137 results
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11ms
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Sources: EU EUDAMED, US FDA
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Status: Ongoing
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Atellica Gamma-Glutamyl Transferase (GGT) Reagent - Product Usage: For in vitro diagnostic use in the quantitative determination of gamma-glutamyl transferase in human serum and plasma. Siemens Material Number (SMN): 11097597
FDA Enforcement
Class II
·Ongoing·Siemens Healthcare Diagnostics, Inc.·December 30, 2020
ADVIA Gamma-Glutamyl Transferase (GGT) Reagent - Product Usage: For in vitro diagnostic use in the quantitative determination of gamma-glutamyl transferase in human serum and plasma. Siemens Material Number (SMN): ADVIA Chemistry: 10309495 (20 mL) 10316298 (70 mL)
FDA Enforcement
Class II
·Ongoing·Siemens Healthcare Diagnostics, Inc.·December 30, 2020
Atellica CH Gamma-Glutamyl Transferase-IIn vitro diagnostic use in the quantitative determination of gamma-glutamyl transferase in human serum and plasma (lithium heparin Test Code: GGT Siemens Material Number (SMN): 11097597
FDA Enforcement
Class II
·Ongoing·Siemens Healthcare Diagnostics, Inc.·September 6, 2023
Atellica CH Total Bilirubin_2 -In vitro diagnostic use in the quantitative determination of total bilirubin in human serum and plasma (lithium heparin) of adults and neonates Test Code: TBil_2 Siemens Material Number (SMN): 11097531
FDA Enforcement
Class II
·Ongoing·Siemens Healthcare Diagnostics, Inc.·September 6, 2023
Atellica¿ CH HDL Cholesterol- In vitro diagnostic use in the quantitative determination of HDL cholesterol in human serum and plasma (lithium heparin, EDTA, sodium Heparin) Test Code: HDLC Siemens Material Number (SMN): 11537213
FDA Enforcement
Class II
·Ongoing·Siemens Healthcare Diagnostics, Inc.·September 6, 2023
Atellica CH LDL Cholesterol- In vitro diagnostic use in the quantitative determination of LDL cholesterol in human serum and plasma (lithium heparin, EDTA, sodium heparin Test Code: LDLC Siemens Material Number (SMN): 11537214
FDA Enforcement
Class II
·Ongoing·Siemens Healthcare Diagnostics, Inc.·September 6, 2023
DVOT SARS-CoV-2 ANTIGEN TEST KIT, Model Number FCY-AGT-01
FDA Enforcement
Class II
·Ongoing·FENG CHUN YUAN MEDICAL EQUIPMENT (SHENZHEN)CO.,LTD·October 9, 2024
Preformed AGT Oral Endotracheal Tube Murphy Eye, High Volume, Low Pressure Cuff, REF 111780090
FDA Enforcement
Class I
·Ongoing·TELEFLEX LLC·July 5, 2023
Preformed AGT Oral Endotracheal Tube uncuffed/plain - Murphy, REF 100180070
FDA Enforcement
Class I
·Ongoing·TELEFLEX LLC·July 5, 2023
Preformed AGT Oral Endotracheal Tube Murphy Eye, High Volume, Low Pressure Cuff, REF 111780085
FDA Enforcement
Class I
·Ongoing·TELEFLEX LLC·July 5, 2023
Preformed AGT Oral Endotracheal Tube uncuffed/plain - Murphy, REF 100181030
FDA Enforcement
Class I
·Ongoing·TELEFLEX LLC·July 5, 2023
Preformed AGT Oral Endotracheal Tube uncuffed/plain - Murphy, REF 100180065
FDA Enforcement
Class I
·Ongoing·TELEFLEX LLC·July 5, 2023
Preformed AGT Oral Endotracheal Tube uncuffed/plain - Murphy, REF 100181065
FDA Enforcement
Class I
·Ongoing·TELEFLEX LLC·July 5, 2023
Preformed AGT Oral Endotracheal Tube uncuffed/plain - Murphy, REF 100180060
FDA Enforcement
Class I
·Ongoing·TELEFLEX LLC·July 5, 2023
Preformed AGT Oral Endotracheal Tube uncuffed/plain - Murphy, REF 100180040
FDA Enforcement
Class I
·Ongoing·TELEFLEX LLC·July 5, 2023
Preformed AGT Oral Endotracheal Tube uncuffed/plain - Murphy, REF 100181060
FDA Enforcement
Class I
·Ongoing·TELEFLEX LLC·July 5, 2023
Preformed AGT Oral Endotracheal Tube uncuffed/plain - Murphy, REF 100180050
FDA Enforcement
Class I
·Ongoing·TELEFLEX LLC·July 5, 2023
Preformed AGT Oral Endotracheal Tube uncuffed/plain - Murphy, REF 100180055
FDA Enforcement
Class I
·Ongoing·TELEFLEX LLC·July 5, 2023
Preformed AGT Oral Endotracheal Tube uncuffed/plain - Murphy, REF 100180030
FDA Enforcement
Class I
·Ongoing·TELEFLEX LLC·July 5, 2023
Preformed AGT Oral Endotracheal Tube uncuffed/plain - Murphy, REF 100180035
FDA Enforcement
Class I
·Ongoing·TELEFLEX LLC·July 5, 2023