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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.

Artis oneFloor-mounted system for uncompromised imaging; Artis one, Interventional fluoroscopic x-ray system, Artis one is an angiography system developed for diagnostic imaging and interventional procedures including, but not limited to, pediatric and obese patients. X-ray generator POLYDOROS A100 Plus

FDA Enforcement
Class II ·Terminated·Siemens Medical Solutions USA, INC·February 21, 2018

Siemens syngo.plaza. Radiological image processing system

FDA Enforcement
Class II ·Terminated·Siemens Medical Solutions USA, Inc·August 1, 2012

LifeVent EVO Ventilator, 02 - Model Number: SP2100X26B Trilogy Evo is intended for pediatric through adult patients weighing at least 2.5 kg. The ventilator can measure, display, record, and alarm SpO2, FiO2, CO2, and Pulse Rate data when integrated with the appropriate accessories.

FDA Enforcement
Class I ·Terminated·Philips Respironics, Inc.·February 26, 2020

Dimension Vista Enzymatic Creatinine (ECREA) reagent, SMN 10700444

FDA Enforcement
Class II ·Terminated·Siemens Healthcare Diagnostics, Inc.·February 26, 2020

Regard, Item Number: 800091003, Sterile, LD0692C - C Section - FMOL Lady of Angels

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

Affixus Hip Fracture Nail, LH 130 DEG 11MM X 300MM

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

Darco STERILE HEADED DRILL BIT 4.4MM , Part Number 777S06514

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

Regard, Item Number: 800599003, Sterile, GS0694C - Robotic Lap - Christus Highland

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

Vado Bi-Directional Steerable Sheath 8.8F, REF SS8FMB74, packaged in a lidded tray that is within a pouch which is inserted into a shelf carton, Sterile, Rx. The firm name on the label is Kalila Medical, Campbell, CA.

FDA Enforcement
Class II ·Terminated·Kalila Medical·February 21, 2018

Regard, Item Number: 800553003, Sterile, OR0642C - Total Knee - Medical Center Santa Rosa

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