BEUDAMED
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    ABLE INNOVATIONS INC.

    FDA registration
    ABLE INNOVATIONS INC.·1 product·🇨🇦 Canada

    Delfi Medical Innovations, VariFit Contour Cuffs, single use adult thigh cuff, single port, single bladder, REF 9-9300-003. Rx Only, Sterile

    FDA Enforcement
    Class II ·Terminated·Delfi Medical Innovations, Inc.·May 13, 2020

    DELFI SINGLE USE VARIFIT TOURNIQUET CUFF SINGLE PORT SINGLE BLADDER CONTOUR THIGH CUFF WITH MATHCING LIMP PROTECTION SLEEVE Rx Only, Sterile

    FDA Enforcement
    Class II ·Terminated·Delfi Medical Innovations, Inc.·May 13, 2020

    INSTRUMENT MANAGER SOFTWARE

    FDA Adverse Event
    Malfunction ·DATA INNOVATIONS LLC·Product code JQP·July 8, 2019

    WILLOW 3.0 BREAST PUMP

    FDA Adverse Event
    Malfunction ·WILLOW INNOVATIONS, INC.·Product code HGX·November 1, 2023

    WILLOW WEARABLE BREAST PUMP

    FDA Adverse Event
    Injury ·WILLOW INNOVATIONS, INC.·Product code HGX·March 20, 2022

    INNOVANCE D-DIMER

    FDA Adverse Event
    Malfunction ·SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS GMBH·Product code DAP·August 28, 2017

    GORE® VIABAHN® VBX BALLOON EXPANDABLE ENDOPROSTHESIS

    FDA Adverse Event
    Injury ·W. L. GORE & ASSOCIATES, INC.·Product code PRL·March 25, 2024

    Delfi Medical Innovations, VariFit Contour Cuffs, single use adult thigh cuff, single port, single bladder, REF 9-9300-003. Rx Only, Sterile

    FDA Recall
    Terminated ·Delfi Medical Innovations, Inc.·Product code KCY·April 3, 2019

    TACTICATH¿ CONTACT FORCE ABLATION CATHETER, SENSOR ENABLED¿

    FDA Adverse Event
    Injury ·ST. JUDE MEDICAL·Product code OAE·March 6, 2025

    DELFI SINGLE USE VARIFIT TOURNIQUET CUFF SINGLE PORT SINGLE BLADDER CONTOUR THIGH CUFF WITH MATHCING LIMP PROTECTION SLEEVE Rx Only, Sterile

    FDA Recall
    Terminated ·Delfi Medical Innovations, Inc.·Product code KCY·April 3, 2019

    UNKNOWN TALAR COMPONENT

    FDA Adverse Event
    Injury ·STRYKER GMBH·Product code NTG·April 1, 2020

    UNKNOWN TIBIAL COMPONENT

    FDA Adverse Event
    Injury ·STRYKER GMBH·Product code HSN·April 1, 2020

    UNKNOWN POLYETHYLENE COMPONENT

    FDA Adverse Event
    Injury ·STRYKER GMBH·Product code HSN·April 1, 2020

    GORE® EXCLUDER® AAA ENDOPROSTHESIS

    FDA Adverse Event
    Injury ·W. L. GORE & ASSOCIATES, INC.·Product code MIH·December 21, 2023

    GORE® VIABAHN® VBX BALLOON EXPANDABLE ENDOPROSTHESIS

    FDA Adverse Event
    Injury ·W. L. GORE & ASSOCIATES, INC.·Product code PRL·March 25, 2024

    UNKNOWN TALAR COMPONENT

    FDA Adverse Event
    Injury ·STRYKER GMBH·Product code NTG·March 31, 2020

    UNKNOWN TALAR COMPONENT

    FDA Adverse Event
    Injury ·STRYKER GMBH·Product code HSN·March 31, 2020

    UNKNOWN TALAR COMPONENT

    FDA Adverse Event
    Injury ·STRYKER GMBH·Product code NTG·March 31, 2020

    UNKNOWN POLYETHYLENE INSERT 6MM

    FDA Adverse Event
    Injury ·STRYKER GMBH·Product code HSB·March 31, 2020