1,484 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
·Elecsys HBeAg
Intravascular Radiation Delivery System
FDA Pre-Market Approval
FDA Class 3
·GALILEO III INTRAVASCULAR RADIOTHERAPY SYSTEMS
Implant, Anti-Gastroesophageal Reflux
FDA Pre-Market Approval
FDA Class 3
·LINX REFLUX MANAGEMENT SYSTEM
Test, Hepatitis B (B Core, Be Antigen, Be Antibody, B Core Igm)
FDA Pre-Market Approval
FDA Class 3
·Elecsys ANti-HBs
Implant, Anti-Gastroesophageal Reflux
FDA Pre-Market Approval
FDA Class 3
·Linx Reflux Management System
Inhibitor, Peridural Fibrosis (Adhesion Barrier)
FDA Pre-Market Approval
FDA Class 3
·ADCON-L ADHESION CONTROL IN A BARRIER GEL
Intraocular Lens
FDA Pre-Market Approval
FDA Class 3
·MODIFIED J & C LOOP MODEL PA36 POSTERIOR CHAMBER INTRAOCULAR LENS
Dressing, Wound And Burn, Interactive
FDA Pre-Market Approval
FDA Class 3
·APLIGRAF(R)(GRAFTSKIN)
Stent, Coronary
FDA Pre-Market Approval
FDA Class 3
·VOYAGER NC CORONARY DILATATION CATHETER
Dressing, Wound And Burn, Interactive
FDA Pre-Market Approval
FDA Class 3
·APLIGRAF
Test, Hepatitis B (B Core, Be Antigen, Be Antibody, B Core Igm)
FDA Pre-Market Approval
FDA Class 3
·ELECSYS ANTI-HBC
Dressing, Wound And Burn, Interactive
FDA Pre-Market Approval
FDA Class 3
·APLIGRAF
Intravascular Radiation Delivery System
FDA Pre-Market Approval
FDA Class 3
·GALILEO INTRAVASCULAR RADIOTHERAPY SYSTEM
Dressing, Wound And Burn, Interactive
FDA Pre-Market Approval
FDA Class 3
·APLIGRAF (GRAFTSKIN)
Dressing, Wound And Burn, Interactive
FDA Pre-Market Approval
FDA Class 3
·APLIGRAF
Test, Hepatitis B (B Core, Be Antigen, Be Antibody, B Core Igm)
FDA Pre-Market Approval
FDA Class 3
·Elecsys Anti-HBc II / Elecsys Anti-HBc IgM
Test, Hepatitis B (B Core, Be Antigen, Be Antibody, B Core Igm)
FDA Pre-Market Approval
FDA Class 3
·ELECSYS ANTI-HBC IMMUNOASSAY ON ELECSYS 2010
Implant, Anti-Gastroesophageal Reflux
FDA Pre-Market Approval
FDA Class 3
·LINX REFLUX MANAGEMENT SYSTEM
Total, Prostate Specific Antigen (Noncomplexed & Complexed) For Detection Of Prostate Cancer
FDA Pre-Market Approval
FDA Class 3
·ELECSYS TOTAL PSA IMMUNOASSAY AND TOTAL PSA CALSET
Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Ceramic/Metal, Cemented Or Uncemented
FDA Pre-Market Approval
FDA Class 3
·OSTEO CERAMIC HIP