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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.

GE Healthcare Innova 2121IQ. Angiographic X-ray systems used in generating fluoroscopic and rotational images of human anatomy for diagnostic, interventional and image-guided surgical procedures.

FDA Enforcement
Class II ·Terminated·GE Healthcare·July 8, 2015

Custom procedure trays containing medical components needed to facilitate patient procedures and to perform minor and major patient surgeries. Multiple item and lot numbers.

FDA Enforcement
Class II ·Terminated·Avid Medical, Inc.·March 25, 2020

Regard, Item Number: 800408004, Sterile, LD0477D - C-Section PK - Spohn

FDA Enforcement
Class II ·Terminated·Resource Optimization & Innovation Llc·April 5, 2017

Presource Kit Total Joint Pack containing a double-wrapped basin component. Product Usage: This kit is used on patients undergoing joint replacement knee or hip.

FDA Enforcement
Class II ·Terminated·Cardinal Health Inc.·January 16, 2019

Regard, Item Number: 880327009, Sterile, CV0758I - Open Heart A&B - OSU

FDA Enforcement
Class II ·Terminated·Resource Optimization & Innovation Llc·April 5, 2017

EXPRESS Dry Seal Chest Drain, Single Collection P/N: 4000-100N

FDA Enforcement
Class II ·Terminated·Atrium Medical Corporation·July 8, 2015

BacT/ALERT SA Blood Culture Bottle. The BacT/ALERT SA reagent bottle is intended to be recover and detect aerobic microorganisms (bacteria and fungi) from blood and other normally sterile body fluids.

FDA Enforcement
Class II ·Terminated·bioMerieux, Inc.·February 6, 2013

HydroDot brand: Wave Prep Single use cups, 8.5 gm (0.3 oz) 24/box-Product 1700-24 - Product Usage: An electroconductive cream for use with external electrodes to reduce the impedance of the contact between the electrode surface and the skin. The cream is not intended for use with stimulating electrodes.

FDA Enforcement
Class II ·Terminated·Bio-Signal Group Corp.·December 25, 2019

Palindrome Precision HSI Chronic Catheter Sport Pack w/VenaTrac Stylet 14.5 Fr x 28cm Item Code: 8888128459P

FDA Enforcement
Class II ·Terminated·Covidien LLC·July 8, 2015

BioFlo PICC with ENDEXO Technology and PASV Valve Technology Maximal Barrier Nursing Kit, 5F-55 cm, UPN Product No. H965750191, REF/Catalog No. 75-019, STERILE --- Indicated for short or long-term peripheral access to the central venous system for intravenous therapy, including but not limited to, the administration of fluids, medications, nutrients; the sampling of blood and for power injection of contrast media.

FDA Enforcement
Class II ·Terminated·Navilyst Medical, Inc·October 15, 2014