1,227 results
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17ms
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Sources: EU EUDAMED, US FDA
IBED WIRELESS WITH IBED AWARENESS
FDA 510(k)
FDA Class 2
·General Hospital
iBed Wireless with iBed Mobile
FDA 510(k)
FDA Class 2
·General Hospital
Second Opinion® BLE
FDA 510(k)
FDA Class 2
·Radiology
BLE Smart Blood Glucose Monitoring System, BLE Smart Professional Blood Glucose Monitoring System
FDA 510(k)
FDA Class 2
·Clinical Chemistry
MDT2 BLE Self-Monitoring Blood Glucose System
FDA 510(k)
FDA Class 2
·Clinical Chemistry
uwe sun tanning beds/booths P90, iBED EVG, iSUN HP, SILVERBULLET SE, LOTUS
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
GlucoDr.S Blood Glucose Monitoring System, GlucoDr.S BLE Blood Glucose Monitoring System, GlucoDr.S NFC Blood Glucose Monitoring System
FDA 510(k)
FDA Class 2
·Clinical Chemistry
Coating, Denture Hydrophilic, Resin
FDA classification
FDA Class 2
·Coating, Denture Hydrophilic, Resin
Antismooth Muscle Antibody, Indirect Immunofluorescent, Antigen, Control
FDA classification
FDA Class 2
·Antismooth Muscle Antibody, Indirect Immunofluorescent, Antigen, Control
Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen)
FDA Pre-Market Approval
FDA Class 2
·ETI-EBK PLUS
Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen)
FDA Pre-Market Approval
FDA Class 2
·VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HBC IGM REAGENT PACK AND CALIBRATOR
Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen)
FDA Pre-Market Approval
FDA Class 2
·VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HBC IGM ASSAY
Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen)
FDA Pre-Market Approval
FDA Class 2
·LIAISON® XL MUREX Anti-HBc and LIAISON® XL MUREX Control Anti-HBc
Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen)
FDA Pre-Market Approval
FDA Class 2
·Vitros Immunodiagnostic Products Anti-HBe Reagent Pack and Calibrator
Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen)
FDA Pre-Market Approval
FDA Class 2
·IMMULITE 2000 Anti HBc IgM
Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen)
FDA Pre-Market Approval
FDA Class 2
·Atellica® IM Anti-Hepatitis B surface Antigen 2 (aHBs2) Assay
Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen)
FDA Pre-Market Approval
FDA Class 2
·ELECSCYS HBSAG IMMUNOASSAY, ELECSYS PRECICONTROL HBSAG, ELECSYS HBSAG CONFIRMATORY TEST
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-HBS IMMUNOASSAY
Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen)
FDA Pre-Market Approval
FDA Class 2
·ARCHITECT AUSAB / Alinity i Anti-HBs