47 results · 16ms · Sources: EU EUDAMED, US FDA

Get notified when this changes

We'll email you when new records match this search — new devices, new clearances, certificate changes, or withdrawals.

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: 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

CAPNOSTREAM 20P (INTL) N W/PRINTER - ROHS, CS08658-03

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 (US) N - ROHS, Part Number CS08651-03

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 M ADULT ICU (CPM), CS08654RA

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 REFURBISHED, CS78654

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

CAPNOSTREAM 20P (US) N W/PRINTER - ROHS, Part Number CS08657-03

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 M W/PRINTER CYVITAL, CS08796

FDA Enforcement
Class II ·Terminated·Oridion Medical 1987 Ltd.·October 10, 2018

CAPNOSTREAM 20P (US) N W/PRINTER, Part Number CS08657-01

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

CAPNOSTREAM 20P (US) N, Part Number CS08651-01

FDA Enforcement
Class II ·Terminated·Oridion Medical 1987 Ltd.·October 10, 2018

CAPNOSTREAM 20P (INTL) N - ROHS, Part Number CS08652-02

FDA Enforcement
Class II ·Terminated·Oridion Medical 1987 Ltd.·October 10, 2018

CAPNOSTREAM 20 (INTL) N W/PRINTER, Part Number CS08658

FDA Enforcement
Class II ·Terminated·Oridion Medical 1987 Ltd.·October 10, 2018

CAPNOSTREAM 20P (INTL) N, Part Number CS08652-01

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