1,377 results
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10ms
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Sources: EU EUDAMED, US FDA
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Status: Terminated
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Sekisui Diagnostics Ammonia L3K Assay; Catalog Number: 293-80-91 and 293-10 For the IN VITRO quantitative measurement of ammonia concentration in plasma
FDA Recall
Terminated
·Sekisui Diagnostics P.E.I. Inc.·Product code JIF·November 29, 2016
Dimension Ammonia (AMM) assay; (Product Number: DF119/10711991) (Mfr: Siemens Healthcare Diagnostics, Newark, DE)
FDA Recall
Terminated
·Siemens Healthcare Diagnostics, Inc.·Product code JIF·June 29, 2017
AM1054 Randox Ammonia (NH3), Enzymatic UV Method For the quantitative in vitro determination of Ammonia in plasma
FDA Recall
Terminated
·RANDOX LABORATORIES, LTD. 34 Diamond Rd Crumlin Colorado Antrim United Kingdom·Product code JIF·July 30, 2020
Dimension Vista Ammonia (AMM) assay (Product Number: K3119/10711992) (Mfr: Siemens Healthcare Diagnostics, Newark, DE)
FDA Recall
Terminated
·Siemens Healthcare Diagnostics, Inc.·Product code JIF·June 29, 2017
Dimension Ammonia Flex reagent cartridge / AMM Dimension: The AMM method is an in vitro diagnostic test for the quantitative measurement of ammonia in human plasma on the Dimension clinical chemistry system. Ammonia measurements are used in the diagnosis and treatment of severe liver disorders such as cirrhosis, hepatitis and Reye s syndrome
FDA Recall
Terminated
·Siemens Healthcare Diagnostics, Inc.·Product code JIF·December 16, 2016
SYNCHRON Ammonia (AMM) Reagent Product Usage: AMM reagent, when used in conjunction with SYNCHRON LX System(s), UniCel DxC 600/800 System(s) and SYNCHRON Systems Ammonia Calibrators, is intended for the quantitative determination of Ammonia concentration in human plasma.
FDA Recall
Terminated
·Beckman Coulter Inc.·Product code JIF·March 26, 2009
ADVIA Ammonia (AMM) chemistry assay, an in vitro diagnostic device intended to quantitatively measure Ammonia levels in human plasma (heparin or EDTA). Product Number: 10286035 (Mfr: Randox Laboratories)
FDA Recall
Terminated
·Siemens Healthcare Diagnostics, Inc.·Product code JIF·June 29, 2017
Sentinel MULTIGENT Ammonia Ultra Reagent, In-Vitro Diagnostic for ammonia measurement; List Number: LN 6K89-30. Intended for the in vitro quantitative determination of Ammonia (NH3) in human plasma.
FDA Recall
Terminated
·Sentinel CH SpA Via Robert Koch 2 Milano Italy·Product code JIF·September 22, 2015
Ammonia Liquid Stable Reagent, Enzymatic Method. Catalog number TR60101. in vitro diagnostic.
FDA Recall
Terminated
·Thermo Fisher Scientific·Product code JIF·July 24, 2007
AM1015 Randox Ammonia (NH3), Enzymatic UV Method For the quantitative in vitro determination of Ammonia in plasma
FDA Recall
Terminated
·RANDOX LABORATORIES, LTD. 34 Diamond Rd Crumlin Colorado Antrim United Kingdom·Product code JIF·July 30, 2020
Dimension Vista Ammonia Flex reagent cartridge / AMM Dimension: The AMM method is an in vitro diagnostic test for the quantitative measurement of ammonia in human plasma on the Dimension clinical chemistry system. Ammonia measurements are used in the diagnosis and treatment of severe liver disorders such as cirrhosis, hepatitis and Reye s syndrome
FDA Recall
Terminated
·Siemens Healthcare Diagnostics, Inc.·Product code JIF·December 16, 2016
Philips Respironics V60 Ventilator Part Number R1053618 - Product Usage: intended to be used only with various combinations of Respironics-recommended patient circuits, interfaces (masks), humidifiers, and other accessories.
FDA Enforcement
Class II
·Terminated·Respironics California, LLC·February 3, 2021
Philips Respironics V60 Ventilator Part Number 1076717 - Product Usage: intended to be used only with various combinations of Respironics-recommended patient circuits, interfaces (masks), humidifiers, and other accessories.
FDA Enforcement
Class II
·Terminated·Respironics California, LLC·February 3, 2021
Philips Respironics V60 Ventilator Part Number U1053617 - Product Usage: intended to be used only with various combinations of Respironics-recommended patient circuits, interfaces (masks), humidifiers, and other accessories.
FDA Enforcement
Class II
·Terminated·Respironics California, LLC·February 3, 2021
Philips Respironics V60 Ventilator Part Number 1053616 - Product Usage: intended to be used only with various combinations of Respironics-recommended patient circuits, interfaces (masks), humidifiers, and other accessories.
FDA Enforcement
Class II
·Terminated·Respironics California, LLC·February 3, 2021
Endurant II/IIs Stent Graft System: STENT GRAFT ETBF3216C145E ENDUR II BIF. For treatment of vascular aneurysms.
FDA Recall
Terminated
·Medtronic Vascular, Inc.·Product code MIH·April 28, 2021
Philips Respironics V60 Ventilator Part Number DU1053617 - Product Usage: intended to be used only with various combinations of Respironics-recommended patient circuits, interfaces (masks), humidifiers, and other accessories.
FDA Enforcement
Class II
·Terminated·Respironics California, LLC·February 3, 2021
Endurant II/IIs Stent Graft System: STENT GRAFT ETBF3216C145E ENDUR II BIF. For treatment of vascular aneurysms.
FDA Enforcement
Class II
·Terminated·Medtronic Vascular, Inc.·July 7, 2021
Philips Respironics V60 Ventilator Part Number 1053618 - Product Usage: intended to be used only with various combinations of Respironics-recommended patient circuits, interfaces (masks), humidifiers, and other accessories.
FDA Enforcement
Class II
·Terminated·Respironics California, LLC·February 3, 2021
Philips Respironics V60 Ventilator Part Number 1137292 - Product Usage: intended to be used only with various combinations of Respironics-recommended patient circuits, interfaces (masks), humidifiers, and other accessories.
FDA Enforcement
Class II
·Terminated·Respironics California, LLC·February 3, 2021