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

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    Invacare Pronto Air Personal Transporter (power wheelchair), Invacare Corporation, One Invacare Way, Elyria, Ohio, 44035-4190, (800) 333 -6900.

    FDA Recall
    Terminated ·Invacare Corporation·Product code ITI·February 2, 2015

    Invacare¿ Pronto¿ Air Personal Transporter (power wheelchair), Invacare Corporation, One Invacare Way, Elyria, Ohio, 44035-4190, (800) 333 -6900.

    FDA Enforcement
    Class II ·Terminated·Invacare Corporation·August 19, 2015

    Amicus Exchange Kit - Product Usage: intended for use in the collection of blood components and mononuclear cells.

    FDA Recall
    Terminated ·Fenwal Inc·Product code LKN·February 25, 2021

    Amicus MNC Apheresis Kit - Double Needle - Product Usage: intended for use in the collection of blood components and mononuclear cells.

    FDA Recall
    Terminated ·Fenwal Inc·Product code GKT·February 25, 2021

    Amicus Exchange Kit Therapeutics - Product Usage: intended for use in the collection of blood components and mononuclear cells.

    FDA Recall
    Terminated ·Fenwal Inc·Product code LKN·February 25, 2021

    Kuschall K Junior Manual wheelchair

    FDA Recall
    Terminated ·Invacare Corporation·Product code IOR·June 15, 2009

    DeVilbiss iFill Personal Oxygen Station model number 535D.

    FDA Recall
    Terminated ·Sunrise Medical·Product code CAW·August 24, 2006

    AMSCO Evolution steam sterilizer Transfer Carriage. Product Usage: Mobile, wheeled transportation unit utilized to carry, load, & unload the Loading Car into and out of steam sterilizer units.

    FDA Recall
    Terminated ·Steris Corporation·Product code FLE·October 18, 2013

    Cmax Surgical Tables, Model #'s: Cmax110, Cmax 220 manufactured by Steris Corporation in Montgomery, AL

    FDA Recall
    Terminated ·Steris Corporation·Product code FQO·August 12, 2010

    The STERIS 4085 General Surgical Table Product Usage: is an electro-hydraulically operated surgical table designed to support all general surgical procedures.

    FDA Recall
    Terminated ·Steris Corporation·Product code FQO·June 27, 2014

    SYSTEM 1E Liquid Chemical Sterilant Processing System, Model # P6500, S/N: 400001 through 405005; Mfr. By: STERIS Corporation, Mentor, OH 44060. Product Usage: The SYSTEM 1E Liquid Chemical Sterilant Processing System is intended for the liquid chemical sterilization of manually cleaned immersible and reusable critical and semi-critical heat sensitive medical devices, including endoscopes and their accessories.

    FDA Recall
    Terminated ·Steris Corporation·Product code MLR·August 11, 2011

    Evolution Loading Car and Transfer Carriage- Accessory to the Sterilizer, Steam

    FDA Recall
    Terminated ·Steris Corporation·Product code FLE·October 22, 2019

    AMICUS Exchange Kit; Product Usage: This kit is designed for use with the AMICUS separator for the Therapeutic Plasma Exchange (TPE) procedure. Sterilized by irradiation. Sterile fluid path. Non-pyrogenic fluid path.

    FDA Recall
    Terminated ·Fenwal Inc·Product code LKN·May 24, 2013

    Leo 3-Wheel Scooter and Leo Scooter, Distributed By: Invacare Corporation, 1200 Taylor Street, Elyria, OH 44035 Intended to provide transportation for a disabled or elderly person.

    FDA Recall
    Terminated ·Invacare Corporation·Product code INI·December 7, 2011

    The Reliance 130 and 130L Cart Washer/Disinfector is a high capacity mechanical washer intended for use in the washing, low-level disinfecting, and drying of carts, utensils, beds and other miscellaneous reusable items used in the care of patients at healthcare facilities / Crated for shipping.

    FDA Recall
    Terminated ·Steris Corporation·Product code MEC·July 14, 2012

    The SYSTEM 1E Liquid Sterilant Processing System. The SYSTEM 1E Liquid Sterilant Processing System is intended for the liquid chemical sterilization of manually cleaned immersible and reusable critical and semi-critical heat sensitive medical devices, including endoscopes and their accessories.

    FDA Recall
    Terminated ·Steris Corporation·Product code MED·August 1, 2012

    Invacare AC-Powered Adjustable Hospital Bed. Model 5890 IVC and 5490 IVC. Manufactured by: Invacare Corp. 2101 East Lake Mary Blvd., Sanford, FL 32773.

    FDA Recall
    Terminated ·Invacare Corporation·Product code FNL·October 16, 2006

    SYSTEM 1E Liquid Chemical Sterilant Processing System, Distributed by STERIS Corporation, Mentor, OH The SYSTEM 1E Liquid Chemical Sterilant Processing System is intended for the liquid chemical sterilization of manually cleaned immersible and reusable critical and semi-critical heat sensitive medical devices, including endoscopes and their accessories.

    FDA Recall
    Terminated ·Steris Corporation·Product code MLR·November 21, 2013

    TDX SP Power Wheelchair, Model #'s: TDXSP-CG, TDXSP-CG-GT, TDXSP-MCG, TDXSP-MCG-GT, Distributed By: Invacare Corporation, Elyria, OH 44035 The Invacare TDX power wheelchair is a battery powered, motor driven device with the intended function and use of providing mobility to those persons limited to a sitting position that have the capability of operating a power wheelchair. It is a rigid or non-folding type power wheelchair, with mid wheel drive capability.

    FDA Recall
    Terminated ·Invacare Corporation·Product code ITI·February 10, 2012

    Angiotech Drainage Cather. SKATER Centesis Cather XFr. STERILE. Product Number: 700304007, 700304010, 700304015, 700305007, 700305010, 7003015. 510k Exempt. Qty Dist. - 4,250. MEDICAL DEVICE TECHNOLOGIES, INC. 3600 Southwest 74th Avenue, Gainesville, Florida 32608 U.S.A. Intended Use: Drainage Cather

    FDA Recall
    Terminated ·Medical Device Technologies, Inc.·Product code JCY·September 1, 2009