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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.

ARTIS Q, Interventional Fluroscopic x-ray system

FDA Enforcement
Class II ·Terminated·Siemens Medical Solutions USA, Inc·March 29, 2017

Infant Warmer System (IWS)

FDA Enforcement
Class II ·Terminated·GE Healthcare, LLC·January 18, 2017

Terumo Glidesheath (tm), 6 French, Nitinol wire, product code 15-1060. Used to facilitate placing a catheter through the skin into a vein or artery.

FDA Enforcement
Class II ·Terminated·Terumo Medical Corporation·July 3, 2013

Amplatz Stiff Wire Guide

FDA Enforcement
Class II ·Terminated·Cook Inc.·March 21, 2018

Portex LineDraw Arterial Blood Sampling Syringe with Dry Lithium Heparin for Gases and Electrolytes

FDA Enforcement
Class II ·Terminated·Smiths Medical ASD, Inc.·April 22, 2020

Medstream 81" (206 cm) 20 drop Universal Administration Sets. Disposable IV infusion set with 3 year expiration date.

FDA Enforcement
Class II ·Terminated·US Infusion Inc dba Trucare Biomedix-USA·March 25, 2015

Merge Cardio software using EchoIMS. The firm name on the label is Merge Healthcare, Hartland, WI.

FDA Enforcement
Class II ·Terminated·Merge Healthcare, Inc.·March 29, 2017

Medline E-Z Lubricating Jelly; Bacteriostatic. Water Soluble. Sterile. 2 FL OZ (59 ml). Product Usage: For medical purposes to lubricate body orifices to facilitate entry of diagnostic or therapeutic devices. Single use only. Sterile if unopened, undamaged package.

FDA Enforcement
Class II ·Terminated·MEDLINE IND·January 18, 2017

OneStep CPR Complete, Adult Multi Function Electrodes, Part Numbers: 8900 0214 01 (case of 8 single electrodes, UDI: 10847946016279) and 8900 0224 01 (single electrode, UDI: 00847946016272) Product Usage: Intended Use: Defibrillation, Cardioversion, Noninvasive Pacing, EGG Monitoring, CPR Sensor. For use with ZOLL¿ Defibrillators: R Series, M Series. By Trained Personnel only, Including: Physicians, Nurses, Paramedics, Emergency Medical Technicians, Cardiovascular Laboratory Technicians.

FDA Enforcement
Class II ·Terminated·ZOLL Medical Corporation·March 21, 2018

Brand Name: Intermate Infusion Pump. Indicated for the intravenous administration of medications.

FDA Enforcement
Class II ·Terminated·Baxter Healthcare Corp.·July 3, 2013