7 results
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27ms
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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 HBsAg II (100/200 tests)
Total, Prostate Specific Antigen (Noncomplexed & Complexed) For Detection Of Prostate Cancer
FDA Pre-Market Approval
FDA Class 3
·Elecsys total PSA (100/200 tests) Immunoassay
Test, Hepatitis B (B Core, Be Antigen, Be Antibody, B Core Igm)
FDA Pre-Market Approval
FDA Class 3
·Elecsys HBsAg II (100/200 tests) Immunoassay
MAESTRO(R) SERIES 100/200 SINGLE CHAMBER PACEMAKER
FDA 510(k)
FDA Class 3
·Cardiovascular
CCS IMPLANTABLE MAESTRO(R) SERIES 100/200 PACEMAK.
FDA 510(k)
FDA Class 3
·Cardiovascular
MAESTRO SERIES 100/200 CARDIAC SINGLE CHAMBER PACE
FDA 510(k)
FDA Class 3
·Cardiovascular
MAESTRO(R) SERIES 100/200 CARDIAC S/CHAMB PACEMAKE
FDA 510(k)
FDA Class 3
·Cardiovascular