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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.
ACCU-CHECK FastClix Lancing Device. It is intended for use in conjunction with a blood glucose monitoring system.
FDA Enforcement
Class II
·Terminated·Roche Diagnostics Operations, Inc.·September 4, 2013
Affixus Hip Fracture Nail, RH 130 DEG 11MM X 420MM
FDA Enforcement
Class II
·Terminated·Zimmer Biomet, Inc.·February 7, 2018
Ultrasound Transducer (M2736A), that may have been serviced with the following: Pacific Medical Philips Avalon Smart US/TOCO Cable Assembly, NFPHA9020; Pacific Medical Philips M2736A Avalon Smart Ultrasound Bottom Case, NFPHA9515
FDA Enforcement
Class II
·Ongoing·Pacific Medical Group Inc.·February 19, 2020
Zoll X Series Defibrillator/Pacemaker/Monitor Product Usage: The product is used by qualified medical personnel for the purpose of converting ventricular fibrillation to sinus rhythm or other cardiac rhythms capable of producing hemodynamically significant heart beats. In addition, the product may be used in synchronized mode to terminate certain atrial and ventricular tachycardias and other arrhythmias resistant to drug therapy. The X Series may be used for cardiac pacing in conscious or unconscious patients for up to a few hours duration as an alternative to endocardial stimulation. The X Series may be used for the monitoring a patients electrocardiogram (ECG).
FDA Enforcement
Class II
·Terminated·ZOLL Medical Corporation·September 26, 2012
MINI INFANT < 3KG, RADIOTRANSLUCENT ELECTRODE, Universal/Anderson Connector, REF/Catalog Number 2602 Indicated for use in external pacing, defibrillation and monitoring applications as a non-sterile, disposable device for single pediatric use, only. The PadPro 2602 electrodes provide the conductive interface between the defibrillator and/or the external transcutaneous (non-invasive) cardiac pacemaker and the pediatric patients skin. The electrode is intended for use on pediatric infants whose weight is less than 10 kg. (22 lbs.).
FDA Enforcement
Class II
·Terminated·ConMed Corporation·April 4, 2018
Persona Stemmed Tibial Provisional Size H Left, Item Number 42532108301 For use during orthopaedic surgery for implantation of a prosthesis.
FDA Enforcement
Class II
·Terminated·Zimmer Biomet, Inc.·May 23, 2018
Siemens Dimension EXL Integrated Chemistry System in vitro diagnostic devices intended to measure a variety of analytes in human body fluids. All Serial #s of material #s: 10636929, 10636928, 10486890, 10472176, 10639337, and 10639338.
FDA Enforcement
Class II
·Terminated·Siemens Healthcare Diagnostics, Inc.·September 3, 2014
Philips Volcano CORE M2 Vascular System, Part # 400-0100.17, Rx Only. Used for the qualitative and quantitative evaluation of vascular morphology in the coronary arteries and vessels of the peripheral vasculature.
FDA Enforcement
Class II
·Terminated·Volcano Corporation·May 23, 2018
SwishPlus Implant 5.7mmD x 8mmL, SBM 6.5mmD Platform, Part Number 925708
FDA Enforcement
Class II
·Terminated·Implant Direct Sybron Manufacturing LLC·February 19, 2020
Artis Q/Q.zen, Angiographic x-ray system Stand alone system The Artis systems are a family of dedicated angiography systems developed for single and biplane diagnostic imaging and interventional procedures including, but not limited to, pediatric and obese patients. Procedures that can be performed with the Artis zee/ zeego and Q/ Q.zen include cardiac angiography, neuro angiography, general angiography, rotational angiography, operating room angiography, multipurpose angiography and whole body radiographic/fluoroscopic procedures. Artis zee/ zeego and Q/ Q.zen can also support the acquisition of position triggered imaging for spatial data synthesis
FDA Enforcement
Class II
·Terminated·Siemens Medical Solutions USA, Inc·January 18, 2017