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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.

Affixus Hip Fracture Nail, RH 125 DEG 9MM X 440MM

FDA Enforcement
Class II ·Terminated·Zimmer Biomet, Inc.·February 7, 2018

Kimberly Clark Patient Warming System - Model 1000 Control Unit. Kimberly Clark Patient Warming System - Model 1000 Control Unit and Energy Transfer Pads is a thermal regulating system, indicated for monitoring and controlling patient temperature.

FDA Enforcement
Class II ·Terminated·Kimberly-Clark Corporation·August 15, 2012

PRO-STIM 10cc INJECTABLE, Part Number 86SR0410

FDA Enforcement
Class II ·Terminated·Wright Medical Technology, Inc.·December 4, 2019

Regard, Item Number: 800422003, Sterile, OR0491C - Arthroscopy Pk - Spohn

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

Response 5.5/6.0 Spine System 7.0mm x 40mm Pedicle Screw Product Usage: Posterior non-cervical pedicle screw fixation

FDA Enforcement
Class II ·Terminated·OrthoPediatrics Corp·February 21, 2018

Affixus Hip Fracture Nail, LH 130 DEG 13MM X 460MM

FDA Enforcement
Class II ·Terminated·Zimmer Biomet, Inc.·February 7, 2018

AngioDynamics Angiographic catheter --- Soft-Vu (JB-1) Non-braided. --- Size: 5F; Length: 100cm; designed to accept guidewire: .035 in. --- Catalog No. [REF]: 10734201. Packaged in boxes of 5 catheters each, with manufacturer listed as AngioDynamics, Inc., Queensbury, NY USA. Intended use: angiographic diagnosis.

FDA Enforcement
Class II ·Terminated·Angiodynamics Worldwide Headquarters·August 15, 2012

BALL NOSE GUIDE WIRE 80CM, 100CM. Item Nos. 281001080 281001100 Product Usage: These instruments and delivery systems are used to facilitate implantation of orthopedic medical devices.

FDA Enforcement
Class II ·Terminated·Zimmer Biomet, Inc.·December 4, 2019

Model 731 EMV+ Uni-Vent, Impact Instrumentation Inc., 27 Fairfield Place, West Caldwell NJ 07006. Indicated for use in the management of acute or chronic respiratory failure or during resuscitation by providing continuous positive -pressure ventilation.

FDA Enforcement
Class III ·Terminated·Impact Instrumentation, Inc.·August 15, 2012

Affixus Hip Fracture Nail, RH 125 DEG 9MM X 260MM

FDA Enforcement
Class II ·Terminated·Zimmer Biomet, Inc.·February 7, 2018