BEUDAMED
    49 results · 21ms · Sources: EU EUDAMED, US FDA

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    iba COMPASS SW Version 3.0, Catalog Number CS10-100 (medical linear accelerator) radiological

    FDA Enforcement
    Class II ·Terminated·Iba Dosimetry Gmbh·December 18, 2013

    Maquet Getinge- BEQ-TOP 54500 BSW-McLANE 3/8 Quadrox iD Material:709000496R01

    FDA Recall
    Terminated ·Maquet Cardiovascular, LLC·Product code DWF·April 18, 2019

    Maquet Getinge- BEQ-TOP 54500 BSW-McLANE 3/8 Quadrox iD Material:709000496R01

    FDA Enforcement
    Class II ·Terminated·Maquet Cardiovascular, LLC·June 5, 2019

    Flexichamber Anti-Static Valved Collapsible Holding Chamber, used by patients to administer aerosolized medication from most pressurized Metered Dose Inhalers(pMDIs).

    FDA Recall
    Terminated ·FSC Laboratories, Inc·Product code NVP·May 16, 2016

    Flexichamber Anti-Static Valved Collapsible Holding Chamber, used by patients to administer aerosolized medication from most pressurized Metered Dose Inhalers(pMDIs).

    FDA Enforcement
    Class II ·Terminated·FSC Laboratories, Inc·June 22, 2016

    Carestream DRX Evolution System, X-Ray System --- The DRX-Evolution system is a permanently installed diagnostic x-ray system for generation of x-rays for examination of various anatomical regions.

    FDA Recall
    Terminated ·Carestream Health Inc.·Product code KPR·June 3, 2013

    Integra Surgical Luxtec MLX Light Source Catalog Numbers: 00MLX Product Usage: The Integra Luxtec MLX Light Source is designed to supply high intensity white light through a fiber optic cable for illumination of a surgical field during a surgical and or medical procedure.

    FDA Recall
    Terminated ·Integra LifeSciences Corp.·Product code FCW·October 14, 2011

    Polyflex Esophageal Stent 20/16mm x 90mm

    FDA Recall
    Terminated ·Boston Scientific Corporation·Product code ESW·April 16, 2003

    Polyflex Esophageal Stent 20/16mm x 120mm

    FDA Recall
    Terminated ·Boston Scientific Corporation·Product code ESW·April 16, 2003

    Boston Scientific Ultraflex Covered large Esophageal Stent System - Distal Release (23/28/10/7) Material/UPN/Catalog Number: M00514200

    FDA Recall
    Terminated ·Boston Scientific Corporation·Product code ESW·July 15, 2010

    Ultraflex Esophageal Stent System. Uncovered - Distal Release - 18/23/15. Catalog Number M00513720. Single Use, Rx only. Boston Scientific, Natick, MA 01760. Intended for maintaining esophageal luminal patency in esophageal structures caused by intrinsic and/or extrinsic malignant tumors only and occlusion of concurrent esophageal fistulas.

    FDA Recall
    Terminated ·Boston Scientific Corporation·Product code ESW·May 17, 2010

    Titan Pump - Product Usage: indicated for male patients suffering from erectile dysfunction (impotence) who are considered to be candidates for implantation of a penile prosthesis.

    FDA Recall
    Terminated ·Coloplast Manufacturing US, LLC·Product code FHW·October 23, 2020

    Ultraflex Esophageal Stent System. Uncovered - Proximal Release - 18/23/10. Catalog Number M00513810. Single Use, Rx only. Boston Scientific, Natick, MA 01760. Intended for maintaining esophageal luminal patency in esophageal structures caused by intrinsic and/or extrinsic malignant tumors only and occlusion of concurrent esophageal fistulas.

    FDA Recall
    Terminated ·Boston Scientific Corporation·Product code ESW·May 17, 2010

    Coloplast Titan OTR Inflatable Penile Prosthesis,18cm scrotal Bioflex cylinder set w/OTR Pump, P/N QSR9181400. Sterile EO. Manufacturer: Coloplast A/S, 3050 Denmark. Distributed by: Coloplast Corp., Minneapolis, MN 55411 USA. Indicated for male patients suffering from erectile dysfunction who are considered to be candidates for implantation of a penile prosthesis.

    FDA Recall
    Terminated ·Coloplast Manufacturing US, LLC·Product code FHW·October 6, 2009

    Polyflex Esophageal Stent 25/21mm x 150mm

    FDA Recall
    Terminated ·Boston Scientific Corporation·Product code ESW·April 16, 2003

    Integra Surgical Luxtec MLX Light Source Catalog Numbers: 00MLXAU Product Usage: The Integra Luxtec MLX Light Source is designed to supply high intensity white light through a fiber optic cable for illumination of a surgical field during a surgical and or medical procedure.

    FDA Recall
    Terminated ·Integra LifeSciences Corp.·Product code FCW·October 14, 2011

    Luxtec MLX 300 Watt Xenon Light Source, Model OOMLX; Surgical/Medical Light Source This light source is designed to supply high-intensity light to a fiber optic cable for illumination of a surgical field during a surgical and/or medical procedure.

    FDA Recall
    Terminated ·Integra LifeSciences Corp.·Product code FCW·March 7, 2011

    Polyflex Esophageal Stent 25/21mm x 90mm

    FDA Recall
    Terminated ·Boston Scientific Corporation·Product code ESW·April 16, 2003

    Polyflex Esophageal Stent 23/18mm x 90mm

    FDA Recall
    Terminated ·Boston Scientific Corporation·Product code ESW·April 16, 2003

    Ultraflex Esophageal Stent System. Uncovered - Proximal Release - 18/23/15. Catalog Number M00513830. Single Use, Rx only. Boston Scientific, Natick, MA 01760. Intended for maintaining esophageal luminal patency in esophageal structures caused by intrinsic and/or extrinsic malignant tumors only and occlusion of concurrent esophageal fistulas.

    FDA Recall
    Terminated ·Boston Scientific Corporation·Product code ESW·May 17, 2010