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FDA Device Enforcement Reports

View 10000 FDA Device Enforcement Reports on BEUDAMED, the Better Database on Medical Devices. These records compile FDA actions such as recalls, safety alerts, market withdrawals, and warning letters related to medical devices regulated in the United States. Each entry lists device identifiers, manufacturer information, enforcement dates, and the reason for the action to support quick assessment.

FDA Device Enforcement Reports help clinicians, manufacturers, and health-system buyers assess device safety and regulatory status. Use BEUDAMED to monitor trends, compare enforcement activity across device types, and export data for quality and compliance reviews. Regular review of enforcement reports supports post-market surveillance and informed procurement decisions.

Carestream Vue PACS; UPG MX-RAD SVR 7.5K EX/YR UNLIMITED The CARESTREAM PACS is an image management system whose intended use is to provide completely scaleable local and wide area PACS solutions for hospital and related institutions/sites, which will archive, distribute, retrieve and display images and data from all hospital modalities and information systems.

FDA Enforcement
Class II ·Terminated·Carestream Health Inc.·November 20, 2013

Artis zee/ zeego Interventional Fluoroscopic X-Ray System, Model Number: 10094142, Software Version: VC21C

FDA Enforcement
Class II ·Terminated·Siemens Medical Solutions USA, Inc·December 25, 2019

Custom Packs to be used in surgical procedures.

FDA Enforcement
Class II ·Terminated·American Contract Systems·June 10, 2020

Carestream Vue PACS; MX WEB SVR W/3 MX-O LIC< 7.5K EXAMS The CARESTREAM PACS is an image management system whose intended use is to provide completely scaleable local and wide area PACS solutions for hospital and related institutions/sites, which will archive, distribute, retrieve and display images and data from all hospital modalities and information systems.

FDA Enforcement
Class II ·Terminated·Carestream Health Inc.·November 20, 2013

Intera 0.5T Standard, Model 781101 Product Usage: Indicated for use as a diagnostic device. It can produce cross-sectional images, spectroscopic images and/or spectra in any orientation of the internal structure of the head, body,or extremities.

FDA Enforcement
Class II ·Terminated·Philips Electronics North America Corporation·April 25, 2018

microTargeting" Lead Adapter for STar" Drive, Product Number 70-CN-DB

FDA Enforcement
Class II ·Terminated·FHC, Inc.·July 11, 2018

microTargeting" Drive System, Product Number 66-ZD-MD

FDA Enforcement
Class II ·Terminated·FHC, Inc.·July 11, 2018

ILLINOIS (TJ) NEEDLE ASPIRATION [15GA, 18GA]; STERILE;

FDA Enforcement
Class II ·Terminated·Carefusion 2200 Inc·April 25, 2018

MOSAIQ Oncology Information Systems interfaced to Elekta Treatment machines. An image enabled electronic medical record system used for oncology workflow management. Manufactured by: Impac Medical Systems 100 Mathilda Place, 5th floor Sunnyvale, Ca 94086

FDA Enforcement
Class II ·Terminated·Impac Medical Systems Inc·July 18, 2012

LFIT Anatomic CoCr Femoral Heads, Catalog No. 6260-9-044

FDA Enforcement
Class II ·Terminated·Howmedica Osteonics Corp.·July 11, 2018