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

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    Cocoon Convective Warming System, Product Code: CWS5000 (110V).

    FDA Enforcement
    Class II ·Terminated·Care Essentials Pty., Ltd.·February 12, 2020

    Logical cup liner - Product Usage: intended to replace a hip joint where bone stock is sufficient to support the implant.

    FDA Enforcement
    Class II ·Terminated·Signature Orthopedics Pty Limited·June 9, 2021

    Bio-CORE Cannula (Needle) Set

    FDA Recall
    Terminated ·Biologic Therapies, Inc·Product code FGY·January 23, 2015

    BECKMAN COULTER ACCESS Immunoassay Systems - Access Unconjugated Estriol, REF 33570.

    FDA Recall
    Terminated ·Beckman Coulter Inc.·Product code CGI·August 26, 2020

    BD Interlink threaded lock cannula This is a locking blunt plastic cannula specifically designed for IV connection to an Interlink injection site. It is screwed down over the Interlink injection site and a blunt plastic cannula inside the housing enters the Interlink injection site to provide a pathway for IV fluid administration.

    FDA Recall
    Terminated ·Becton Dickinson & Company·Product code FGY·November 26, 2013

    Bio-MAC Cannula (Needle) Set

    FDA Recall
    Terminated ·Biologic Therapies, Inc·Product code FGY·January 23, 2015

    Fusion OMNI- GT * DOME TIP: ERCP Catheter: 6.0 FR./200 CM. 8 Minimum Accessory Channel: 4.2 MM * Disposable Single Use Only * Compatible Wire Guide: .035'' * Rx Only * Wilson-Cook Medical * GI Endoscope * 4900 Betharine Station * Winston-Salem, NC 27105

    FDA Recall
    Terminated ·Wilson-Cook Medical Inc·Product code FGY·October 31, 2005

    Bio-PLASTY Cannula (Needle)

    FDA Recall
    Terminated ·Biologic Therapies, Inc·Product code FGY·January 23, 2015

    Access Immunoassay Systems UNCONJUGATED ESTRIOL Part # 33570 The Access Unconjugated Estriol assay is a paramagnetic particle, chemiluminescent immunoassay for the quantitative determination of unconjugated estriol levels in human serum using the Access Immunoassay Systems.

    FDA Recall
    Terminated ·Beckman Coulter Inc.·Product code CGI·December 8, 2009

    MAQUET GETINGE GROUP Arterial Cannula OD Used to introduce blood and sterile solutions into the systemic circulation during pediatric extracorporeal circulation procedures.

    FDA Recall
    Terminated ·Maquet Cardiovascular Us Sales, Llc·Product code FGY·May 14, 2013

    Psi Bands acupressure/acustimulation wrist bands in the following colors: Racer Black (UPC 859570001036), Daisy Chain (UPC 859570001029), Color Play (UPC 859570001043) and Cherry Blossom (UPC 859570001012).

    FDA Recall
    Terminated ·Psi Health Solutions·Product code MVV·April 26, 2007

    Signature Ceramic Femoral Head. Model Number: 111-152-621. The Signature ceramic femoral heads are manufactured by Ceramtec from 72-75% Al2O3+24-26% Z3O3 (Biolox Delta). The heads connect via a 12/14 taper to the stem trunnion, and articulates against the crosslinked UHMWPE liner within the Logical Acetabular Cups. Product Usage: Components of the Signature Orthopaedics hip replacement range are intended to replace a hip joint where bone stock is sufficient to support the implant. When a surgeon has selected prosthetic replacement as the preferred treatment, the devices are indicated for: Non-inflammatory degenerative joint disease including osteoarthritis or avascular necrosis Inflammatory joint disease including rheumatoid arthritis Correction of functional deformity including congenital hip dysplasia Traumatic injury involving the hip joint including traumatic arthritis or femoral head or neck fracture Failed previous hip surgery including internal fixation or joint fusion, reconstruction, hemiarthroplasty, surface replacement, or total replacement

    FDA Recall
    Terminated ·Signature Orthopedics Pty Limited·Product code MEH·February 2, 2018

    Ellex Solo LT5106-S ophthalmic laser (not sold in USA)

    FDA Recall
    Terminated ·Ellex Medical Pty Ltd·Product code HQF·February 15, 2011

    Ellex Motorised Safety Filter, Zeiss; Model number 6339585. Intended for photocoagulation.

    FDA Recall
    Terminated ·Ellex Medical Pty Ltd·Product code HQF·February 11, 2009

    Motorised Safety Filter, Wild; Model number 6339590. Intended for photocoagulation.

    FDA Recall
    Terminated ·Ellex Medical Pty Ltd·Product code HQF·February 11, 2009

    Ellex Super Q LQP3106 ophthalmic laser

    FDA Recall
    Terminated ·Ellex Medical Pty Ltd·Product code HQF·February 15, 2011

    Cocoon Convective Warming System, Product Code: CWS5000 (110V).

    FDA Recall
    Terminated ·Care Essentials Pty., Ltd.·Product code DWJ·January 7, 2020

    Alcon 3000LE ophthalmic laser

    FDA Recall
    Terminated ·Ellex Medical Pty Ltd·Product code HQF·February 15, 2011

    Cocoon Convective Warming System, Product Code: CWS4000 (110V).

    FDA Recall
    Terminated ·Care Essentials Pty., Ltd.·Product code DWJ·January 7, 2020

    Ellex Tango LT5106-T ophthalmic laser (not sold in USA)

    FDA Recall
    Terminated ·Ellex Medical Pty Ltd·Product code HQF·February 15, 2011