360 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
·VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HBC IGM REAGENT PACK & CALIBRATORS
Test, Hepatitis B (B Core, Be Antigen, Be Antibody, B Core Igm)
FDA Pre-Market Approval
FDA Class 3
·VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HBC IGM REAGENT PACK & CALIBRATOR
Test, Hepatitis B (B Core, Be Antigen, Be Antibody, B Core Igm)
FDA Pre-Market Approval
FDA Class 3
·ELECSYS ANTI-HBC IMMUNOASSAY ON THE ELECSYS 2010 IMMUNOASSAY ANALYZER
Test, Hepatitis B (B Core, Be Antigen, Be Antibody, B Core Igm)
FDA Pre-Market Approval
FDA Class 3
·VITROS IMMUNODIAGNOSTICS PRODUCTS ANTI-HBC IGM REAGENT PACK AND CALIBRATORS
POWRPAK REPLACEMENT BATTERIES FOR PHISIO-CONTROL LIFEPAK 5/10
FDA 510(k)
FDA Class 3
·Cardiovascular
Test, Hepatitis B (B Core, Be Antigen, Be Antibody, B Core Igm)
FDA Pre-Market Approval
FDA Class 3
·ELECSYS ANTI-HBC IMMUNOASSAY ON THE MODULAR ANALYSTICS E170 IMMUNOASSAY ANALYZER
Test, Hepatitis B (B Core, Be Antigen, Be Antibody, B Core Igm)
FDA Pre-Market Approval
FDA Class 3
·IMMULITE, IMMULITE 1000 ANTI-HBC IGM AND IMMULITE 2000 ANTI-HBCIGM
Intraocular Lens
FDA Pre-Market Approval
FDA Class 3
·Softec HD/ HD PS, Softec I, Softec HDO, Softec HDM IOLs
Intraocular Lens
FDA Pre-Market Approval
FDA Class 3
·Softec HD, Sotlec I, Softec HD PS, Softec HDO, Softec HDM
Intraocular Lens
FDA Pre-Market Approval
FDA Class 3
·HQL Softec HD, Softec I, Softec HD PS, Softec HDO, Softec HDM
Test, Hepatitis B (B Core, Be Antigen, Be Antibody, B Core Igm)
FDA Pre-Market Approval
FDA Class 3
·ARCHITECT CORE-M Reagent Kit, Alinity i Anti-HBc IgM Reagent Kit
Test, Hepatitis B (B Core, Be Antigen, Be Antibody, B Core Igm)
FDA Pre-Market Approval
FDA Class 3
·ARCHITECT CORE-M Reagent Kit, Alinity i Anti-HBc IgM Reagent Kit
Intraocular Lens
FDA Pre-Market Approval
FDA Class 3
·Softec HD, Softec I, Softec HD PS, Softec HDO, and Softec HDM IOLs
Intraocular Lens
FDA Pre-Market Approval
FDA Class 3
·Softec HD, Softec I, Softec HD PS, Softec HDO, and Softec HDM IOLs
Intraocular Lens
FDA Pre-Market Approval
FDA Class 3
·Softec HD, Softec I, Softec HD PS, Softec HDO, and Softec HDM IOLs
Test, Hepatitis B (B Core, Be Antigen, Be Antibody, B Core Igm)
FDA Pre-Market Approval
FDA Class 3
·ADVIA Centaur Anti-HBc Total 2 (HBcT2), ADVIA Centaur® HBcT2 Quality Control (HBcT2 QC)
MEDILAS 2
FDA 510(k)
FDA Class 3
·Unknown
NOVATHERM
FDA 510(k)
FDA Class 3
·Obstetrics/Gynecology
OSCOR MEDICAL IMPLANTABLE PACING LEAD, RETRACTABLE
FDA 510(k)
FDA Class 3
·Cardiovascular
MULTI-FUNCTION DEFIBRILLATION ELECTRODE
FDA 510(k)
FDA Class 3
·Cardiovascular