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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.

16CM MIN INVASIVE ATTACH, BLACK MAX

FDA Enforcement
Class II ·Terminated·The Anspach Effort, Inc.·May 10, 2017

Emerald Diluent Tubing, List number 09H50-01, accompanying CELL-DYN Emerald instrument, List number 09H39-01. The firm name on the label is Abbott Laboratories, Abbott Park, IL.

FDA Enforcement
Class II ·Terminated·Abbott Laboratories·October 30, 2019

Varian brand Clinac, Trilogy, Novalis Tx, Unique, linear accelerators; Model Number: H14, H18, H29, Reference/FSCA Identifier: CP-08881; Product is manufactured and distributed by Varian Medical Systems Inc., Palo Alto, CA. 1) The Varian Low Energy Linear Accelerator is indicated for precision radiotherapy for lesions, tumors and conditions anywhere in the body when radiation treatment i is indicated. (2) The Varian High Energy Linear Accelerator is indicated for stereotactic radiosurgery and precision radiotherapy for lesions, tumors and conditions anywhere in the body when radiation treatment is indicated.

FDA Enforcement
Class II ·Terminated·Varian Medical Systems, Inc. Oncology Systems·September 26, 2012

Cooper Surgical Incontinence Dish Folding Pessary #0, 55mm. Milex Part Number: MXPCOND00 A pessary is a medical device that is inserted into the vagina to function as a supportive structure of the uterus and/or bladder and rectum.

FDA Enforcement
Class III ·Terminated·Cooper Surgical, Inc.·April 3, 2013

Giraffe OmniBed Ohmeda Medical Omnibed- The OmniBed is a combination of an infant incubator ( incubator ) and an infant radiant warmer ( warmer ). Incubators and warmers provide heat in a controlled manner to neonates who are unable to thermo-regulate based on their own physiology. Incubators provide an enclosed, temperature controlled environment and warmers provide infrared heat in an open environment. They may also be used for short periods of time to facilitate the neonate s transition from the uterus to the external environment

FDA Enforcement
Class II ·Terminated·Ohmeda Medical·March 29, 2017

BD Spinal Anesthesia Tray The BD Spinal Anesthesia Tray is intended for use by professional anesthesiologists to perform the spinal anesthesia procedure

FDA Enforcement
Class II ·Terminated·Becton Dickinson & Company·December 21, 2016

System Console, Single Port, no irrigation

FDA Enforcement
Class II ·Terminated·The Anspach Effort, Inc.·May 10, 2017

Panta Nail, Rx only, Sterile,

FDA Enforcement
Class II ·Terminated·Integra LifeSciences Corp.·March 29, 2017

7.5CM ANGLE ATTACHMENT, BLACK MAX

FDA Enforcement
Class II ·Terminated·The Anspach Effort, Inc.·May 10, 2017

KIMGUARD Container Filters, 7.5in (19cm), Round and 9in. X 9in. (23cm x 23cm), Square. Intended to be used to enclose another medical device that is to be sterilized by a health care provider.

FDA Enforcement
Class II ·Terminated·Kimberly-Clark Corporation·April 3, 2013