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

    Get notified when this changes

    We'll email you when new records match this search — new devices, new clearances, certificate changes, or withdrawals.
    Filters Status: Completed ×

    POWERPORT ClearVUE Slim with Smooth Septum, 8F ChronoFlex, Polyurethane Catheter with open suture holes, REF 5678300

    FDA Recall
    Completed ·Bard Peripheral Vascular Inc·Product code LJT·February 8, 2018

    POWERPORT(R) ClearVUE(R) isp with Smooth Septum, 6F ChronoFlex(TM), Polyurethane Catheter, REF 1666362

    FDA Recall
    Completed ·Bard Peripheral Vascular Inc·Product code LJT·February 8, 2018

    POWERPORT ClearVUE Slim with Smooth Septum, 8F ChronoFlex, Polyurethane Catheter with Open Suture Holes, REF 1678301

    FDA Recall
    Completed ·Bard Peripheral Vascular Inc·Product code LJT·February 8, 2018

    POWERPORT ClearVUE Slim with Smooth Septum, 6F ChronoFlex Silk, Polyurethane Catheter, REF 5676300

    FDA Recall
    Completed ·Bard Peripheral Vascular Inc·Product code LJT·February 8, 2018

    POWERPORT ClearVUE Slim with Smooth Septum, 8F ChronoFlex, Polyurethane Catheter, REF 1678300

    FDA Recall
    Completed ·Bard Peripheral Vascular Inc·Product code LJT·February 8, 2018

    POWERPORT ClearVUE isp with Smooth Septum, 8F ChronoFlex, Polyurethane Catheter, REF 5668362

    FDA Recall
    Completed ·Bard Peripheral Vascular Inc·Product code LJT·February 8, 2018

    POWERPORT ClearVUE Slim with Smooth Septum, 8F ChronoFlex, Polyurethane Catheter with open suture holes, REF 5678301

    FDA Recall
    Completed ·Bard Peripheral Vascular Inc·Product code LJT·February 8, 2018

    POWERPORT ClearVUE Slim with Smooth Septum, 6F ChronoFlex, Polyurethane Catheter with Open Suture Holes, REF 1676301

    FDA Recall
    Completed ·Bard Peripheral Vascular Inc·Product code LJT·February 8, 2018

    POWERPORT ClearVUE Slim with Smooth Septum, 6F ChronoFlex Silk, Polyurethane Catheter with Open Suture Holes, REF 5676301

    FDA Recall
    Completed ·Bard Peripheral Vascular Inc·Product code LJT·February 8, 2018

    POWERPORT ClearVUE Slim Implantable Port with Smooth Septum and Attachable 8F Polyurethane Open-Ended Single-Lumen Venous Catheter Custom Kit, REF CP00005

    FDA Recall
    Completed ·Bard Peripheral Vascular Inc·Product code LJT·February 8, 2018

    POWERPORT ClearVUE isp with Smooth Septum, 8F ChronoFlex, Polyurethane Catheter, REF 1668362

    FDA Recall
    Completed ·Bard Peripheral Vascular Inc·Product code LJT·February 8, 2018

    POWERPORT ClearVUE isp with Smooth Septum, 6F ChronoFlex, Polyurethane Catheter, REF 5666362

    FDA Recall
    Completed ·Bard Peripheral Vascular Inc·Product code LJT·February 8, 2018

    POWERPORT CLEARVUE isp, 6F CHRONOFLEX Catheter, Intermediate NAUTILUS DELTA Kit; POWERPORT CLEARVUE isp, 8F CHRONOFLEX Catheter, Intermediate NAUTILUS DELTA Kit; POWERPORT CLEARVUE Slim, 6F CHRONOFLEX Catheter and Suture Plugs, Intermediate NAUTILUS DELTA Kit; POWERPORT CLEARVUE Slim, 8F CHRONOFLEX Catheter and Suture Plugs, Intermediate NAUTILUS DELTA Kit; NAUTILUS DELTA Tip Confirmation System (Includes: Netbook with Pre-loaded Software, Patient Module, and ECG Cable) Product Usage: Is an implantable access device designed to provide repeated access to the vascular system.

    FDA Recall
    Completed ·Bard Peripheral Vascular Inc·Product code LJT·June 25, 2018

    POWERPORT ClearVUE isp Implantable Port With Smooth Septum and Attachable 8F Polyurethane Open-Ended Single-Lumen Venous Catheter Custom Kit, REF CP00004

    FDA Recall
    Completed ·Bard Peripheral Vascular Inc·Product code LJT·February 8, 2018

    POWERPORT ClearVUE Slim with Smooth Septum, 6F ChronoFlex Silk, Polyurethane Catheter, REF 1676300

    FDA Recall
    Completed ·Bard Peripheral Vascular Inc·Product code LJT·February 8, 2018

    Humeral Augmented Tray (HAT) trials that are components of KIT-321HAT. Each tray contains 1 of each of the following catalog numbers for a total of 6 trials/tray: (1) HAT STD Left Tray Trial, Cat. #321-00-01; (2) HAT STD Right Tray Trial, Cat. #321-00-02; (3) HAT LAT Left Tray Trial, Cat. #321-00-11; (4) HAT LAT Right Tray Trial, Cat. #321-00-12; (5) HAT EXT LAT Left Trial, Cat. #321-00-21; and (6) HAT EXT LAT Right Trial, Cat. #321-00-22. The Humeral Augmented Tray is designed to function with the Equinoxe Reverse Shoulder System orthopedic implant components.

    FDA Enforcement
    Class II ·Completed·Exactech, Inc.·July 7, 2021

    Humeral Augmented Tray (HAT) trials that are components of KIT-321HAT. Each tray contains 1 of each of the following catalog numbers for a total of 6 trials/tray: (1) HAT STD Left Tray Trial, Cat. #321-00-01; (2) HAT STD Right Tray Trial, Cat. #321-00-02; (3) HAT LAT Left Tray Trial, Cat. #321-00-11; (4) HAT LAT Right Tray Trial, Cat. #321-00-12; (5) HAT EXT LAT Left Trial, Cat. #321-00-21; and (6) HAT EXT LAT Right Trial, Cat. #321-00-22. The Humeral Augmented Tray is designed to function with the Equinoxe Reverse Shoulder System orthopedic implant components.

    FDA Recall
    Completed ·Exactech, Inc.·Product code PHX·May 11, 2021

    LEGION(TM) HEMI STEP TIBIAL WEDGE RK/HK, 5 MM, SIZE 3-4 LT.MDL/RT-LAT, REF 71423432 Product Usage: The constrained knee systems are designed for use in patients in primary and revision surgery, where the posterior cruciate ligament and one or both of the collateral ligaments (i.e., medial collateral and/or lateral collateral ligament) are absent or incompetent.

    FDA Enforcement
    Class II ·Completed·Smith & Nephew, Inc.·September 18, 2019

    LEGION(TM) HEMI STEP TIBIAL WEDGE RK/HK, 5 MM, SIZE 3-4 LT.MDL/RT-LAT, REF 71423432 Product Usage: The constrained knee systems are designed for use in patients in primary and revision surgery, where the posterior cruciate ligament and one or both of the collateral ligaments (i.e., medial collateral and/or lateral collateral ligament) are absent or incompetent.

    FDA Recall
    Completed ·Smith & Nephew, Inc.·Product code JWH·January 15, 2018