6,315 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Classification: FDA Class 3
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Intraocular Lens
FDA Pre-Market Approval
FDA Class 3
·TECNIS Family of 1-piece IOLs packaged in the Daisy Wheel Configuration
Kit, Test, Alpha-Fetoprotein For Neural Tube Defects
FDA Pre-Market Approval
FDA Class 3
·ACCESS IMMUNOASSAY SYSTEMS
Implantable Pacemaker Pulse-Generator
FDA Pre-Market Approval
FDA Class 3
·AFP CARDIAC PACING SYSTEM, SENSOLOG CARDIAC PACING SYSTEM, AND SYNCHRONY CARDIAC PACING SYSTEM
Implantable Pacemaker Pulse-Generator
FDA Pre-Market Approval
FDA Class 3
·AFP CARDIAC PACING SYSTEM, SENSOLOG CARDIAC PACING SYSTEM, AND SYNCHRONY CARDIAC PACING SYSTEM
Implantable Pulse Generator, Pacemaker (Non-Crt)
FDA Pre-Market Approval
FDA Class 3
·AFP CARDIAC PACING SYSTEM, SENSOLOG CARDIAC PACING SYSTEM, AND SYNCHRONY CARDIAC PACING SYSTEM
Kit, Test, Alpha-Fetoprotein For Neural Tube Defects
FDA Pre-Market Approval
FDA Class 3
·AUTODELFIA HAFP TEST KIT
P2psa
FDA Pre-Market Approval
FDA Class 3
·ACCESS HYBRITECH P2PSA REAGENTS ON THE ACCESS IMMUNOASSAY SYSTEMS
Test, Prostate Specific Antigen, Free, (Noncomplexed) To Distinguish Prostate Cancer From Benign Conditions
FDA Pre-Market Approval
FDA Class 3
·ACCESS HYBRITECH FREE PSA REAGENTS ON THE ACCESS IMMUNOASSAY SYSTEMS
Total, Prostate Specific Antigen (Noncomplexed & Complexed) For Detection Of Prostate Cancer
FDA Pre-Market Approval
FDA Class 3
·ACCESS HYBRITECH PSA REAGENTS ON THE IMMUNOASSAY SYSTEMS
Aspiration Therapy System
FDA Pre-Market Approval
FDA Class 3
·AspireAssist
Aspiration Therapy System
FDA Pre-Market Approval
FDA Class 3
·AspireAssist
Aspiration Therapy System
FDA Pre-Market Approval
FDA Class 3
·AspireAssist
Aspiration Therapy System
FDA Pre-Market Approval
FDA Class 3
·AspireAssist
Aspiration Therapy System
FDA Pre-Market Approval
FDA Class 3
·AspireAssist
Aspiration Therapy System
FDA Pre-Market Approval
FDA Class 3
·Pathway Clinical Trial Cohort
Aspiration Therapy System
FDA Pre-Market Approval
FDA Class 3
·AspireAssist
Aspiration Therapy System
FDA Pre-Market Approval
FDA Class 3
·AspireAssist
Aspiration Therapy System
FDA Pre-Market Approval
FDA Class 3
·Aspire Assist
Aspiration Therapy System
FDA Pre-Market Approval
FDA Class 3
·AspireAssist
Aspiration Therapy System
FDA Pre-Market Approval
FDA Class 3
·AspireAssist