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

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    Filters FDA Enforcement × Status: Terminated × Clear all

    UP & UP kids' power toothbrush

    FDA Enforcement
    Class II ·Terminated·Ranir Corporation·January 29, 2014

    AVANOS MIC-KEY SF Gastrostomy Feeding Tube

    FDA Enforcement
    Class II ·Terminated·Avanos Medical, Inc.·September 23, 2020

    ENNOVATE MIS REMOVALKEY SHORT, product code SZ380R

    FDA Enforcement
    Class II ·Terminated·Aesculap Implant Systems LLC·July 27, 2022

    Fresenius 2008T Series Hemodialysis System

    FDA Enforcement
    Class II ·Terminated·Fresenius Medical Care Renal Therapies Group, LLC·January 25, 2017

    Fresenius 2008K Series : Hemodialysis System

    FDA Enforcement
    Class II ·Terminated·Fresenius Medical Care Renal Therapies Group, LLC·January 25, 2017

    Fresenius 2008K2 Series : Hemodialysis System

    FDA Enforcement
    Class II ·Terminated·Fresenius Medical Care Renal Therapies Group, LLC·January 25, 2017

    Fresenius 2008K@home Series : Hemodialysis System

    FDA Enforcement
    Class II ·Terminated·Fresenius Medical Care Renal Therapies Group, LLC·January 25, 2017

    TopCare Clifford THE BIG RED DOG power toothbrush for kids!

    FDA Enforcement
    Class II ·Terminated·Ranir Corporation·January 29, 2014

    Graseby 3300 Pump and Graseby 3000 Series Pump Accessories Patient controlled syringe pump. Use for Infusion

    FDA Enforcement
    Class II ·Terminated·Smiths Medical ASD Inc.·February 7, 2018

    STOPCON Suction Valve-Suction Valve for GI-Endoscope DISTRIBUTED BY: KEY SURGICAL 8101 WALLACE ROAD / EDEN PRAIRIE, MN 55344 / USA Product Code: EN10232

    FDA Enforcement
    Class II ·Terminated·GA HEALTH COMPANY LIMITED·December 30, 2020

    Outlook ES pump is intended for use with B. Braun Medical Inc. Horizon Pump IV Sets. Used to regulate the flow of primary and secondary fluids when positive pressure is required. The infusion system is capable of delivering fluid from a negative head height (when the IV fluid container is lower than the pump), and provides clinically accepted volumetric accuracy for all standard IV fluids, including blood, lipid, and Total Parenteral Nutrition (TPN). Model number: 621-100ES, 621-200ES, 621-300ES, and 621-400ES. To deliver a broad range of drugs with use with the B. Braun Medical Inc. Horizon Pump IV Sets.

    FDA Enforcement
    Class II ·Terminated·B Braun Medical, Inc.·September 18, 2013

    Outlook ES pump is intended for use with B. Braun Medical Inc. Horizon Pump IV Sets. Used to regulate the flow of primary and secondary fluids when positive pressure is required. The infusion system is capable of delivering fluid from a negative head height (when the IV fluid container is lower than the pump), and provides clinically accepted volumetric accuracy for all standard IV fluids, including blood, lipid, and Total Parenteral Nutrition (TPN). Model number: 621-100ES, 621-200ES, 621-300ES, and 621-400ES. To deliver a broad range of drugs with use with the B. Braun Medical Inc. Horizon Pump IV Sets.

    FDA Enforcement
    Class II ·Terminated·B Braun Medical, Inc.·September 18, 2013

    STOPCON Disposable Endoscope Valves Set-Single Use Valves Olympus R (Air-Water-/Suction) DISTRIBUTED BY: KEY SURGICAL 8101 WALLACE ROAD / EDEN PRAIRIE, MN 55344 / USA Product Code: EN10229.2

    FDA Enforcement
    Class II ·Terminated·GA HEALTH COMPANY LIMITED·December 30, 2020

    ENNOVATE MIS REMOVALKEY SHORT, product code SZ380R

    FDA Enforcement
    Class II ·Terminated·Aesculap Implant Systems LLC·July 27, 2022

    Ki Mobility, Little Wave Tyke (Weight Limit: 95 lbs), Specifically the IFU The Little Wave Tyke is a manually operated device that can be used for medical purposes and is used to assist a disabled person to move from one place to another while sitting. Intended to be used by persons up to 95 pounds for transport.

    FDA Enforcement
    Class III ·Terminated·Ki Mobility Llc·January 19, 2022

    STOPCON Disposable Valves Set-Single Use Valves (suction-/air-water-/biopsy-valve/auxiliary water connector) DISTRIBUTED BY: KEY SURGICAL 8101 WALLACE ROAD / EDEN PRAIRIE, MN 55344 / USA Product Code: EN10229.1

    FDA Enforcement
    Class II ·Terminated·GA HEALTH COMPANY LIMITED·December 30, 2020

    Hand Foot II, UVB-138. One device per box; device is surrounded by foam inserts inside a corrugated box. For UV phototherapy treatment.

    FDA Enforcement
    Class II ·Terminated·National Biological Corp·April 5, 2017

    Arctic Sun 5000 and Arctic Sun 2000; Intended for monitoring and controlling patient temperatures.

    FDA Enforcement
    Class II ·Terminated·C.R. Bard, Inc.·February 17, 2016

    NICO Shepherd' s Hook - Greenberg, sterile. An accessory to NICO s BrainPath device Part Number: NN-8024

    FDA Enforcement
    Class II ·Terminated·Nico Corp.·August 22, 2018

    STOPCON Disposable Valves Set-Single Use Single Use Valves Olympus R (Air-Water-/Suction-/ Biopsy-Valve) DISTRIBUTED BY: KEY SURGICAL 8101 WALLACE ROAD / EDEN PRAIRIE, MN 55344 / USA Product Code: EN10229

    FDA Enforcement
    Class II ·Terminated·GA HEALTH COMPANY LIMITED·December 30, 2020