BEUDAMED
    1,167 results · 23ms · Sources: EU EUDAMED, US FDA

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    Natus Neurology ErgoJust Carts labeled as the following: ICU Cart Export For PTZ Video Ext, IP PTZ HD ErgoJust Video Extension, EuroJust ICU Cart Export For PTZ Video Ext. Video cart used for mobile medical record documentation.

    FDA Recall
    Terminated ·Natus Neurology DBA Excel Tech., Ltd. (XLTEK)·Product code ODI·May 18, 2018

    Capnostream20 M ADULT ICU (CPM), CS08654RA

    FDA Recall
    Terminated ·Oridion Medical 1987 Ltd. Har Hotzvim Industrial·Product code DQA·July 31, 2018

    Natus Neurology ErgoJust Carts labeled as the following: ICU Cart Export For PTZ Video Ext, IP PTZ HD ErgoJust Video Extension, EuroJust ICU Cart Export For PTZ Video Ext. Video cart used for mobile medical record documentation.

    FDA Enforcement
    Class II ·Terminated·Natus Neurology DBA Excel Tech., Ltd. (XLTEK)·August 15, 2018

    DeRoyal Sterile Custom Kits containing ICU Medical MicroClave Clear Connectors

    FDA Recall
    Terminated ·DeRoyal Industries Inc·Product code LRO·August 12, 2022

    Capnostream20 M ADULT ICU (CPM), CS08654RA

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

    NIC02 Model 7600 Refurbished, Respironics/Philips product. Intended use is cardiac output monitoring via the method of partial rebreathing in adult patients receiving mechanical ventilation during general anesthesia and in the ICU ; spirometric and carbon dioxide monitoring in neonatal, pediatric and adult patients during general anesthesia and in the ICU and emergency department.

    FDA Recall
    Terminated ·Philips Healthcare Inc.·Product code CCK·November 19, 2009

    French 100-120V NICO 7300, Respironics/Philips product. Intended use is: cardiac output monitoring via the method of partial rebreathing in adult patients receiving mechanical ventilation during general anesthesia and in the ICU ; spirometric and carbon dioxide monitoring in neonatal, pediatric and adult patients during general anesthesia and in the ICU and emergency department.

    FDA Recall
    Terminated ·Philips Healthcare Inc.·Product code CCK·November 19, 2009

    NIC02 Model 7600 Demo Unit, Respironics/Philips product. Intended use is cardiac output monitoring via the method of partial rebreathing in adult patients receiving mechanical ventilation during general anesthesia and in the ICU ; spirometric and carbon dioxide monitoring in neonatal, pediatric and adult patients during general anesthesia and in the ICU and emergency department.

    FDA Recall
    Terminated ·Philips Healthcare Inc.·Product code CCK·November 19, 2009

    Spanish 100-120V NICO 7300, Respironics/Philips product. Intended use is cardiac output monitoring via the method of partial rebreathing in adult patients receiving mechanical ventilation during general anesthesia and in the ICU ; spirometric and carbon dioxide monitoring in neonatal, pediatric and adult patients during general anesthesia and in the ICU and emergency department.

    FDA Recall
    Terminated ·Philips Healthcare Inc.·Product code CCK·November 19, 2009

    ICU Medical Cogent Hemodynamic Monitoring System, Cogent Item Number 58400-000, UDI: (01)00840619079499

    FDA Recall
    Terminated ·ICU Medical, Inc.·Product code DXQ·July 12, 2019

    Diana Automated Compounding System, Diana Onco Plus 1.2, Item No. ASN222, ASN222-GST, ASN222-R The Diana is an automated compounding device for the accurate, safe and efficient preparation of solutions by a pharmacist prior to delivery for infusion into patient.

    FDA Recall
    Terminated ·ICU Medical, Inc.·Product code NEP·March 8, 2016

    Diana Automated Compounding System, Diana V1.3, Item No. CH5300, CH5300R The Diana is an automated compounding device for the accurate, safe and efficient preparation of solutions by a pharmacist prior to delivery for infusion into patient.

    FDA Recall
    Terminated ·ICU Medical, Inc.·Product code NEP·March 8, 2016

    Diana Automated Compounding System, Final Assembly, Diana Onco Plus, Item No. CH5000, CH5000R The Diana is an automated compounding device for the accurate, safe and efficient preparation of solutions by a pharmacist prior to delivery for infusion into patient.

    FDA Recall
    Terminated ·ICU Medical, Inc.·Product code NEP·March 8, 2016

    Diana Automated Compounding System, Diana Onco Plus 1.3, Item No. ASN223 The Diana is an automated compounding device for the accurate, safe and efficient preparation of solutions by a pharmacist prior to delivery for infusion into patient.

    FDA Recall
    Terminated ·ICU Medical, Inc.·Product code NEP·March 8, 2016

    Diana Automated Compounding System, Diana Onco Plus, Item No. ASN220 The Diana is an automated compounding device for the accurate, safe and efficient preparation of solutions by a pharmacist prior to delivery for infusion into patient.

    FDA Recall
    Terminated ·ICU Medical, Inc.·Product code NEP·March 8, 2016

    Diana Automated Compounding System, Diana Onco 3xx, Item No. ASN303 The Diana is an automated compounding device for the accurate, safe and efficient preparation of solutions by a pharmacist prior to delivery for infusion into patient.

    FDA Recall
    Terminated ·ICU Medical, Inc.·Product code NEP·March 8, 2016

    100-200V NICO, 7300 Cardio Mgt System, Refurbished, Respironics/Philips product. The intended use is cardiac output monitoring via the method of partial rebreathing in adult patients receiving mechanical ventilation during general anesthesia and in the ICU ; spirometric and carbon dioxide monitoring in neonatal, pediatric and adult patients during general anesthesia and in the ICU and emergency department.

    FDA Recall
    Terminated ·Philips Healthcare Inc.·Product code CCK·November 19, 2009

    100-120V NICO, 7300 Cardio Mgt system, Respironics/Philips product. Intended use is cardiac output monitoring via the method of partial rebreathing in adult patients receiving mechanical ventilation during general anesthesia and in the ICU ; spirometric and carbon dioxide monitoring in neonatal, pediatric and adult patients during general anesthesia and in the ICU and emergency department.

    FDA Recall
    Terminated ·Philips Healthcare Inc.·Product code CCK·November 19, 2009

    DeRoyal Sterile Custom Kits containing ICU Medical MicroClave Clear Connectors

    FDA Enforcement
    Class II ·Terminated·DeRoyal Industries Inc·September 7, 2022

    83" (211 cm) Appx 10.3 mL, 60 Drop Primary Set w/BCV-Clave, Stat 2 Flow Controller, Clave, Rotating Luer, Item No. B9897. Product Usage: IV Administration sets are intended for the infusion and withdrawal of fluids. The devices are provided sterile.

    FDA Recall
    Terminated ·ICU Medical, Inc.·Product code FMG·August 19, 2014