417 results
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19ms
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Sources: EU EUDAMED, US FDA
Filters
Classification: FDA Class 3
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Drug-Eluting Peripheral Transluminal Angioplasty Catheter
FDA Pre-Market Approval
FDA Class 3
·LUTONIX 035 DRUG COATED BALLOON PTA CATHETER
Drug-Eluting Peripheral Transluminal Angioplasty Catheter
FDA Pre-Market Approval
FDA Class 3
·SurVeil Drug-Coated Balloon
Kit, Dna Detection, Human Papillomavirus
FDA Pre-Market Approval
FDA Class 3
·digene Hybrid Capture 2 (HC2) HPV DNA Test and digene Hybrid Capture 2 (HC2) High Risk
Test, Hepatitis B (B Core, Be Antigen, Be Antibody, B Core Igm)
FDA Pre-Market Approval
FDA Class 3
·ELECSYS ANTI-HBC IMMUNOASSAY, ELECSYS PRECICONTROL ANTI-HBC FOR USE ON THE ELECSYS 2010 IMMUNOASSAY ANALYZER
Drug-Eluting Peripheral Transluminal Angioplasty Catheter
FDA Pre-Market Approval
FDA Class 3
·Lutonix 035 DCB PTA Catheter Balloon
Test, Hepatitis B (B Core, Be Antigen, Be Antibody, B Core Igm)
FDA Pre-Market Approval
FDA Class 3
·IMMULITE® 2000 Anti-HBc IgM
Test, Hepatitis B (B Core, Be Antigen, Be Antibody, B Core Igm)
FDA Pre-Market Approval
FDA Class 3
·Atellica IM anti-HBc Total (HBcT)
Test, Hepatitis B (B Core, Be Antigen, Be Antibody, B Core Igm)
FDA Pre-Market Approval
FDA Class 3
·BIO-RAD MONOLISA ANTI-HBC EIA
Test, Hepatitis B (B Core, Be Antigen, Be Antibody, B Core Igm)
FDA Pre-Market Approval
FDA Class 3
·ARCHITECT CORE / Alinity i Anti-HBc
Test, Hepatitis B (B Core, Be Antigen, Be Antibody, B Core Igm)
FDA Pre-Market Approval
FDA Class 3
·ELECSYS ANTI-HBC ON ELECSYS 2010
Test, Hepatitis B (B Core, Be Antigen, Be Antibody, B Core Igm)
FDA Pre-Market Approval
FDA Class 3
·ARCHITECT CORE / Alinity i Anti-HBc
Test, Hepatitis B (B Core, Be Antigen, Be Antibody, B Core Igm)
FDA Pre-Market Approval
FDA Class 3
·BIO-RAD MONOLOSA ANTI-HBC EIA
Test, Hepatitis B (B Core, Be Antigen, Be Antibody, B Core Igm)
FDA Pre-Market Approval
FDA Class 3
·Elecsys Anti-HBc Immunoassay test system
Test, Hepatitis B (B Core, Be Antigen, Be Antibody, B Core Igm)
FDA Pre-Market Approval
FDA Class 3
·ELECSYS ANTI-HBC ON ELECSYS 2010
Test, Hepatitis B (B Core, Be Antigen, Be Antibody, B Core Igm)
FDA Pre-Market Approval
FDA Class 3
·ARCHITECT CORE / Alinity i Anti-HBc
Test, Hepatitis B (B Core, Be Antigen, Be Antibody, B Core Igm)
FDA Pre-Market Approval
FDA Class 3
·PRECICONTROL ANTI-HBC (MODULAR ANALYTICS E170)
Test, Hepatitis B (B Core, Be Antigen, Be Antibody, B Core Igm)
FDA Pre-Market Approval
FDA Class 3
·ARCHITECT CORE / Alinity i Anti-HBc
Test, Hepatitis B (B Core, Be Antigen, Be Antibody, B Core Igm)
FDA Pre-Market Approval
FDA Class 3
·BIO-RAD MONOLISA ANTI-HBC EIA
Test, Hepatitis B (B Core, Be Antigen, Be Antibody, B Core Igm)
FDA Pre-Market Approval
FDA Class 3
·ARCHITECT CORE / Alinity i Anti-HBc
Test, Hepatitis B (B Core, Be Antigen, Be Antibody, B Core Igm)
FDA Pre-Market Approval
FDA Class 3
·ELECSYS ANTI-HBC IGM TEST SYSTEM