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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.

Difco" Agar Noble, 500g bottle Noble Agar is a solidifying agent that is essentially free of impurities. It is used in electrophoretic and nutritional procedures and in preparing microbiological culture media when increased purity is required.

FDA Enforcement
Class II ·Terminated·Becton Dickinson & Co.·March 21, 2018

Turbo Elite Atherectomy Catheter. Models: 410-152, 410-154, 414-151, 414-159, 417-152, 417-156, 420-006, 420-159, 423-001, 423-135-01 The Laser Catheters are used in conjunction with the Spectranetics CVX-300¿ Excimer Laser System and are intended for use in patients with single or multivessel coronary artery disease, either as a stand-alone modality or in conjunction with Percutaneous Transluminal Coronary Balloon Angioplasty (PTCA), and who are acceptable candidates for coronary artery bypass graft (CABG) surgery.

FDA Enforcement
Class II ·Terminated·Spectranetics Corporation·December 7, 2016

Regard, Item Number: 800562001, Sterile, NU0651A - Neuro - Childrens Santa Rosa

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

CPT 12/14 COCR SIZE 1 EXT prosthesis, hip, semi-constrained, metal/polymer, porous uncemented

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

Regard, Item Number: 800091002, Sterile, LD0692B - C Section - FMOL Lady of Angels

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

ArrowADVANTAGE 5 Pressure Injectable Peripherally Inserted Central Catheter (PICC). Product Codes: PR-35041-HPHNM and CDA-35041-HPK1A.

FDA Enforcement
Class II ·Terminated·Arrow International Inc·February 21, 2018

Hamilton-MR1 Ventilator: Catalog# 161010 The Hamilton MR1 Ventilator is intended to provide pressure ventilator support to adults and pediatrics, and optionally infants and neonates. Intended areas of use include: MRI Dept., Intensive, intermediate, emergency and long-term acute care as well as transfer of patients within a hospital.

FDA Enforcement
Class II ·Terminated·Hamilton Medical, Inc.·December 7, 2016

CORAIL COXA VARA HIGH OFFSET STEM Collared Size 9

FDA Enforcement
Class II ·Terminated·DePuy Orthopaedics, Inc.·February 21, 2018

AFX Endovascular AAA System, Endoleak Type IIIA Product Usage: The AFX Endovascular AAA System is intended for endovascular treatment of patients with abdominal aortic or aortoiliac aneurysms (AAA).

FDA Enforcement
Class II ·Terminated·Endologix·January 25, 2017

Double Flexible Tipped Wire Guide

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