1,011 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Classification: FDA Class 3
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Test, Hepatitis B (B Core, Be Antigen, Be Antibody, B Core Igm)
FDA Pre-Market Approval
FDA Class 3
·ETI-MAK-2 PLUS ASSAY
Test, Prostate Specific Antigen, Free, (Noncomplexed) To Distinguish Prostate Cancer From Benign Conditions
FDA Pre-Market Approval
FDA Class 3
·ABBOTT ARCHITECT FREE PSA
Test, Hepatitis B (B Core, Be Antigen, Be Antibody, B Core Igm)
FDA Pre-Market Approval
FDA Class 3
·DIASORIN ETI-MAK-2 PLUS ASSAY
Test, Hepatitis B (B Core, Be Antigen, Be Antibody, B Core Igm)
FDA Pre-Market Approval
FDA Class 3
·DIASORIN HBSAG CONFIRMATORY TEST
Generator, Shock-Wave, For Pain Relief
FDA Pre-Market Approval
FDA Class 3
·HEALTHTRONICS OSSATRON
Implant, Corneal, Refractive
FDA Pre-Market Approval
FDA Class 3
·INTACS PRESCRIPTION INSERTS
Generator, Shock-Wave, For Pain Relief
FDA Pre-Market Approval
FDA Class 3
·HEALTHTRONICS OSSATRON
Generator, Shock-Wave, For Pain Relief
FDA Pre-Market Approval
FDA Class 3
·HEALTHTRONICS OSSATRON
Implant, Corneal, Refractive
FDA Pre-Market Approval
FDA Class 3
·INTACS PRESCRIPTION INSERTS
Implant, Cochlear
FDA Pre-Market Approval
FDA Class 3
·CLARION DEVICE FITTING SOFTWARE (SCLIN)
Implant, Corneal, Refractive
FDA Pre-Market Approval
FDA Class 3
·INTACS® Corneal Implants
Implant, Cochlear
FDA Pre-Market Approval
FDA Class 3
·CPI SWITCH BOX
Occluder, Patent Ductus, Arteriosus
FDA Pre-Market Approval
FDA Class 3
·NIT-OCCLUD SYSTEM
Implant, Corneal, Refractive
FDA Pre-Market Approval
FDA Class 3
·INTACS PRESCRIPTION INSERTS/INTACS CORNEAL IMPLANTS
Implant, Cochlear
FDA Pre-Market Approval
FDA Class 3
·CLARION(TM) MULTI-STRATEGY COCHLEAR IMPLANT
Implant, Cochlear
FDA Pre-Market Approval
FDA Class 3
·MULTI-STRATEGY COCHLEAR IMPLANT-PLATINUM BTE SOUND PROCESSOR (ADULT)
Implant, Corneal, Refractive
FDA Pre-Market Approval
FDA Class 3
·INTACS PRESCRIPTION INSERTS
Implant, Corneal, Refractive
FDA Pre-Market Approval
FDA Class 3
·INTACS CORNEAL RING SEGMENTS
Generator, Shock-Wave, For Pain Relief
FDA Pre-Market Approval
FDA Class 3
·HEALTHTRONICS OSSATRON
Implant, Cochlear
FDA Pre-Market Approval
FDA Class 3
·CLARION(R) MULTI-STRATEGY COCHLEAR IMPLANT(ADULT) HIFOCUS ELECTRODE