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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.
Dimension Vista Systems LOCI Thyroid Stimulating Hormone; the TSH method is an in vitro diagnostic test for the quantitative measurement of Thyroid Stimulating Hormone in human serum and plasma on the Dimension Vista System.
FDA Enforcement
Class II
·Terminated·Siemens Healthcare Diagnostics, Inc.·June 10, 2015
FMsealer Open Shears. Model FM3001
FDA Enforcement
Class II
·Terminated·Domain Surgical, Inc.·December 7, 2016
Regard, Item Number: 880326001, Sterile, GS0757A - Major Basin - OSU
FDA Enforcement
Class II
·Terminated·Resource Optimization & Innovation Llc·April 5, 2017
Norian Drillable Inject
FDA Enforcement
Class II
·Terminated·Synthes USA·February 21, 2018
CMI (Collagen Meniscus Implant) device, Ivy Sports Medicine s collagen-based meniscus implant Product Usage: The CMI device, Ivy Sports Medicine s collagen-based meniscus implant, is comprised primarily of bovine type I collagen (nominally 99%) derived from tendon and small quantities of glycosaminoglycans (GAGs: chondroitin sulfate and sodium hyaluronate). The device functions as a resorbable scaffold that is replaced by the patient s own tissue.The CMI device is designed to function as an absorbable template to facilitate host meniscus tissue regeneration in patients who have an irreparable meniscus tear or loss of meniscus tissue. The CMI meniscus tissue through the implant s absorption and replacement by patient s native tissue.
FDA Enforcement
Class II
·Ongoing·Stryker Corporation·March 21, 2018
Regard, Item Number: 800551002, Sterile, GS0640B - Lap Chole - Medical Center Santa Rosa
FDA Enforcement
Class II
·Terminated·Resource Optimization & Innovation Llc·April 5, 2017
BBL Campylobacter CSM Agar (Charcoal-Based Selective Medium), Catalog # 299614, packaged in cartons of 20 plates, and labeled in part ***Becton, Dickinson and Company 7 Loveton Circle Sparks, MD 21152 USA 800-638-8663 www.bd.com/ds*** BCYE Selective with PAV is used in qualitative procedures for isolation of Legionella species from clinical specimen and nonclinical (environmental) samples. It is similar to the Edelstein formula, except that the concentration of polymyxin B is reduced by half, and vancomycin is substituted for cefamandole.
FDA Enforcement
Class II
·Terminated·Becton Dickinson & Co.·July 31, 2013
Medacta International SA, M.U.S.T. Rod, REF 03.50.433, Size 5.5mm, Length 480mm, Type Straight, Mat Co-Cr-Mo The rods act as a connector between the different pedicle screws to create a stable construct for the stabilization and fusion of the lumbar and thoracic spine. Indications for Use: The M.U.S.T. pedicle screw system is intended for posterior non-cervical pedicle fixation (T1-S2/ilium) or anterolateral fixation (T8-L5). The pedicle screws are connected by 5.5mm Titanium alloy or CoCrMo rods to create a stable construct. The construct is secured using a set screw made of CoCrMo.
FDA Enforcement
Class II
·Terminated·Medacta Usa Inc·January 25, 2017
CR-FLEX POR HATCP FEM C-L CR-FLEX POR HATCP FEM C-R CR-FLEX POR HATCP FEM D-L CR-FLEX POR HATCP FEM D-R CR-FLEX POR HATCP FEM E-L CR-FLEX POR HATCP FEM E-R CR-FLEX POR HATCP FEM F-L CR-FLEX POR HATCP FEM F-R CR-FLEX POR HATCP FEM G-L CR-FLEX POR HATCP FEM G-R This device is indicated for patients with severe knee pain and disability
FDA Enforcement
Class II
·Terminated·Zimmer Biomet, Inc.·March 21, 2018
TFE Coated Curved Newton LLT
FDA Enforcement
Class II
·Terminated·Cook Inc.·March 21, 2018