44 results
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20ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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HEMOSIL DRVVT SCREEN & HEMOSIL DRVVT CONFIRM
FDA 510(k)
FDA Class 1
·Hematology
MIRABAY
FDA UDI
Mirabay Orthodontics Corp.·05065025111372·OPTIMAL SYMMETRY ARCHWIRE SE NiTi 012 L1 PK10
LEONE SPA
FDA UDI
LEONE SPA·08033707096900·BKT 31 INTERACTIVE SL 22
OsteoMed
FDA UDI
OSTEOMED LLC·00845694040037·PrimaLIF 12mm Chisel
CONMED
FDA Adverse Event
Malfunction
·CONMED CORPORATION·Product code LKF·January 5, 2012
CONMED
FDA Adverse Event
Malfunction
·CONMED CORPORATION·Product code LKF·January 5, 2012
IND ONE STEP FECAL OCCULT BLOOD TEST MODEL 440-10
FDA 510(k)
FDA Class 2
·Hematology
NANODUCT NEONATAL SWEAT ANALYSIS SYSTEM
FDA 510(k)
FDA Class 2
·Physical Medicine
Qualitative And Quantitative Hepatitis B Virus Antibody Assays
FDA Pre-Market Approval
FDA Class 2
·ELECSYS ANTI-HBC IGM IMMUNOASSAY AND ELECSYS PRECICONTROL ANTI-HBC IGM
PALAXPRESS, CLEAR, 1000G POWDER
FDA Adverse Event
Injury
·HERAEUS KULZER GMBH & CO. KG, MEDICAL DIVISION·Product code EBI·February 1, 2012
MULTIFUNCTION INSTRUMENT SYSTEM (STRAIGHT GRIP HANDLE)
FDA Adverse Event
Malfunction
·CONMED CORP·Product code GEI·December 6, 2001
Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen)
FDA Pre-Market Approval
FDA Class 2
·Elecsys Anti-HBc IgM
Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen)
FDA Pre-Market Approval
FDA Class 2
·Elecsys Anti-HBc IgM, PreciControl Anti-HBc IgM
Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen)
FDA Pre-Market Approval
FDA Class 2
·ELECSYS ANTI-HBC IGM IMMUNOASSAY AND ELECSYS PRECICONTROL ANTI-HBC IGM
Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen)
FDA Pre-Market Approval
FDA Class 2
·ELECSYS ANTI-HBC-IGM ON COBAS E 411
Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen)
FDA Pre-Market Approval
FDA Class 2
·Elecsys Anti-HBc IgM
Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen)
FDA Pre-Market Approval
FDA Class 2
·ELECSYS ANTI-HBC-IGM ON COBAS E 411
Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen)
FDA Pre-Market Approval
FDA Class 2
·ELECSYS ANTI-HBC-IGM ON COBAS E 411
Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen)
FDA Pre-Market Approval
FDA Class 2
·Elecsys Anti-HBc IgM Immunoassay
Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen)
FDA Pre-Market Approval
FDA Class 2
·Elecsys Anti-HBc IgM