1,614 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Classification: FDA Class 3
×
Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Metal/Polymer, Mobile Bearing
FDA Pre-Market Approval
FDA Class 3
·LCS® Total Knee System
Stent, Coronary
FDA Pre-Market Approval
FDA Class 3
·GIANTURCO-ROUBIN CORONARY FLEX-STENT(TM) 12MM LONG
Test, Hepatitis B (B Core, Be Antigen, Be Antibody, B Core Igm)
FDA Pre-Market Approval
FDA Class 3
·Elecsys HBsAg II, Elecsys HBsAg II Auto Confirm
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, Knee, Femorotibial, Unicompartmental, Semi-Constrained, Metal/Polymer, Mobile Bearing
FDA Pre-Market Approval
FDA Class 3
·Oxford Partial Knee System
Prosthesis, Hip, Semi-Constrained, Ceramic-On-Metal Articulation
FDA Pre-Market Approval
FDA Class 3
·PINNACLE COMPLETE ACETABULAR HIP SYSTEM
Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Metal/Polymer, Mobile Bearing
FDA Pre-Market Approval
FDA Class 3
·ZIMMER NEXGEN LPS-FLEX MOBILE AND LPS-MOBILE BEARING KNEE
Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Ceramic/Metal, Cemented Or Uncemented
FDA Pre-Market Approval
FDA Class 3
·CERAMAX Ceramic Total Hip System
Test, Prostate Specific Antigen, Free, (Noncomplexed) To Distinguish Prostate Cancer From Benign Conditions
FDA Pre-Market Approval
FDA Class 3
·ELECSYS FREE PSA IMMUNOASSAY
Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Metal/Polymer, Mobile Bearing
FDA Pre-Market Approval
FDA Class 3
·LCS TOTAL KNEE SYSTEM
Test, Hepatitis B (B Core, Be Antigen, Be Antibody, B Core Igm)
FDA Pre-Market Approval
FDA Class 3
·Elecsys Anti-HBc Immunoassay
Prosthesis, Knee, Femorotibial, Unicompartmental, Semi-Constrained, Metal/Polymer, Mobile Bearing
FDA Pre-Market Approval
FDA Class 3
·Oxford Partial Knee System- Meniscal bearings
Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Metal/Polymer, Mobile Bearing
FDA Pre-Market Approval
FDA Class 3
·NEW JERSEY LCS(R) TOTAL KNEE SYSTEM
Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Ceramic/Metal, Cemented Or Uncemented
FDA Pre-Market Approval
FDA Class 3
·CERAMAX CERAMIC TOTAL HIP SYSTEM
Prosthesis, Knee, Femorotibial, Unicompartmental, Semi-Constrained, Metal/Polymer, Mobile Bearing
FDA Pre-Market Approval
FDA Class 3
·OXFORD MENISCAL UNICOMPARTMENTAL KNEE SYSTEM
Test, Hepatitis B (B Core, Be Antigen, Be Antibody, B Core Igm)
FDA Pre-Market Approval
FDA Class 3
·ELECSYS ANTI-HBC IMMUNOASSAY AND ELECSYS PRECICONTROL ANTI-HBC
Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Metal/Polymer, Mobile Bearing
FDA Pre-Market Approval
FDA Class 3
·NEW JERSEY LCS(R) TOTAL KNEE SYSTEM
Prosthesis, Knee, Patello/Femorotibial, Unconstrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer
FDA Pre-Market Approval
FDA Class 3
·LCS(R)TOTAL KNEE SYSTEM
Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Metal/Polymer, Mobile Bearing
FDA Pre-Market Approval
FDA Class 3
·NEW JERSEY LCS(R) TOTAL KNEE SYSTEM
Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Metal/Polymer, Mobile Bearing
FDA Pre-Market Approval
FDA Class 3
·LCS TOTAL KNEE SYSTEM