1,222 results
·
7ms
·
Sources: EU EUDAMED, US FDA
Filters
Classification: FDA Class 2
×
ABB VIE J
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
BONEBRIDGE System, SAMBA 2 BB, SYMFIT 8.0, SAMBA 2 GO, SAMBA 2 Remote
FDA 510(k)
FDA Class 2
·Ear, Nose, Throat
ß-Glucocerebrosidase (Gba) Newborn Screening Test System
FDA classification
FDA Class 2
·ß-Glucocerebrosidase (Gba) Newborn Screening Test System
Broncho Videoscope System (Single-use Broncho Videoscope (SBV-1A-B, SBV-1A-P, SBV-1B-B, SBV-1B-P, SBV-1C-B, SBV-1C-P); Full HD Visualization Endoscopic Image Processor (HDVS-S300A, HDVS-S300B, HDVS-S300C, HDVS-S300D); Endoscopic Image Processor (HDVS-S100A, HDVS-S100D))
FDA 510(k)
FDA Class 2
·Ear, Nose, Throat
Urology Videoscope System (Single-use Flexible Ureteroscope: SUV-1A-B, SUV-1A-P, SUV-2A-B, SUV-2A-P, SUV-2B-B, SUB-2B-P, SUV-2C-B, SUV-2C-P;Single-use Flexible Cystoscope: SUV-1D-B, SUV-1D-P; Endoscopic Image Processor: HDVS-S100A, HDVS-S100D.)
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
Devices, Measure, Antibodies To Glomerular Basement Membrane (Gbm)
FDA classification
FDA Class 2
·Devices, Measure, Antibodies To Glomerular Basement Membrane (Gbm)
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
Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen)
FDA Pre-Market Approval
FDA Class 2
·LIAISON® XL MUREX HBsAg Qual assay and Control
Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen)
FDA Pre-Market Approval
FDA Class 2
·AXSYM CORE-M 2.0 AND AXSYM CORE-M 2.0 CONTROLS
Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen)
FDA Pre-Market Approval
FDA Class 2
·ADVIA CENTAUR HBSAGII