45 results
·
10ms
·
Sources: EU EUDAMED, US FDA
Microstream Instructions for Use and Part Number used with - Product Description, REF: FilterLine Sets & VitaLine Sets Adult/Pediatric, MQ04616 - MICROSTREAM FilterLine H Set Long Adult-Pediatric CO2 Sampling Line and Airway Adapter for Humid Environments, 007737; MICROSTREAM FilterLine Set Long Adult-Pediatric CO2 Sampling Line and Airway Adapter, 007768; MICROSTREAM FilterLine Set Adult-Pediatric CO2 Sampling Line and Airway Adapter, 010579; MICROSTREAM FilterLine H Set Adult-Pediatric CO2 Sampling Line and Airway Adapter for Humid Environments, 010580; MICROSTREAM VitaLine H Set Adult-Pediatric CO2 Sampling Line and Airway Adapter for High Ambient Humidity X25, 010787; MICROSTREAM FilterLine Set Adult-Pediatric CO2 Sampling Line and Airway Adapter for Humid Environments, 015016; MICROSTREAM FilterLine Set Adult-Pediatric CO2 Sampling Line and Airway Adapter, 015021; MICROSTREAM FilterLine Set Adult-Pediatric CO2 Sampling Line and Airway Adapter, XS04620; MICROSTREAM FilterLine H Set Adult-Pediatric CO2 Sampling Line and Airway Adapter for Humid Environments, XS04624.
FDA Enforcement
Class II
·Ongoing·Oridion Medical 1987 Ltd.·March 26, 2025
Microstream Instructions for Use and Part Number used with - Product Description, REF: FilterLine H Set & VitaLine H Set Infant/Neonatal, 006147 - MICROSTREAM FilterLine H Set Infant/Neonatal CO2 Sampling Line and Airway Adapter for Humid Environments, 006324; MICROSTREAM FilterLine H Set Long Infant/Neonatal CO2 Sampling Line and Airway Adapter for Humid Environments, 007738; MICROSTREAM VitaLine H Set Infant/Neonatal CO2 Sampling Line and Airway Adapter for Humid Environments, 010807.
FDA Enforcement
Class II
·Ongoing·Oridion Medical 1987 Ltd.·March 26, 2025
Microstream Instructions for Use and Part Number used with - Product Description, REF: OmniVentLine Set, 012808 - OmniVentLine Set Adult-Pediatric CO2 Sampling Line and Airway Adapter, 012495;
FDA Enforcement
Class II
·Ongoing·Oridion Medical 1987 Ltd.·March 26, 2025
Capnostream20 M W/PRINTER CYVITAL, CS08796
FDA Enforcement
Class II
·Terminated·Oridion Medical 1987 Ltd.·October 10, 2018
Capnostream20 (US) M TO MASIMO, Part Number CS08750
FDA Enforcement
Class II
·Terminated·Oridion Medical 1987 Ltd.·October 10, 2018
Capnostream20 (INTL) N REFURBISHED, CS78652
FDA Enforcement
Class II
·Terminated·Oridion Medical 1987 Ltd.·October 10, 2018
Capnostream20 M ADULT ICU (CPM), CS08654RA
FDA Enforcement
Class II
·Terminated·Oridion Medical 1987 Ltd.·October 10, 2018
Capnostream20 N W/PRINTER CYVITAL, CS08798
FDA Enforcement
Class II
·Terminated·Oridion Medical 1987 Ltd.·October 10, 2018
Capnostream20 (INTL) N W/PRINTER REFURBISHED, CS78658
FDA Enforcement
Class II
·Terminated·Oridion Medical 1987 Ltd.·October 10, 2018
Capnostream20 (INTL) M W/PRINTER REFURBISHED, CS78660
FDA Enforcement
Class II
·Terminated·Oridion Medical 1987 Ltd.·October 10, 2018
Capnostream20 (INTL) M REFURBISHED, CS78654
FDA Enforcement
Class II
·Terminated·Oridion Medical 1987 Ltd.·October 10, 2018
CAPNOSTREAM 20P (COV-INTL) N W/PRINTER ROHS, CS051COV
FDA Enforcement
Class II
·Terminated·Oridion Medical 1987 Ltd.·October 10, 2018
Capnostream20 N CYVITAL, CS08799
FDA Enforcement
Class II
·Terminated·Oridion Medical 1987 Ltd.·October 10, 2018
Capnostream20 (INTL) M W/PRINTER, CS08660
FDA Enforcement
Class II
·Terminated·Oridion Medical 1987 Ltd.·October 10, 2018
Capnostream20 (US) M W/PRINTER REFURBISHED, Part Number CS78659
FDA Enforcement
Class II
·Terminated·Oridion Medical 1987 Ltd.·October 10, 2018
Capnostream20 (US) N REFURBISHED, Part Number CS78651
FDA Enforcement
Class II
·Terminated·Oridion Medical 1987 Ltd.·October 10, 2018
Capnostream20 (US)M REFURBISHED, Part Number CS78653
FDA Enforcement
Class II
·Terminated·Oridion Medical 1987 Ltd.·October 10, 2018
Capnostream20 (US) N W/PRINTER REFURBISHED, Part Number CS78657
FDA Enforcement
Class II
·Terminated·Oridion Medical 1987 Ltd.·October 10, 2018
Capnostream20 (INTL) M, CS08654
FDA Enforcement
Class II
·Terminated·Oridion Medical 1987 Ltd.·October 10, 2018
CAPNOSTREAM 20P (INTL) N W/PRINTER - ROHS, CS051COV-03
FDA Enforcement
Class II
·Terminated·Oridion Medical 1987 Ltd.·October 10, 2018