BEUDAMED
    337 results · 50ms · Sources: EU EUDAMED, US FDA

    Get notified when this changes

    We'll email you when new records match this search — new devices, new clearances, certificate changes, or withdrawals.

    ZOE MEDICAL, INC.

    FDA registration
    ZOE MEDICAL, INC.·5 products·🇺🇸 United States

    NIGHTINGALE PPM (M6)

    FDA Adverse Event
    Malfunction ·ZOE MEDICAL, INC.·Product code MHX·January 5, 2004

    WELL@HOME SYSTEM

    FDA Adverse Event
    Malfunction ·ZOE MEDICAL, INC·Product code DXN·June 18, 2013

    ULTRAVIEW DM3

    FDA Adverse Event
    Malfunction ·ZOE MEDICAL, INC.·Product code DXN·July 11, 2023

    ULTRAVIEW DM3

    FDA Adverse Event
    Malfunction ·ZOE MEDICAL, INC.·Product code DXN·December 29, 2020

    NIGHTINGALE

    FDA Adverse Event
    Malfunction ·ZOE MEDICAL, INC.·Product code MWI·August 12, 2023

    ULTRAVIEW

    FDA Adverse Event
    Malfunction ·ZOE MEDICAL, INC.·Product code DXN·March 30, 2021

    Zee Clear Vinyl Medical Examination Gloves, Powder Free, Large, Non-Sterile; 100 gloves per box, 10 boxes per case; Distributed by Zee Medical, Inc., Irvine, CA 92606, Made in China; Zee Part No.: 3062 Single Use, medical exam glove worn on the hand to provide a barrier against potentially infectious materials and other contaminants

    FDA Recall
    Terminated ·Cypress Medical Products LLC·Product code LYZ·November 15, 2011

    Zee Clear Vinyl Medical Examination Gloves, Powder Free, X-Large, Non-Sterile; 100 gloves per box, 10 boxes per case; Distributed by Zee Medical, Inc., Irvine, CA 92606, Made in China; Zee Part No.: 3063 Single Use, medical exam glove worn on the hand to provide a barrier against potentially infectious materials and other contaminants

    FDA Recall
    Terminated ·Cypress Medical Products LLC·Product code LYZ·November 15, 2011

    Zee Clear Vinyl Medical Examination Gloves, Powder Free, Medium, Non-Sterile; 100 gloves per box, 10 boxes per case; Distributed by Zee Medical, Inc., Irvine, CA 92606, Made in China; Zee Part No.: 3061 Single Use, medical exam glove worn on the hand to provide a barrier against potentially infectious materials and other contaminants

    FDA Recall
    Terminated ·Cypress Medical Products LLC·Product code LYZ·November 15, 2011

    Affected Pain Control Tray Component (5% Lidocaine Hydrochloride and 7.5% DExtrose Injection, USP) Injection of anesthetics to provide regional anesthesia

    FDA Enforcement
    Class II ·Terminated·B. Braun Medical, Inc.·November 9, 2016

    Symbiq Two Channel Infuser; an Rx medical device infusion pump used to administer I.V. fluids; Hospira, Inc., Lake Forest, IL 60045 USA, Made in Costa Rica; List Number 16027-01 Device is a general purpose infusion pump designed to deliver fluids, solutions, medications, agents, nutritionals, electrolytes, blood and blood products for parenteral, enteral, intravenous, intra-arterial, subcutaneous, epidural

    FDA Enforcement
    Class I ·Terminated·Hospira Inc.·October 31, 2012

    Symbiq One Channel Infuser; an Rx medical device infusion pump used to administer I.V. fluids; Hospira, Inc., Lake Forest, IL 60045 USA, Made in Costa Rica; List Number 16026-01 Device is a general purpose infusion pump designed to deliver fluids, solutions, medications, agents, nutritionals, electrolytes, blood and blood products for parenteral, enteral, intravenous, intra-arterial, subcutaneous, epidural

    FDA Enforcement
    Class I ·Terminated·Hospira Inc.·October 31, 2012

    Hospira LifeShield Latex-Free 100 mL Burette Set, Convertible Pin, 77 inch with 2 Prepierced Injection Sites and Option-Lok Microdrip Soluset with Calibrated Burette and Precision Drip Chamber; an Rx sterile medical device used to administer fluids; 20 individually wrapped sets per case; Made in Costa Rica, Hospira, Inc., Lake Forest, IL 60045 USA; list 12722-65. Intended use: for the administration of fluids.

    FDA Enforcement
    Class II ·Terminated·Hospira Inc.·August 1, 2012

    MediChoice¿ Rayon Tipped OB/GYN Applicator, 8 inch, Plastic Shaft, Non-Sterile, Item Numbers WOD5001 and WOD5002. Product Usage: Usage: An absorbent tipped applicator is a device intended for medical purposes that consists of an absorbent swab on a wooden, paper, or plastic stick. The device is used to apply medications to, or to take specimens from, a patient.

    FDA Enforcement
    Class II ·Terminated·Owens & Minor Distribution, Inc.·May 8, 2013

    CADD-Legacy 1, Model 6400 Ambulatory Infusion Pump, REF 21-6400-51, PC 10008552-001, Smiths Medical ASD, Inc. Rx ONLY

    FDA Enforcement
    Class II ·Terminated·Smiths Medical ASD Inc.·January 10, 2018

    Convatec Flexi Seal Control Fecal Management System Rx Only REF 411107 Product Usage:For use to manage fecal incontinence through the collection of liquid to semi-liquid stool and to provide access to administer medications as prescribed by a physician.

    FDA Enforcement
    Class I ·Terminated·Convatec Inc.·June 25, 2014

    DRX-Revolution Mobile X-Ray System, MODEL DRXR-1, Service Code 1243, Catalog Number 1060177 (China) and 1019397 (all other countries) --- Carestream Health, Inc. The DRX-Revolution Mobile X-Ray System is a mobile imaging system that incorporates a self contained x-ray generator, image receptor, imaging display and software for acquiring medical diagnostic images outside of a standard x-ray room. The DRX-Revolution Mobile X-Ray System has a motor for driving the system so that the operator does not have to push the system, but can walk behind the system while it is moving from one location to another.

    FDA Enforcement
    Class II ·Terminated·Carestream Health Inc·December 24, 2014

    Philips brand IntelliSpace PACS 4.4, Image Management System; The system is a software package used with general purpose computing hardware to acquire, store, distribute, process and display images and associated data throughout a clinical environment. Product is manufactured and distributed by Philips Healthcare Informatics, Inc. Foster City, CA IntelliSpace PACS are image management systems intended to be used by trained professionals, including but not limited to physicians, nurses and medical technicians. The system is a software package used with general purpose computing hardware to acquire, store, distribute, process and display images and associated data throughout a clinical environment. The software performs digital image processing, measurement, communication and storage. iSite supports receiving, sending, printing, storing and displaying studies received from the following modality types via DICOM: CT, MR, NM, US, XA, PET, DX, DR, RE, RT, MG, SC, VL, as well as hospital/radiology information systems.

    FDA Enforcement
    Class II ·Terminated·Philips Healthcare Informatics, Inc.·November 20, 2013

    DRX-Revolution Mobile X-Ray System, MODEL DRXR-1, Service Code 1243, Catalog Number 1060177 (China) and 1019397 (all other countries) --- Carestream Health, Inc. The DRX-Revolution Mobile X-Ray System is a mobile imaging system that incorporates a self contained x-ray generator, image receptor, imaging display and software for acquiring medical diagnostic images outside of a standard x-ray room. The DRX-Revolution Mobile X-Ray System has a motor for driving the system so that the operator does not have to push the system, but can walk behind the system while it is moving from one location to another.

    FDA Recall
    Terminated ·Carestream Health Inc·Product code IZL·November 25, 2014