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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.

ELEKTA MOSAIQ SW version below 2.41 Product Usage: The intended use of the SIEMENS branded ARTISTE and ONCOR family of linear accelerator systems is to deliver X-ray photon and electron radiation for the therapeutic treatment of cancer.

FDA Enforcement
Class II ·Terminated·Siemens Medical Solutions USA, Inc·April 17, 2013

CR OPTION FEM COMP SIZE C/L CR OPTION FEM COMP SIZE C/R CR OPTION FEM COMP SIZE D/L CR OPTION FEM COMP SIZE D/R CR OPTION FEM COMP SIZE E/L CR OPTION FEM COMP SIZE E/R CR OPTION FEM COMP SIZE F/L CR OPTION FEM COMP SIZE F/R CR OPTION FEM COMP SIZE G/L CR OPTION FEM COMP SIZE G/R This device is indicated for patients with severe knee pain and disability

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

ACE Trochanteric Nail System STER TROC NAIL 180X11X140 STER TROC NAIL 125 DEG X 11MM STER TROC NAIL 130 DEG X 11MM STER TROC NAIL 135 DEG X 11MM The Trochanteric Nail System is intended to treat stable and unstable proximal fractures of the femur including pertrochanteric fractures, intertrochanteric fractures, high subtrochanteric fractures and combinations of these fractures. The Trochanteric Long Nail System is additionally indicated to treat pertrochanteric fractures associated with shaft fractures, pathologic fractures in osteoporotic bone of the trochanteric and diaphyseal areas, long subtrochanteric fractures, ipsilateral femoral fractures, proximal or distal nonunions and malunions and revision procedures.

FDA Enforcement
Class II ·Terminated·Zimmer Biomet, Inc.·April 4, 2018

The LIFEPAK CR Plus and LIFEPAK EXPRESS defibrillators. Product part's numbers: 3200731-xxx, 3202177-xxx, U3200731-xxx, and U3202177-006. Automated external defibrillators.

FDA Enforcement
Class II ·Terminated·Physio Control, Inc.·April 17, 2013

5mm Endopath Xcel with Optiview Technology, Bladeless Trocar with Stability Sleeve, 5mm, 100mm shaft length, 2B5LT

FDA Enforcement
Class II ·Terminated·Ethicon Endo-Surgery Inc·May 23, 2018

MAHURKAR"* Elite 12 FR x 16cm Acute Dual Lumen Dialysis Catheter with Curved Extensions, IC Trays. Product Number: 8888222316.

FDA Enforcement
Class II ·Terminated·Medtronic Minimally Invasive Therapies Group·March 21, 2018

Movable Core Wire Guide

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

Zimmer¿ M/L Taper Hip Prosthesis With Kinective¿ Technology Cementless, Size 10; 00-7713-010-00

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

Flexible Grip which is part of the Synthes Universal Nail System. Indicated for the conventional (non-locking) technique of treating stable diaphyseal fractures.

FDA Enforcement
Class II ·Terminated·Synthes USA HQ, Inc.·April 17, 2013

Endo GIA" Auto Suture" Universal Articulating Loading Unit 30mm - 3.5mm ( Item Code 030452) Product Usage: The Endo GIA universal and Endo GIA universal XL staplers place two, triple-staggered rows of titanium staples and simultaneously divides the tissue between the two, triple-staggered rows. The size of the staples is determined by the selection of the 2.0 mm, 2.5 mm, 3.5 mm or 4.8 mm single use loading unit. The Endo GIA universal staplers will accommodate any of the single use loading unit sizes that are available in the 30 mm, 45 mm and 60 mm lines.

FDA Enforcement
Class II ·Terminated·COVIDIEN MEDTRONIC·May 23, 2018