SEO landing

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.

WRIGHT, Wright Medical Technology, VALOR(R) Nail, Right, Medium, OD: 10mm, L: 200mm, REF415101020

FDA Enforcement
Class II ·Terminated·Wright Medical Technology, Inc.·April 25, 2018

Dimension Vista Gentamicin Flex reagent cartridge, DV GENT, gentamicin enzyme immunoassay. Affected lots are 17135BC, 17150BF, 17159BD, 17178AC, 17269BD, and 17312BB.

FDA Enforcement
Class II ·Terminated·Siemens Healthcare Diagnostics, Inc.·June 20, 2018

A.T.S. 2200TS Tourniquet Systems, Personalized Pressure. Zimmer Surgical, Inc. Dover, OH 44622 Intended to be used by qualified professionals to temporarily occlude blood flow in a patient's extremities during surgical procedures on those extremities.

FDA Enforcement
Class II ·Terminated·Zimmer Surgical Inc·February 21, 2018

ACUVUE OASYS Brand Contact Lenses with HYDRACLEAR PLUS

FDA Enforcement
Class II ·Terminated·Johnson & Johnson Vision Care, Inc.·April 4, 2018

BD MAX DNA MMK (SPC) For Laboratory Use, catalog no. 442829

FDA Enforcement
Class III ·Terminated·Becton Dickinson & Co.·May 9, 2018

Medtronic ANGLED DRILL, REF 6630902, QTY: 1 EA Rx only

FDA Enforcement
Class II ·Terminated·Medtronic Sofamor Danek USA Inc·February 21, 2018

PATELLO-FEMORAL JOINT SYSTEM GENDER SOLUTIONS PATELLO-FEMORAL¿ Osteoarthritis, traumatic arthritis, polyarthritis, and/or severe chondrocalcinosis of the patellofemoral joint.

FDA Enforcement
Class II ·Terminated·Zimmer Biomet, Inc.·March 21, 2018

Xario Diagnostic Ultrasound System SSA-660A Used for routine diagnostic imaging

FDA Enforcement
Class II ·Terminated·Toshiba American Medical Systems Inc·November 6, 2013

Truth Renew Plus

FDA Enforcement
Class II ·Terminated·Accord Media, LLC·March 7, 2018

Echelon, Echelon Oval and Oasis MR imaging device systems; one unit per box. The Echelon, Echelon Oval and Oasis MR systems are imaging devices, and are intended to provide the physician with physiological and clinical information, obtained non-invasively and without the use of ionizing radiation. The MR systems produce transverse, coronal, sagittal, oblique, and curved cross-sectional images that display the internal structure of the head, body, or extremities.

FDA Enforcement
Class II ·Terminated·Hitachi Medical Systems America Inc·June 26, 2013