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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.

Azure S DR MRI, Model Number W3DR01

FDA Enforcement
Class II ·Ongoing·Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)·July 15, 2020

Keo Brace, elastic wrist brace for carpal tunnel. A limb orthosis (brace) is a device intended for medical purposes that is worn on the upper or lower extremities to support, to correct, or to prevent deformities or to align body structures for functional improvement.

FDA Enforcement
Class II ·Terminated·United Surgical Associates·June 3, 2015

Regard, Item Number: 880321002, Sterile, GS0752B - Breast PK - OSU

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

Radial Artery Catheterization Set, 1) NA-04550-1A & 2) NA-04550-X1A, device permits access to the peripheral arterial circulation or to other small vessels.

FDA Enforcement
Class II ·Terminated·Arrow International Inc·February 21, 2018

Graseby 3300 Pump and Graseby 3000 Series Pump Accessories Patient controlled syringe pump. Use for Infusion

FDA Enforcement
Class II ·Terminated·Smiths Medical ASD Inc.·February 7, 2018

SynchroMed II implantable drug infusion pump, Model 8637-40,

FDA Enforcement
Class II ·Terminated·Medtronic Neuromodulation·April 5, 2017

Lamicel 20PK 3MM INTL Cervical dilator

FDA Enforcement
Class II ·Ongoing·Medtronic Xomed, Inc.·January 1, 2020

Affixus Hip Fracture Nail, LH 130 DEG 9MM X 420MM

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

Regard, Item Number: 800036004, Sterile, LD0274D - C Section Pack - FMOL St Francis

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

Philips SureSigns VSi / SureSigns VS2+ vital signs monitor used in healthcare environments and transport within a facility.

FDA Enforcement
Class III ·Terminated·Philips Electronics North America Corporation·December 27, 2017