SEO landing

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.

3M Durapore Advanced, Surgical Tape, Model Numbers: 1590-0, 1590-1, 1590-2, 1590-3, 1591-0, 1591-1, 1591-2, 1591-3, 1590S-1, 1590S-2, 1590B-118, 1590B-136

FDA Enforcement
Class II ·Terminated·3M Company - Health Care Business·January 1, 2020

Vanguard XP Tibial Tray 73 mm Item # 195250

FDA Enforcement
Class II ·Terminated·Zimmer Biomet, Inc.·September 18, 2019

BVI Custom Eyes¿ Ophthalmic Procedure Kits with the component -Devon Light Glove Part Number: 584676 Ophthalmic surgical kits

FDA Enforcement
Class II ·Terminated·Beaver-Visitec International Inc.·June 24, 2015

Regard, Item Number: 800508004, Sterile, LD0586D - C Section - Jasper

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

Regard, Item Number: 800430005, Sterile, LD0499E - C Section Pk - Cabrini

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

BVI Custom Eyes¿ Ophthalmic Procedure Kits with the component -Devon Light Glove Part Number: 584648 Ophthalmic surgical kits

FDA Enforcement
Class II ·Terminated·Beaver-Visitec International Inc.·June 24, 2015

Vanguard XP Tibial Tray 63 mm Item # 195245

FDA Enforcement
Class II ·Terminated·Zimmer Biomet, Inc.·September 18, 2019

Regard, Item Number: 800413005, Sterile, CV0482E- Vascular PK - Spohn

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

Vanguard M Unicondylar Tibial Trial For use during knee joint replacement.

FDA Enforcement
Class II ·Terminated·Biomet, Inc.·June 24, 2015

Luxurian. These include all products labeled as UltraSlim, Luxurian, BioSlim Lipo, Cellulize, Slim 'n Trim, UltraRed, UltraBlue, Slim-PRO, Dazzle Light, UltraSlim Cold Light, SlenderRay, and U-Slim It, as well as those products with private labelling branding. Company claims that the product provide non-invasive solutions to improve the appearance of fat accumulations, cellulite, fine lines, wrinkles, skin tone, and blemishes.

FDA Enforcement
Class II ·Terminated·Advanced Photonic Systems, LLC·September 24, 2014