BEUDAMED
    367 results · 18ms · 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.
    Filters FDA Recall ×

    McKesson Horizon Medical Imaging (HMI) products versions 4.6.1 to including 11.9 and McKesson Radiology (MR) products 12.0 and 12.1.1.

    FDA Recall
    Terminated ·Mckesson Medical Immaging Suite 130-10711 Cambie Road Richmond Canada British Columbia·Product code LLZ·February 18, 2016

    WHILL Model C2, with software versions before HMI: 2.22 / MC: 1.13; device is an indoor/outdoor battery-operated 2-wheel drive (rear-wheel drive) powered wheelchair.

    FDA Recall
    Open, Classified ·WHILL, INC. 2 Chome 1-11 Higashishinagawa Shinagawa Japan·Product code ITI·December 29, 2025

    WHILL Model F, with software versions before HMI: 2.23 / MC: 1.05; the device is an indoor/outdoor, foldable battery-operated 2-wheel drive (rear-wheel drive) powered wheelchair.

    FDA Recall
    Open, Classified ·WHILL, INC. 2 Chome 1-11 Higashishinagawa Shinagawa Japan·Product code ITI·December 29, 2025

    McKesson Horizon Medical Imaging (HMI) Radiological Image Processing System, product versions 4.6.1 to 11.6., is a medical image and information management application intended to receive, transmit, store, retrieve, display, print and process digital medical images, digital medical video, and associated medical information from medical imaging systems.

    FDA Recall
    Terminated ·Mckesson Information Solutions LLC·Product code LLZ·September 4, 2013

    Minor Surgical Kits, Sterile-Kits containing the Devon Light Glove Catalog Numbers/Description: 573208 7519-DHCG MINOR KIT 573210 7581-CSD Minor KIT 573741 7667-HMI Minor Kit 31144507 7519 Minor Surgical Kit 573830D MINOR KIT

    FDA Recall
    Terminated ·Covidien LLC·Product code FSY·April 16, 2015

    Horizon Medical Imaging versions 11.5, 11.5.1, 11.5.2, 11.6, 11.7 and 11.8. Horizon Medical Imaging is a medical image and information management application that is intended to receive, transmit, store, retrieve, display, print and process digital medical images, digital medical video, and associated medical information from various medical imaging systems.

    FDA Recall
    Terminated ·Mckesson Information Solutions LLC·Product code LLZ·February 2, 2011

    Hamilton-C6

    FDA Recall
    Open, Classified ·Hamilton Medical AG Parc Industrial Vial 10 Domat/Ems Switzerland·Product code CBK·September 22, 2022

    MAQUET CARDIOHELP Support System: CARDIOHELP-I Software (up to version 3.3.0.0) Product Usage: The Cardiohelp System is a blood oxygenation and carbon dioxide removal system used to pump blood through the extracorporeal bypass circuit for circulatory and/or pulmonary support during procedures requiring cardiopulmonary bypass (for periods up to six hours). It is also intended to provide circulatory and/or pulmonary support during procedures not requiring cardiopulmonary bypass (for periods up to six hours).

    FDA Recall
    Terminated ·Maquet Cardiovascular, LLC·Product code DTQ·March 7, 2013

    Horizon Medical Imaging It is a medical image and information management application that is intended to receive, transmit, store, retrieve, display print and process digital medical images, digital medical video, and associated medical information from various medical imaging systems.

    FDA Recall
    Terminated ·Mckesson Medical Immaging Suite 130-10711 Cambie Road Richmond Canada British Columbia·Product code LLZ·May 5, 2014

    MAQUET Getinge Group CARDIOHELP Base Unit REF 70104.7999 REF 70104.8012 Manufactured for: MAQUET Cardiopulmonary AG Made in Germany. Cardiopulmonary support system.

    FDA Recall
    Terminated ·Maquet Medical Systems USA·Product code DTQ·September 12, 2013

    BD Microkeratome K3000 and K4000;Catalog Number: 378660, Becton Dickinson & Company (BD)

    FDA Recall
    Terminated ·Becton Dickinson and Company·Product code HMY·August 9, 2007

    BD K-3000 Microkeratome Blade REF 378607

    FDA Recall
    Terminated ·BD Opthalmic Systems·Product code HMY·January 24, 2003

    ANCILLARY ADULT 140-DOSE CONVENIENCE KIT, ITEM #1189482, for the administration of the Moderna COVID-19 vaccine convenience kit for the administration of the COVID-19 vaccine

    FDA Recall
    Terminated ·Mckesson Medical-Surgical Inc. Corporate Office 9954 Maryland Drive Deep Run Iii Ste. 4000 Richmond VA 23233·Product code QMT·June 2, 2021

    Medacta AMIS Universal Table for Leg Positioner, Model Number: 01.15.10.0172. The AMIS universal table for leg positioner and AMIS Leg Positioner are used during Anterior Minimally Invasive Surgery for hip arthroplasty. The system aids the surgical procedure by providing support and alignment of the limb.

    FDA Recall
    Terminated ·Medacta Usa Inc·Product code FWX·May 21, 2008

    AortaScan AMI 9700 The AortaScan AMI 9700 is an ultrasound device that projects ultrasound energy into the mid-abdomen to obtain an image of the abdominal aorta for aortic diameter measurements

    FDA Recall
    Terminated ·Verathon, Inc.·Product code IYO·August 23, 2010

    Ami HTX.

    FDA Recall
    Open, Classified ·Spectral Instruments Inc·Product code RCE·May 13, 2025

    Am I Pregnant? One Step HCG Pregnancy Test REF 100-17

    FDA Recall
    Open, Classified ·Universal Meditech Inc.·Product code LCX·May 22, 2023

    I-Flow ON-Q PainBuster (100 ml, 2 mI/hr) Pump, PM012, Lot #662449 and 662742

    FDA Recall
    Terminated ·I-Flow Corporation·Product code MEB·November 29, 2006

    BladderScan BVI 9600, Model Numbers: 0270-0451, 0270-0452, 0270-0754, and U270-0451. AortaScan AMI 9700, Model Numbers: 0270-0636, 0270-0639, and U270-0636.

    FDA Recall
    Terminated ·Verathon, Inc.·Product code IYO·November 30, 2015

    Turbo Troponin I For in vitro diagnostic use for the quantitative measurement of troponin I in serum, heparinized or EDTA plasma, as an aid in the diagnosis of acute myocardial infarction (AMI).

    FDA Recall
    Terminated ·Siemens Healthcare Diagnostics, Inc.·Product code MMI·October 27, 2014