BEUDAMED
    22 results · 36ms · Sources: EU EUDAMED, US FDA

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    ClearCell® FX1 Unit

    FDA UDI
    BIOLIDICS LIMITED·08885016030003·

    Toptolife

    FDA UDI
    BIOLIFE DIGNITY HEALTH INTERNATIONAL LIMITED·14897115200103·S1 Nitrile Exam Gloves, Size M

    Toptolife

    FDA UDI
    BIOLIFE DIGNITY HEALTH INTERNATIONAL LIMITED·14897115200110·S1 Nitrile Exam Gloves, Size L

    Toptolife

    FDA UDI
    BIOLIFE DIGNITY HEALTH INTERNATIONAL LIMITED·14897115200097·S1 Nitrile Exam Gloves, Size S

    Toptolife

    FDA UDI
    BIOLIFE DIGNITY HEALTH INTERNATIONAL LIMITED·14897115200127·S1 Nitrile Exam Gloves, Size XL

    RENU SENS. MULTI-PURPOSE SOL.(MILAN)

    FDA Adverse Event
    Injury ·BAUSCH & LOMB INCORPORATED·Product code LPN·October 12, 2021

    Small Patient ECC Pack, REF BEQ-TOP 24100, Product Usage: The HLM Tubing Sets with Bioline Coating are for single use only. They may be sold sterile, non-sterile and bulk packed. Custom tubing sets that are sold sterile are not to be re-sterilized by the user. In open heart surgery the HLM Tubing Sets with Bioline Coating are used in combination with the heart-lung machine for the oxygenation of blood and removal of carbon dioxide. The main purpose of the HLM Tubing Sets with Bioline Coating is to connect the patient to the hear-lung machine and its components. The HLM Tubing Sets with Bioline Coating are therefore a component in the extracorporeal perfusion circulation system. The utilization period of the use of the tubing sets is restricted to six hours

    FDA Enforcement
    Class II ·Terminated·Datascope Corporation·June 22, 2016

    Small Patient ECC Pack, REF BEQ-TOP 24100, Product Usage: The HLM Tubing Sets with Bioline Coating are for single use only. They may be sold sterile, non-sterile and bulk packed. Custom tubing sets that are sold sterile are not to be re-sterilized by the user. In open heart surgery the HLM Tubing Sets with Bioline Coating are used in combination with the heart-lung machine for the oxygenation of blood and removal of carbon dioxide. The main purpose of the HLM Tubing Sets with Bioline Coating is to connect the patient to the hear-lung machine and its components. The HLM Tubing Sets with Bioline Coating are therefore a component in the extracorporeal perfusion circulation system. The utilization period of the use of the tubing sets is restricted to six hours

    FDA Recall
    Terminated ·Datascope Corporation·Product code DWE·May 9, 2016

    RENU (UNKNOWN TYPE)

    FDA Adverse Event
    Injury ·BAUSCH & LOMB, INC.·Product code LPN·November 3, 2006

    RENU (UNK TYPE)

    FDA Adverse Event
    Injury ·BAUSCH & LOMB, INC.·Product code LPN·December 1, 2006

    RENU (UNKNOWN TYPE)

    FDA Adverse Event
    Injury ·BAUSCH & LOMB, INC.·Product code LPN·November 3, 2006

    RENU (UNKNOWN TYPE)

    FDA Adverse Event
    Injury ·BAUSCH & LOMB, INC.·Product code LPN·November 13, 2006

    RENU MULTI-PURPOSE SOLUTION

    FDA Adverse Event
    Injury ·BAUSCH & LOMB, INC.·Product code LPN·January 18, 2007

    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 Enforcement
    Class II ·Terminated·Maquet Cardiovascular Us Sales, Llc·November 7, 2012

    RENU WITH MOISTURELOC MULTI-PURPOSE SOLUTION

    FDA Adverse Event
    Injury ·BAUSCH & LOMB, INC.·Product code LPN·August 24, 2006

    RENU WITH MOISTURELOC MULTI-PURPOSE SOLUTION

    FDA Adverse Event
    Injury ·BAUSCH & LOMB, INC.·Product code LPN·August 24, 2006

    RENU MULTIPLUS MULTI-PURPOSE SOLUTION

    FDA Adverse Event
    Injury ·BAUSCH & LOMB, INC.·Product code LPN·September 28, 2006

    RENU WITH MOISTURELOC MULTI-PURPOSE SOLUTION

    FDA Adverse Event
    Injury ·BAUSCH & LOMB, INC.·Product code LPN·August 25, 2006

    RENU WITH MOISTURELOC MULTI-PURPOSE SOLUTION

    FDA Adverse Event
    Injury ·BAUSCH & LOMB, INC.·Product code LPN·October 30, 2006

    CIDEX OPA SOLUTION

    FDA Adverse Event
    Injury ·ADVANCED STERILIZATION PRODUCTS·Product code MED·July 19, 2016