BEUDAMED
    103 results · 57ms · Sources: EU EUDAMED, US FDA

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    Brand Name: Quantum Perfusion Centrifugal Blood Pump CP22 with Integrated Sensors Product Name: Pump, Blood, Cardiopulmonary Bypass, Non-Roller Type Model/Catalog Number: CP22V-VT Software Version: N/A

    FDA Recall
    Open, Classified ·Spectrum Medical Inc·Product code KFM·January 16, 2025

    Brand Name: Quantum Informatics - VIPER Product Name: Monitor, Physiological, Patient (Without Arrhythmia Detection or Alarms) Product Description: VIPER is a software-only device (SaMD) that is intended to provide near real-time patient safety and clinical best practice solutions for the high-risk patient population in the operating room (OR). VIPER integrates multiple information feeds that supports the real-time distribution of critical patient information and the deployment of advanced active Patient Safety Systems and clinical Best Practice. By integrating compliance, complication, and sophisticated alerting systems, VIPER offers improved support for the avoidance of adverse events.

    FDA Recall
    Open, Classified ·Spectrum Medical Ltd. Harrier 4, Meteor Business Park Cheltenham Road East Gloucester United Kingdom·Product code MWI·March 19, 2025

    Brand Name: Quantum Informatics - VISION / LIVE VUE Product Name: Monitor, Physiological, Patient (Without Arrhythmia Detection or Alarms) Product Description: VISION / LIVE VUE is a software-only device (SaMD) that is intended to provide near real-time patient safety and clinical best practice solutions for the high-risk patient population in the operating room (OR). VISION / LIVE VUE integrates multiple information feeds that supports remote monitoring of near real-time critical patient information and the deployment of advanced active Patient Safety Systems and clinical Best Practice. By integrating compliance, critical care scoring systems, and sophisticated alerting systems, VISION / LIVE VUE offers improved support for ensuring compliance to hospital-specific protocols. The software solution also allows for big data queries, routine reporting, and review of quality performance metrics.

    FDA Recall
    Open, Classified ·Spectrum Medical Ltd. Harrier 4, Meteor Business Park Cheltenham Road East Gloucester United Kingdom·Product code MWI·March 19, 2025

    Fabius Tiro Anesthesia Machine, OR/Anesthesia, Draeger Medical, Inc., 3135 Quarry Road, Telford, PA 18969 Compact anesthesia system that offers the full spectrum of anesthesia ventilation to military anesthesiologists/ CRNAs in the field of operations. Can be used in a variety of mobile and stationary military applications where general anesthesia is required.

    FDA Recall
    Terminated ·Draeger Medical Systems, Inc.·Product code BSZ·August 26, 2010

    Spectrum Central Venous Catheter Tray, Minocydine/Rifampin Antibiotic Impregnated, Double Lumen, 7.5Fr/20cm, CUDLMY751JRSCABRMFST, G13482, Sterile, Cook Medical, Cook Incorporated, Bloomington, IN.

    FDA Recall
    Terminated ·Cook, Inc.·Product code FOZ·October 4, 2010

    Spectrum Central Venous Catheter Tray, Minocydine/Rifampin Antibiotic Impregnated, Double Lumen, 9.5Fr/15cm, CUDLMY953JABRMFST, G13481, Sterile, Cook Medical, Cook Incorporated, Bloomington, IN.

    FDA Recall
    Terminated ·Cook, Inc.·Product code FOZ·October 4, 2010

    Spectrum Central Venous Catheter Tray, Minocycline/Rifampin Antibiotic Impregnated, 5 Lumen Polyurethane, 10 Fr/ 15 cm, C-UQLMY-1001J-ABRM-HC-FST-RD, G51540, Sterile, Cook, Inc., Bloomington, IN.

    FDA Recall
    Terminated ·Cook, Inc.·Product code FOZ·October 4, 2010

    Spectrum Central Venous Tray, Minocycline/Rifampin Impregnated Double Lumen Polyurethane, 4.0 Fr/ 8cm, C-SDLMY-401J-ABRM-IHI-FST, G48047, Sterile, Cook Medical, Cook Incorporated, Bloomington, IN.

    FDA Recall
    Terminated ·Cook, Inc.·Product code FOZ·October 4, 2010

    Spectrum Central Venous Tray Minocycline/Rifampin Impregnated Double Lumen Polyurethane Catheter, 7.0 Fr/ 25 cm, C-UDLMY-801J-ABRM-HC-FST-A, G50819, Sterile, Cook Medical, Cook Incorporated, Bloomington, IN.

    FDA Recall
    Terminated ·Cook, Inc.·Product code FOZ·October 4, 2010

    Spectrum Central Venous Tray, Minocycline/Rifampin Impregnated Double Lumen Polyurethane, 4.0 Fr/ 5cm, C-UDLMY-401J-PED-ABRM-HC-IHI-FST, G48059, Sterile, Cook Medical, Cook Incorporated, Bloomington, IN.

    FDA Recall
    Terminated ·Cook, Inc.·Product code FOZ·October 4, 2010

    Spectrum Central Venous Tray, Minocycline/Rifampin Impregnated Triple Lumen Polyurethane Catheter, 7.0 Fr/ 25cm, C-UTLMY-701J-LSC-ABRM-HC-FST-RD, G47832, Sterile, Cook Medical, Cook Incorporated, Bloomington, IN.

    FDA Recall
    Terminated ·Cook, Inc.·Product code FOZ·October 4, 2010

    Spectrum Central Venous Catheter Tray, Minocycline/Rifampin Antibiotic Impregnated, Double Lumen Polyurethane, 5.0 Fr/5 cm, CUDLMY501JPED- ABRM-HC-FST, G43982, Sterile, Cook Medical, Cook Incorporated, Bloomington, IN.

    FDA Recall
    Terminated ·Cook, Inc.·Product code FOZ·October 4, 2010

    Spectrum Central Venous Tray, Minocycline/Rifampin Impregnated Triple Lumen Polyurethane, 5.0 Fr/ 5cm, C-UTLMY-501J-RSC-ABRM-HC-IHI-FST, G48124, Sterile, Cook Medical, Cook Incorporated, Bloomington, IN.

    FDA Recall
    Terminated ·Cook, Inc.·Product code FOZ·October 4, 2010

    Spectrum Central Venous Catheter Tray Minocycline/Rifampin Antibiotic Impregnated, Double lumen Polyurethane, 7.5Fr/20cm, CUDLMY751JRSCABRMFSTA, G29518, Sterile, Cook Medical, Cook Incorporated, Bloomington, IN.

    FDA Recall
    Terminated ·Cook, Inc.·Product code FOZ·October 4, 2010

    Spectrum Central Venous Catheter Tray, Minocycline/Rifampin Antibiotic Impregnated, 5 Lumen Polyurethane, 10.0Fr/25cm, CUQLMY1001JLSCABRMFSTA, G43135, Sterile, Cook Medical, Cook Incorporated, Bloomington, IN.

    FDA Recall
    Terminated ·Cook, Inc.·Product code FOZ·October 4, 2010

    Spectrum Central Venous Tray, Minocycline/Rifampin Impregnated 5 Lumen Polyurethane, 10.0 Fr/ 15cm, C-UQLMY-1001J-ABRM-IHI-FST-A, G448109, Sterile, Cook Medical, Cook Incorporated, Bloomington, IN.

    FDA Recall
    Terminated ·Cook, Inc.·Product code FOZ·October 4, 2010

    Spectrum Central Venous Tray, Minocycline/Rifampin Impregnated Triple Lumen Polyurethane, 5.0 Fr/ 15cm, C-UTLMY-501J-LSC-ABRM-HC-IHI-FST, G48117, Sterile, Cook Medical, Cook Incorporated, Bloomington, IN.

    FDA Recall
    Terminated ·Cook, Inc.·Product code FOZ·October 4, 2010

    Spectrum Central Venous Tray, Minocycline/Rifampin Impregnated Triple Lumen Polyurethane Catheter 7.0 Fr/ 15cm, C-UTLMY-701J-ABRM-HC-FST-A-RD, G44126, Sterile, Cook Medical, Cook Incorporated, Bloomington, IN.

    FDA Recall
    Terminated ·Cook, Inc.·Product code FOZ·October 4, 2010

    Spectrum Central Venous Catheter Tray Minocycline/Rifampin Antibiotic Impregnated, Double lumen Polyurethane, 7.5Fr/15cm, C-UDLMY-751J-190-PIG-ABRM-FST-A, G30102, Sterile, Cook Medical, Cook Incorporated, Bloomington, IN.

    FDA Recall
    Terminated ·Cook, Inc.·Product code FOZ·October 4, 2010

    Spectrum Central Venous Tray, Minocycline/Rifampin Impregnated Double Lumen Polyurethane, 5.0 Fr/ 12cm, C-UDLMY-501J-RSC-ABRM-HC-IHI-FST, G48076, Sterile, Cook Medical, Cook Incorporated, Bloomington, IN.

    FDA Recall
    Terminated ·Cook, Inc.·Product code FOZ·October 4, 2010