485 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Classification: FDA Class 3
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Kit, Test, Alpha-Fetoprotein For Neural Tube Defects
FDA Pre-Market Approval
FDA Class 3
·ACCESS AFP REAGENTS ON THE ACCESS IMMUNOASSAY SYSTEMS
Kit, Test, Alpha-Fetoprotein For Neural Tube Defects
FDA Pre-Market Approval
FDA Class 3
·ACCESS AFP REAGENTS ON THE ACCESS IMMUNOASSAY SYSTEMS
Kit, Test, Alpha-Fetoprotein For Neural Tube Defects
FDA Pre-Market Approval
FDA Class 3
·IMMULITE, IMMULITE 1000, IMMULITE 2000, and IMMULITE 2500 AFP
Reader, Cervical Cytology Slide, Automated
FDA Pre-Market Approval
FDA Class 3
·AUTOPAP(R) 300 QC AUTOMATIC PAP SCREENER/QC SYSTEM
Reader, Cervical Cytology Slide, Automated
FDA Pre-Market Approval
FDA Class 3
·AUTOPAP(R) 300 QC AUTOMATIC PAP SCREENER/QC SYSTEM
Reader, Cervical Cytology Slide, Automated
FDA Pre-Market Approval
FDA Class 3
·AUTOPAP(R) 300 QC AUTOMATIC PAP SCREENER/QC SYSTEM
Implantable Pulse Generator, Pacemaker (Non-Crt)
FDA Pre-Market Approval
FDA Class 3
·AFP CARDIAC PACING SYS. MODEL 385 G FUNCTION PACK
Reader, Cervical Cytology Slide, Automated
FDA Pre-Market Approval
FDA Class 3
·AUTOPAP(R) 300 QC AUTOMATIC PAP SCREENER/QC SYSTEM
Kit, Test, Alpha-Fetoprotein For Neural Tube Defects
FDA Pre-Market Approval
FDA Class 3
·IN VITRO DIAGNOSTIC PRODUCT ACCESS AFP REAGENTS ON THE ACCESS IMMUNOASSAY SYSTEMS
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
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
·Fluency® Plus Endovascular Stent Graft
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
·FLAIR ENDOVASCULAR STENT GRAFT
System, Endovascular Graft, Arteriovenous (Av) Dialysis Access Circuit Stenosis Treatment
FDA Pre-Market Approval
FDA Class 3
·BARD FLAIR ENDOVASCULAR STENT GRAFT
System, Endovascular Graft, Arteriovenous (Av) Dialysis Access Circuit Stenosis Treatment
FDA Pre-Market Approval
FDA Class 3
·Fluency Endovascular Stent Graft