591 results
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33ms
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Sources: EU EUDAMED, US FDA
Filters
Classification: FDA Class 3
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Antigen(Complexed),Prostate Specific,(Cpsa)
FDA Pre-Market Approval
FDA Class 3
·COMPLEXED PSA MICROTITER ELISA
Antigen(Complexed),Prostate Specific,(Cpsa)
FDA Pre-Market Approval
FDA Class 3
·IMMUNO 1 COMPLEXED PSA ASSAY
Antigen(Complexed),Prostate Specific,(Cpsa)
FDA Pre-Market Approval
FDA Class 3
·ADVIA Centaur cPSA Readypack Reagents
Lens, Intraocular, Accommodative
FDA Pre-Market Approval
FDA Class 3
·CRYSTALENS MODEL AT-45 ACCOMMODATING INTRAOCULAR LENS
Antigen(Complexed),Prostate Specific,(Cpsa)
FDA Pre-Market Approval
FDA Class 3
·ACS: 180 AND ADVIA CENTAUR COMPLEXED PSA (CPSA) IMMUNOASSAYS
Lens, Intraocular, Accommodative
FDA Pre-Market Approval
FDA Class 3
·CRYSTALENS MODEL AT-45 ACCOMMODATING INTRAOCULAR LENS
Lens, Intraocular, Accommodative
FDA Pre-Market Approval
FDA Class 3
·CRYSTALENS MODEL AT-45 ACCOMMODATING INTRAOCULAR LENS
Antigen(Complexed),Prostate Specific,(Cpsa)
FDA Pre-Market Approval
FDA Class 3
·Atellica IM Complexed PSA (cPSA)
Antigen(Complexed),Prostate Specific,(Cpsa)
FDA Pre-Market Approval
FDA Class 3
·ACS:180 & ADVIA CENTAUR CPSA IMMUNOASSAYS
Total, Prostate Specific Antigen (Noncomplexed & Complexed) For Detection Of Prostate Cancer
FDA Pre-Market Approval
FDA Class 3
·DIMENSION VISTA TPSA FLEX REAGENT CARTRIDGE
Replacement Heart-Valve
FDA Pre-Market Approval
FDA Class 3
·Carpentier-Edwards PERIMOUNT Magna Ease Pericardial Aortic Bioprosthesis, Model 3300TFX
Prosthesis, Penis, Inflatable
FDA Pre-Market Approval
FDA Class 3
·MAS 700 Inflatable Penile PRosthesis (IP) with and without InhibiZone
ZP9141, ZP9146Y, ZP9146W NON-RECHARGEABLE BATTERY
FDA 510(k)
FDA Class 3
·Cardiovascular
Replacement Heart-Valve
FDA Pre-Market Approval
FDA Class 3
·CARPENTIER-EDWARDS PERIMOUNT MAGNA EASE MITRAL BIOPROSTHESES, MODELS 7100 AND 7100TFX
Replacement Heart-Valve
FDA Pre-Market Approval
FDA Class 3
·Carpentier-Edwards PERIMOUNT Magna Ease Pericardial Aortic Bioprosthesis with ThermaFix tissue process
Replacement Heart-Valve
FDA Pre-Market Approval
FDA Class 3
·CARPENTIER-EDWARDS PERIMOUNT MAGNA MITRAL EASE PERICARDIAL BIOPROSTHESIS WITH THERMAFIX TISSUE PROCESS
Replacement Heart-Valve
FDA Pre-Market Approval
FDA Class 3
·CAPENTIER-EDWARDS PERIMOUNT THEON, THEON PSR, MAGNA, MAGNA EASE, PERICARDIAL AORTIC BIOPROSTHESIS
Replacement Heart-Valve
FDA Pre-Market Approval
FDA Class 3
·CAPENTIER-EDWARDS PERIMOUNT THEON, THEON PSR, MAGNA, MAGNA EASE, PERICARDIAL AORTIC BIOPROSTHESIS
Replacement Heart-Valve
FDA Pre-Market Approval
FDA Class 3
·Carpentier-Edwards PERIMOUNT Magna Ease Pericardial Aortic Bioprosthesis with ThermaFix tissue process
Replacement Heart-Valve
FDA Pre-Market Approval
FDA Class 3
·CARPENTIER-EDWARDS PERIMOUNT MAGNA MITRAL EASE PERCARDIAL BIOPRSTHESIS MODELS 7300 AND 7300TFX