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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, VCT for Discovery VCT, Discovery RX VCT, and Discovery PET/CT 690, Lightspeed VCT, Discovery CT750HD. Intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission.

FDA Enforcement
Class II ·Terminated·GE Healthcare, LLC·May 8, 2013

Regard, Item Number: 800535002 Sterile, LD0620B - C Section - New Braunfels

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

G7 HPLC. Used as an aid in the detection and presumptive identification of abnormal hemoglobins in whole blood.

FDA Enforcement
Class III ·Terminated·Tosoh Bioscience Inc·April 17, 2013

Coons Interventional Wire Guide

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

VMX, VMX Plus Mobile Radiographic Unit with the following models: 45296139; 45296200; 45296350; 45296477; 45296964; 45297001; 45296966; 45297003; 2240169; 2240171; 2240172; 2240173. Product Usage: The VMX is a mobile radiography system incorporating stylish design for totally adapted use in intensive care, emergencies, pediatrics, neonatology and orthopedics.

FDA Enforcement
Class II ·Terminated·GE Healthcare, LLC·April 17, 2013

CPT 12/14 COCR SIZE 0 STD prosthesis, hip, semi-constrained, metal/polymer, porous uncemented

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

St. Jude Medical CONFIRM Rx Insertable Cardiac Monitor, Sterile EO, Model #: DM3500 The Confirm Rx ICM is indicated for the monitoring and diagnostic evaluation of patients who experience unexplained symptoms such as: dizziness, palpitations, chest pain, syncope, and shortness of breath, as well as patients who are at risk for cardiac arrhythmias. It is also indicated for patients who have been previously diagnosed with atrial fibrillation or who are susceptible to developing atrial fibrillation.

FDA Enforcement
Class II ·Terminated·St Jude Medical Inc.·July 11, 2018

Novation Cemented Plus Femoral Stem, 12/14, Collared, Standard Offset, Matte, Cemented, Size 15.

FDA Enforcement
Class II ·Terminated·Exactech, Inc.·January 25, 2017

Regard, Item Number: 800418001, Sterile, GY0487A - Major Vaginal PK - Spohn

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

Zimmer¿ M/L Taper Hip Prosthesis With Kinective¿ Technology Cementless, Size 7.5; 00-7713-007-00

FDA Enforcement
Class II ·Terminated·Zimmer Biomet, Inc.·July 11, 2018