For Epilepsy
FDA Pre-Market Approval
FDA Class 3
·NEUROPACE RNS SYSTEM
Implanted Brain Stimulator For Epilepsy
FDA Pre-Market Approval
FDA Class 3
·NeuroPace RNS System
System, Endovascular Graft, Arteriovenous (Av) Dialysis Access Circuit Stenosis Treatment
FDA Pre-Market Approval
FDA Class 3
·GORE® VIABAHN® Endoprosthesis, GORE® VIABAHN® Endoprosthesis with Heparin Bioactive Surface
Ophthalmic Sealant
FDA Pre-Market Approval
FDA Class 3
·RESURE SEALANT