BEUDAMED
    126 results · 10ms · Sources: EU EUDAMED, US FDA

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    Filters FDA Enforcement × Status: Terminated × Clear all

    Algerbrush-II Product Usage: Medical - For surgeons to use in ophthalmic surgical procedures to remove foreign bodies from the eye of the patient

    FDA Enforcement
    Class II ·Terminated·Bausch & Lomb, Inc.·January 18, 2017

    Bausch & Lomb, Biotrue, Multi-purpose contact lens solution, 10 fl.oz., Sterile.

    FDA Enforcement
    Class II ·Terminated·Bausch & Lomb Inc- Greenville Solutions Plant·May 14, 2014

    Bivona Aire-Cuf Endotracheal Tube

    FDA Enforcement
    Class II ·Terminated·Smiths Medical ASD Inc.·November 3, 2021

    Bivona Uncuffed Wire Endotracheal Tubes,

    FDA Enforcement
    Class II ·Terminated·Smiths Medical ASD Inc.·November 3, 2021

    Sit/stand Rolling Walker, SKU/Item Number 66838. Intended for use by those with difficulty walking and weighing 225 lbs. or less.

    FDA Enforcement
    Class II ·Terminated·Central Purchasing LLC DBA Harbor Freight Tools·April 16, 2014

    SUNSTAR G.U.M PERIOSHIELD Oral Health Rinse, 300mL, SKU numbers 1775P, 1775R - Product Usage: Help prevent and treat gingivitis caused by plaque build up Significantly reduce bleeding gums Protect teeth and gums from plaque causing bacteria.

    FDA Enforcement
    Class II ·Terminated·Sunstar Americas, Inc.·June 16, 2021

    Ameda One-Hand Manual Breast Pump (SKU 17161) - Primary packaging is 6 pouches with Tyvek header (9.5 x 13.63 x 3.75") within a secondary corrugated shipper (16 x 11.02 x 5.12" inner dimensions). The device is indicated for assisted expression of milk using manual suction.

    FDA Enforcement
    Class II ·Terminated·Ameda, Inc.·April 1, 2015

    First Aid Kits containing acetaminophen under brand names Equate (Walmart), Meijer, and Care Science (Amazon)

    FDA Enforcement
    Class II ·Terminated·ASO LLC·May 11, 2022

    Relief ACP Oral Care Gel intended to relieve discomfort from dentin sensitivity. Sold separately in single, single syringe, 4 packs, 6 packs and in teeth whitening kits

    FDA Enforcement
    Class II ·Terminated·Discus Dental LLC·December 3, 2014

    Ameda Dual Short Term HygieniKit Milk Collections System (SKU 17115) - Primary packaging is 12 pouches with Tyvek header (10.75 x 16.375 x 3") within a secondary corrugated shipper (20.75 x 15.50 x 8.5" inner dimensions). The device is intended to be connected to a powered breast pump or adapted for use with a manual breast pump to express and collect the mother's milk of a nursing woman for the purpose of feeding the collected milk to a baby.

    FDA Enforcement
    Class II ·Terminated·Ameda, Inc.·April 1, 2015

    ChemoPlus Drug Spill Kit-INSTI, SKU DP5016K

    FDA Enforcement
    Class II ·Terminated·Cardinal Health 200, LLC·February 17, 2021

    CHEMOPLUS DRUG SPILL KIT HOS, SKU CT4004

    FDA Enforcement
    Class II ·Terminated·Cardinal Health 200, LLC·February 17, 2021

    Rifton E-Pacer, SKU K660, powered lift device

    FDA Enforcement
    Class II ·Terminated·Community Products, LLC·October 30, 2019

    Covidien ChemoPlus Chemo Spill Kit, Nonsterile, SKU DP5108K

    FDA Enforcement
    Class II ·Terminated·Cardinal Health 200, LLC·February 17, 2021

    DeVilbiss Vacu-Aide QSU Suction Unit (Disposable Suction Container/Filter), 800 ML DISP Container, Unassembled, 800 ML DISP Container w/6' patient tubing, and 800 ML DISP Container w/6' patient tubing, assembled. DeVilbiss Vacu-Aide QSU Suction Unit (Disposable Suction Container/Filter) is used to remove fluids from the airway or respiratory support system and infectious materials from wounds. It is available for use by consumers by physician order.

    FDA Enforcement
    Class II ·Terminated·DeVilbiss Healthcare LLC·October 9, 2013

    Contour Next Control Solution for Contour Next Blood Glucose Test System. Liquid quality control solution. Plastic bottle, 2.5mL. Indicated for use with fresh fingertip capillary whole blood samples.

    FDA Enforcement
    Class II ·Terminated·Bayer Healthcare, LLC·September 9, 2015

    Rifton TRAM Low Base, SKU K320, powered lift device

    FDA Enforcement
    Class II ·Terminated·Community Products, LLC·October 30, 2019

    Rifton TRAM Standard Base, SKU K310, powered lift device

    FDA Enforcement
    Class II ·Terminated·Community Products, LLC·October 30, 2019

    SUNSTAR Butler Clear Dip, 16 FL OZ, SKU #716PA

    FDA Enforcement
    Class II ·Terminated·Sunstar Americas, Inc.·April 21, 2021

    Gibco GlutaMAX Supplement, for In-Vitro Diagnostic Use SKU 35050061

    FDA Enforcement
    Class II ·Terminated·Life Technologies, Corp.·October 24, 2018