BEUDAMED
    86 results · 14ms · Sources: EU EUDAMED, US FDA

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    QUADROX iD HMOD 2030 Diffusion Membrane Oxygenator; QUADROX-i ADULT HMO 70000 / HMO 71000; QUADROX-iD Pediatric HMOD 30000. The QUADROX oxygenators are intended for use in extracorporeal circulation during cardiopulmonary bypass in cardiac surgery.

    FDA Recall
    Terminated ·Maquet Cardiovascular Us Sales, Llc·Product code DTZ·August 15, 2013

    Babi.Plus 12.5 cm H2O Pressure Relief Manifold, REF 1030, RX Only, UDI: 04710810093562

    FDA Enforcement
    Class I ·Terminated·Galemed Corporation·January 1, 2020

    Babi.Plus 12.5 cm H2O Pressure Relief Manifold Catalog # 2691 for use with ventilators.

    FDA Enforcement
    Class I ·Terminated·TELEFLEX-MORRISVILLE·November 13, 2019

    Babi.Plus Bubble PAP Valve with 12.5 cm H2O Pressure Relief Manifold, REF 1002, Rx Only, UDI: 24710810093559

    FDA Enforcement
    Class I ·Terminated·Galemed Corporation·January 1, 2020

    Babi.Plus 12.5 cm H2O Pressure Relief Manifold with Gas Supply Tube and Oxygen Sensor Port, REF 2691, Rx Only, UDI: 04710810100802

    FDA Enforcement
    Class I ·Terminated·Galemed Corporation·January 1, 2020

    Hospitak Pediatric Manual Pulmonary Resuscitator with reservoir bag, face mask and Pop-Off 40 cm H2O Elbow. Product ID # 730-E; Hospitak Infant Manual Pulmonary Resuscitator with reservoir bag, face mask and Pop-Off 40 cm H2O Elbow, Product ID # 730MM.

    FDA Recall
    Terminated ·Unomedical·Product code BTM·October 6, 2009

    QUADROX iD HMOD 2030 Diffusion Membrane Oxygenator; QUADROX-i ADULT HMO 70000 / HMO 71000; QUADROX-iD Pediatric HMOD 30000. The QUADROX oxygenators are intended for use in extracorporeal circulation during cardiopulmonary bypass in cardiac surgery.

    FDA Enforcement
    Class II ·Terminated·Maquet Cardiovascular Us Sales, Llc·October 2, 2013

    EXTREME H2O 59% (hioxifilcon A) spherical soft contact lens for daily wear - Product Usage: indicated for the correction of visual acuity in aphakic or not-aphakic persons with non-diseased eyes that are myopic or hyperopic. The lens may be worn by persons who exhibit astigmatism of 0.75 Diopters or less that does not interfere with visual acuity.

    FDA Enforcement
    Class II ·Terminated·Clerio Vision·April 14, 2021

    MVP-10 Pediatric/ Neonatal Volume Ventilator

    FDA Recall
    Terminated ·Bio-Med Devices, Inc.·Product code MNT·November 7, 2003

    Maquet Getinge-BO-TOP 15200 OR PACK HMO & RF Material:701050647R01

    FDA Recall
    Terminated ·Maquet Cardiovascular, LLC·Product code DWF·April 18, 2019

    Babi.Plus 12.5 cm H2O Pressure Relief Manifold Catalog # 2691 for use with ventilators.

    FDA Recall
    Terminated ·TELEFLEX-MORRISVILLE·Product code BZD·June 14, 2019

    SS-H2O Aerospray Deionized Water, 500 mL, IVD, Wescor, Inc, Logan, Utah 84321.

    FDA Recall
    Terminated ·Wescor, Inc·Product code HYB·January 6, 2010

    Babi.Plus 12.5 cm H2O Pressure Relief Manifold, REF 1030, RX Only, UDI: 04710810093562

    FDA Recall
    Terminated ·Galemed Corporation 87 Wu-Jia Li-Gong 2nd Road I-Lan Taiwan·Product code BZD·May 30, 2019

    Multiva systems; 1) Magnets Multiva 16 Model 781487, 2) Magnets 8 Model 781488, 3) Magnet Achieva 1.5T, Model 781492, 4) Magnet HFO, Model 781495, 5) Magnet Multiva 16, Model 781496, 6) Magnet Multiva 8, Model 781497 & 7) Magnets Ingenia 1.5T CX, Model 781498 Product Usage: Indicated for use as a diagnostic device. It can produce cross-sectional images, spectroscopic images and/or spectra in any orientation of the internal structure of the head, body,or extremities.

    FDA Enforcement
    Class II ·Terminated·Philips Electronics North America Corporation·April 25, 2018

    Clerio Vision, extreme H2O monthly, MED, DIA 14.0 PWR -2.25, UPC 675506803334 (6 count) and UPC 675506804478 (12 count) - Product Usage: for daily wear is indicated for the correction of visual acuity in aphakic or not-aphakic persons with non-diseased eyes that are myopic or hyperopic. The lens may be worn by persons who exhibit astigmatism of 0.75 Diopters or less that does not interfere with visual acuity.

    FDA Enforcement
    Class II ·Terminated·Clerio Vision·January 20, 2021

    Babi.Plus Bubble PAP Valve with 12.5 cm H2O Pressure Relief Manifold, REF 1002, Rx Only, UDI: 24710810093559

    FDA Recall
    Terminated ·Galemed Corporation 87 Wu-Jia Li-Gong 2nd Road I-Lan Taiwan·Product code BZD·May 30, 2019

    Maquet Servo Ventilator 300/300A (SV300) Siemens - Elema AB,

    FDA Recall
    Terminated ·MAQUET Inc.·Product code CBK·November 17, 2009

    Maquet Servo Ventilator SV900C/D/E (SV900) Siemens-Elema AB, Solna, Sweden

    FDA Recall
    Terminated ·MAQUET Inc.·Product code CBK·November 17, 2009

    QUADROX iD HMOD 2030 Diffusion Membrane Oxygenator; QUADROX-i ADULT HMO 70000 / HMO 71000; QUADROX-iD Pediatric HMOD 30000 Product Usage: The QUADROX oxygenators are intended for the use in extracorporeal circulation during cardiopulmonary bypass in cardiac surgery. Within the specified flow rate range, the device oxygenates the blood, eliminates carbon dioxide and regulates blood temperature. The devices utilization period is limited to six hours.

    FDA Recall
    Terminated ·Maquet Cardiovascular Us Sales, Llc·Product code DTZ·June 12, 2012

    Maquet Getinge-BO-TOP 15200 OR PACK HMO & RF Material:701050647R01

    FDA Enforcement
    Class II ·Terminated·Maquet Cardiovascular, LLC·June 5, 2019