47 results
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18ms
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Sources: EU EUDAMED, US FDA
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FDA Enforcement
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COVIDIEN Shiley Tracheostomy Tube Cuffed with Inner Cannula REF 6FEN UDI-DI code: 60884522007028 The devices are intended for use in providing tracheal access for airway management. Shiley Tracheostomy Tubes are double cannula tracheostomy tubes with reusable inner cannulae (LPC, FEN, CFS, CFN, LGT) and twist-lock connectors. These Shiley Tracheostomy Tubes have a radiopaque, biocompatible outer cannula constructed of polyvinyl chloride.
FDA Enforcement
Class II
·Ongoing·Covidien LLC·June 10, 2026
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
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
Preformed AGT Oral Endotracheal Tube uncuffed/plain - Murphy, REF 100181040
FDA Enforcement
Class I
·Ongoing·TELEFLEX LLC·July 5, 2023
Preformed AGT Oral Endotracheal Tube uncuffed/plain - Murphy, REF 100181055
FDA Enforcement
Class I
·Ongoing·TELEFLEX LLC·July 5, 2023