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.

DeRoyal(R) Enteral Safe Feed Tube, REF 54-2465 A Nasogastric/Oralgastric enteral feeding tube. The MED-RX Feeding Tube is intended to be used for nasogastric/oralgastric enteral feeding as directed by a physician

FDA Enforcement
Class II ·Terminated·DeRoyal Industries Inc·January 23, 2019

Maximum Variable Pitch Compression Tray Base, Reference Number 231201002 Product Usage: Intended to carry implants and instruments during regular inventory distribution and handling and sterilization in the hospitals

FDA Enforcement
Class II ·Terminated·Zimmer Biomet, Inc.·January 23, 2019

Regard, Item Number: 800526002 Sterile, ET0610B - Head and Neck - Westover Hills

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

Arthrex Suture Anchor, Nano Corkscrew FT (consists of an anchor pre-loaded on a handled inserter including suture, with needles.) Part Number AR-1317FT Product Usage: Soft tissue fixation to bone in the hand and wrist

FDA Enforcement
Class II ·Ongoing·Arthrex, Inc.·January 23, 2019

iTotal Hip Replacement System, Total Hip Replacement System, Catalog Number HAA-050-D001-020101

FDA Enforcement
Class II ·Terminated·Conformis, Inc.·January 23, 2019

Upper Right Telescope Unibodies (5/pk) and Upper Left Telescope Unibodies (54/pk) A Herbst Appliance is used to affect changes in the skeletal relationship and/or occlusion of a patient. the Universal Nut is a component of a Herbst Appliance.

FDA Enforcement
Class II ·Terminated·Specialty Appliance Works, Inc.·April 29, 2015

"J" Type Bone Marrow Needle 11ga x 10 cm - Product Usage: Manual surgical instruments for Bone Marrow Biopsy and Aspiration.

FDA Enforcement
Class II ·Terminated·Angiotech (Manan Medical Products, Inc.)·February 13, 2019

Juno DRF , X-ray system, diagnostic, Fluoroscopic, general-purpose Model: 70920 Product Usage: Universal R/F, general use

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

CVS Health At Home A1C Test Kit, Software Version Revision D, REF Number 3059

FDA Enforcement
Class II ·Terminated·Polymer Technology Systems·December 25, 2019

Regard, Item Number: 800599001, Sterile, GS0694A - Robotic Lap - Christus Highland

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