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

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    Filters Classification: Class Ii ×

    Invacare¿ I-Fit" Shower Chair (Models 9780, 9781, 9781-1), Invacare Corporation, Elyria, OH 44035. These shower chairs are designed for individuals who require seating support when bathing or showering and provide comfort and safety in the bathtub.

    FDA Enforcement
    Class II ·Terminated·Invacare Corporation·October 3, 2012

    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

    TDX SP Power Wheelchair, TDX SR Power Wheelchair, TDX SI Power Wheelchair. Model Number(s): TDXSI, TDXSI-2, TDXSI-2-S, TDXSI-CG, TDXSI-HD, TDXSI-HD-S, TDXSIV, TDXSIV-2, TDXSIV-2-S, TDXSIV-HD, TDXSIV-HD-S, TDXSP, TDXSPBASE, TDXSP-CG, TDXSPEURO, TDXSP-MCG, TDXSP-MCG-GT, TDXSR, TDXSR-CG, TDXSR-CG-HD, TDXSR-MCG, FDX, FDX-CG, FDXEURO-14, FDX-MCG. Mrf. By: Invacare Corporation, 1200 Taylor Street, Elyria, OH 44035. Intended to provide mobility to a person restricted to a sitting position.

    FDA Enforcement
    Class II ·Terminated·Invacare Corporation·July 11, 2012

    Invacare Homecare Series Bed and Invacare G-Series Beds Containing Component Model Numbers: (1) G50 (2) G53 (3) G54 (4) BAR5490IVC (5) BAR5000IVC (6) 5000IVC (7) 5490IVC (8) 5490LOW

    FDA Enforcement
    Class II ·Ongoing·Invacare Corporation·March 13, 2024

    Invacare TDX SP2, Model Nos. TDXSP2 TDXSP2-MCG TDXSP2V

    FDA Enforcement
    Class II ·Ongoing·Invacare Corporation·June 1, 2022

    Invacare¿ Foot Section for Semi & Full Electric Beds, Junction Boxes, Product Usage: The Invacare Bariatric home care bed is intended to provide a rest surface with adjustable height from floor and adjustable surface contours.

    FDA Enforcement
    Class II ·Terminated·Invacare Corporation·August 17, 2016

    Invacare Height Adjustable (walking) Canes, Model Numbers: 8916, 8917, and 40918-6. The device is packaged six (6) canes per shipping carton. The cane is used as an aid in walking or ambulation.

    FDA Enforcement
    Class II ·Terminated·Invacare Corporation·December 26, 2012

    Invacare¿ Bariatric Bed w/o mattress & rails, Junction Boxes, Product Usage: The Invacare Bariatric home care bed is intended to provide a rest surface with adjustable height from floor and adjustable surface contours.

    FDA Enforcement
    Class II ·Terminated·Invacare Corporation·August 17, 2016

    Assist Bed Rail - 6632

    FDA Enforcement
    Class II ·Terminated·Invacare Corporation·June 7, 2017

    Component- Dianz Capacitor used in PerfectO2 Oxygen Concentrator, packaged one unit per box.

    FDA Enforcement
    Class II ·Terminated·Invacare Corporation·December 31, 2014

    Junction Boxes, Product Usage: The Invacare Bariatric home care bed is intended to provide a rest surface with adjustable height from floor and adjustable surface contours.

    FDA Enforcement
    Class II ·Terminated·Invacare Corporation·August 17, 2016

    Invacare Precise Rx Pediatric Flowmeter Model Number: IRCPF16 AW. Packed one per carton. The lnvacare Precise Rx" Pediatric Flowmeter adapts to lnvacare Concentrators for low-flow usage.The gauge has a scale printed on the front side and the back side. The front scale is the primary source for monitoring oxygen flow. The rear scale is an aide for monitoring oxygen flow.

    FDA Enforcement
    Class II ·Terminated·Invacare Corporation·August 17, 2016

    Tracer IV wheelchairs, Heavy duty manual wheel chair, 24" seat width, 450 lbs. weight capacity. Distributed by Invacare, Elyria, OH 44035 For transportation to accomplish necessary tasks of daily living in a home or community environment for the user.

    FDA Enforcement
    Class II ·Terminated·Invacare Corporation·January 15, 2014

    Invacare¿ Bariatric Bed with mattress and rails , Junction Boxes, Product Usage: The Invacare Bariatric home care bed is intended to provide a rest surface with adjustable height from floor and adjustable surface contours.

    FDA Enforcement
    Class II ·Terminated·Invacare Corporation·August 17, 2016

    lnvacare Precise Rx Pediatric Flowmeter Model Number: IRCPF16. Packed one per carton. The lnvacare Precise Rx Pediatric Flowmeter adapts to lnvacare Concentrators for low-flow usage.The gauge has a scale printed on the front side and the back side. The front scale is the primary source for monitoring oxygen flow. The rear scale is an aide for monitoring oxygen flow.

    FDA Enforcement
    Class II ·Terminated·Invacare Corporation·August 17, 2016

    MK5 NX Controller--Wheelchair controller

    FDA Enforcement
    Class II ·Terminated·Invacare Corporation·July 30, 2014

    Aquatec Fixed Backrest - accessory for Mobile Shower and Toilet commode Aquatec Ocean, Ocean VIP and Ocean E-VIP family.

    FDA Enforcement
    Class II ·Terminated·Invacare Corporation·July 16, 2014

    Solara 3G Custom Manual Wheelchair Product Usage: To provide mobility to a person restricted to a sitting position.

    FDA Enforcement
    Class II ·Terminated·Invacare Corporation·February 13, 2013

    CHAMPION Medical Recliner, AC Powered with heat and massage, one chair per carton, or one chair wrapped in a blanket if delivered in person. Recliner provides heat and massage after surgery.

    FDA Enforcement
    Class II ·Terminated·Invacare Corporation·August 28, 2013

    Aquatec Ocean VIP, Aquatec Ocean Dual-VIP, Aquatec Ocean E-VIP mobile shower and toilet commode with tilting function. Mobile shower and toilet commode with tilting function

    FDA Enforcement
    Class II ·Terminated·Invacare Corporation·November 13, 2013