BEUDAMED
    41 results · 11ms · Sources: EU EUDAMED, US FDA

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    Newton IQ 4 Lead Cycler Set with stay-safe patient connectors, used for acute and chronic peritoneal dialysis. Catalog Number: 050-87028

    FDA Recall
    Terminated ·Fresenius Medical Care North America·Product code FKX·March 22, 2006

    IM Abbott Alinity ci-series (abdicqii) accessory driver v8.00.0001 software product that can receive information from a hospital computer system (also called a Laboratory Information System [LIS]).

    FDA Enforcement
    Class II ·Terminated·Data Innovations, LLC·October 31, 2018

    IM Abbott Alinity ci-series (abdicqii) accessory driver v8.00.0001 software product that can receive information from a hospital computer system (also called a Laboratory Information System [LIS]).

    FDA Recall
    Terminated ·Data Innovations, LLC·Product code JQP·August 29, 2018

    SpermMar Test 0.7ml Beads Particles Label on bottle: SpermMar Test IgA 0.7ml Beads/Particles-50 Tests IND REF SPMA_S LOT Expiration DO NOT FREEZE/NE PAS CONGELER FertiPro N.V. Label on box: SpermMar Test IGA 50 Determination Test Kit CONTENTS 1 vial SpermMar Latex Particles 0.7 ml REF SPMA_S FertiPro FertiPro N.V. Label on box: SpermMar Test IgA 50 Determination Test Kit Contents: 1 vial SpermMar latex particles, 0.7ml FertiPro N.V. For In Vitro Diagnostic Use SpermMar IqA Test Manufacturer's Product Number/Catalog Number: SPMA_S Lot/Serial Number Expiration Date FP14A09 02/29/2016 FP14A10 04/30/2016 FP14A11 04/30/2016 Product is a solution in filled into clear plastic bottles that is placed into a cardboard box. Both packages contain labeling information.

    FDA Enforcement
    Class II ·Terminated·Vitrolife Inc·April 22, 2015

    BariAir AC-Powered Adjustable Hospital Beds

    FDA Recall
    Terminated ·Kinetic Concepts, Inc·Product code IOQ·April 11, 2000

    Flexicair MC3 (model M4000) Low Airloss Therapy Units, for the prevention of pressure sores.

    FDA Recall
    Terminated ·Hill-Rom Manufacturing, Inc.·Product code IOQ·May 12, 2009

    IsoFlex LAL Support Surface, Model Number 2860 Product Usage: : The IsoFlex LAL support surface assists in the prevention and treatment of all pressure injuries (including stages 1,2,3,4, unstageable injury, and deep tissue injury) and is recommended to be implemented in combination with clinical evaluation of risk factors and skin assessments made by a health care professional. This support surface is for use with human patients with existing or at risk of incurring pressure injuries. The patient must not exceed the safe working load as specified by the support surface. A healthcare professional should determine the use of this support surface by patients outside of the therapeutic weight range. The minimum patient age requirement for this support surface is two years. IsoFlex LAL shall be used with a support surface cover at all times. The support surface cover can interact with all external skin. This support surface is for use by patients in an acute care setting. This may include critical care, step down, progressive care, med/surg, subacute care, and post anesthesia care unit (PACU), or other locations as prescribed by a physician. Operators of this support surface include healthcare professionals (such as nurses, nurse aids, or doctors). IsoFlex LAL support surface is not intended to: be used in a home health environment setting be used as a sterile product include a measuring function be used with a patient less than two years of age Stryker promotes the clinical assessment of each patient and appropriate usage by the operator.

    FDA Recall
    Terminated ·Stryker Medical Division of Stryker Corporation·Product code IOQ·August 13, 2018

    HomeSafe AutoAlert Pendant works in conjunction with a compatible Lifeline communicator.

    FDA Recall
    Terminated ·Lifeline Systems Company·Product code ILQ·November 13, 2017

    MedMinder Medication Dispenser- Intended to serve as a medication reminder to promote medication adherence with additional feature to communicate with emergency call center.

    FDA Recall
    Terminated ·Medminder Systems, Inc.·Product code ILQ·March 28, 2022

    PediDyne AC-Powered Adjustable Hospital Beds

    FDA Recall
    Terminated ·Kinetic Concepts, Inc·Product code IOQ·April 11, 2000

    KCI Underbed Inverter, Accessory to Powered Flotation Therapy Bed, manufactured by Kinetic Concepts, Inc., San Antonio, TX. Model number 201189

    FDA Recall
    Terminated ·Kinetic Concepts, Inc·Product code IOQ·March 22, 2004

    Arial Wireless Water-Resistant Call Pendant The Arial Pendant tag is part of the Arial wireless emergency call management system. It enables residents in assisted living, skilled nursing or independent living to call staff with the press of a button.

    FDA Recall
    Terminated ·Stanley Security Solutions Inc·Product code ILQ·June 22, 2016

    Philips Lifeline Personal Help Button Pendant Classic and Slimline Style.

    FDA Recall
    Terminated ·Philips Lifeline Inc·Product code ILQ·September 11, 2009

    FLEXICAIR II, Low Airloss Therapy unit.This unit is similar to MC3 but does not have the utility shelf above the foodboard, patient scale or alternate CPR function actuators.

    FDA Recall
    Terminated ·Hill-Rom Manufacturing, Inc.·Product code IOQ·August 27, 2003

    Envision E700 Low Airloss Therapy Surface, Made By Hill-Rom Manufacturing, Inc., Charleston, SC. The Envision E700 Low Airloss Therapy Surface helps prevent and treat stage III and stage IV pressure ulcers in patients who weigh between 70 lb and 400 lb and are between 4'11" and 6' 4" in height.

    FDA Recall
    Terminated ·Hill-Rom Manufacturing, Inc.·Product code IOQ·June 19, 2008

    AC Power Cords, 110V Manufactured by Electri-Cord Manufacturing Company in Westfield, PA. Power Cord #4102204 used with Tricell 60601 Model 212857, First Step Select Model 215200 , and Plexipulse Model 205835.

    FDA Recall
    Terminated ·KCI USA, Inc.·Product code IOQ·November 4, 2009

    P10 Tobii battery box (product number 510410) Product Usage - Battery pack for MyTobii P10 Device. MyTobii P10 is a portable eye-controlled communication device featuring the Tobii Eye Control system.

    FDA Recall
    Terminated ·Tobii Assistive Technology, Inc.·Product code ILQ·January 14, 2013

    IsoGel AIR 84, Support Surface. Intended to assist in improving human patient outcomes.

    FDA Recall
    Terminated ·Stryker Medical Division of Stryker Corporation·Product code IOQ·July 12, 2013

    Responder 5 is a nurse call communication system that connects patients with staff in a hospital. The nurse call system also connects team members and departments from radiology, physical therapy, transport, environmental services and more. Responder 5 is used in hospitals and long term patient care facilities to allow for remote communications between patients and patient monitoring devices and healthcare providers

    FDA Recall
    Terminated ·Rauland-Borg Corp·Product code ILQ·May 10, 2013

    Voalte Nurse Call System provides a comprehensive communication and information system that places patient calls, staff calls, and emergency calls.

    FDA Recall
    Terminated ·Baxter Healthcare Corporation·Product code ILQ·April 13, 2022