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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.

DEMO No Needle Corrugated Carton 20 U/D, Part Number 2260-03

FDA Enforcement
Class II ·Terminated·Valeritas, Incorporated·November 6, 2019

MediChoice WarmGel Infant Heel Warmer, Item # 1643069911 MediChoice Liquid Infant Heel Warmer, Item # 1643069912 Single Use and Disposable. Distributed by: Owens & Minor. To provide gentle heat to increase blood flow and enhance infant blood sample collection

FDA Enforcement
Class II ·Terminated·CooperSurgical, Inc.·March 25, 2015

MediPress pneumatic compression system Full Leg (Medium)-Segmental Gradient, Model #6103M-S

FDA Enforcement
Class II ·Terminated·Compass Health Brands (Corporate Office)·May 22, 2019

Transonic Hemodialysis Monitor, Model HD03 -- Product Usage: The Hemodialysis Monitor is intended for use by trained medical personnel to measure delivered blood flow, vascular access recirculation, vascular access blood flow and cardiac output on patients receiving hemodialysis treatment.

FDA Enforcement
Class II ·Terminated·Transonic Systems Inc·March 25, 2015

Arrow PICC powered by Arrow VPS Precision Stylet Product Code:CDC-44052-VPS2 Product Usage: The Arrow Pressure Injectable PICC is indicated for short-term or longterm peripheral access to the central venous system for intravenous therapy, blood sampling, infusion, pressure injection of contrast media and allows for central venous pressure monitoring. The maximum pressure of pressure injector equipment used with the pressure injectable PICC may not exceed 300 psi.

FDA Enforcement
Class II ·Terminated·Arrow International Inc·May 22, 2019

The Enzyme 2 Calibrator is an in vitro diagnostic product for the calibration of Alanine Aminotransferase (ALTI and ALTI) and Aspartate Aminotransferase (AST) methods on the Dimension Vista System. For prescription use only.

FDA Enforcement
Class III ·Terminated·Siemens Healthcare Diagnostics, Inc.·February 22, 2017

TSX-IOI: AQUILION 32/64; System, X-Ray, Tomography, Computed. Designed to produce cross-sectional images of a human body.

FDA Enforcement
Class II ·Terminated·Toshiba American Medical Systems Inc·April 17, 2013

Component- Dianz Capacitor used in PerfectO2 Oxygen Concentrator, packaged one unit per box.

FDA Enforcement
Class II ·Terminated·Invacare Corporation·December 31, 2014

The Enzyme II Calibrator is an in vitro diagnostic product for the Alanine Aminotransferase (ALTI) on the Dimension¿ clinical chemistry system. For prescription use only.

FDA Enforcement
Class III ·Terminated·Siemens Healthcare Diagnostics, Inc.·February 22, 2017

MediPress pneumatic compression system Full Leg (Short)-Segmental Gradient, Model #6103S-S

FDA Enforcement
Class II ·Terminated·Compass Health Brands (Corporate Office)·May 22, 2019