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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.
Palindrome Precision HSI Chronic Catheter Sport Pack w/VenaTrac Stylet 14.5 Fr x 23cm Item Code: 8888123409P
FDA Enforcement
Class II
·Terminated·Covidien LLC·July 8, 2015
Edwards Lifesciences Swan-Ganz Thermodilution VIP Catheters Model 131F7J. For use in patients who require hemodynamic monitoring.
FDA Enforcement
Class II
·Terminated·Edwards Lifesciences, LLC·August 22, 2012
Military Kit Portable Clinical Analyzer ; Abbott Point of Care, Princeton, NJ 08540 Model 200. The 37 degree tests for sodium, potassium, ionized calcium, hematocrit, pH, PCO2, PO2, and the i-Stat 200 analyzer as port of the i-Stat System, are intended for use in the in vitro quantitization of arterial, venous, or capillary whole blood 510 K940918 Model 300. The i-Stat Model 300 Portable Clinical Analyzer is intended to be used by trained medical professional for use with i-Stat test cartridges and MediSense blood glucose test strips. i-State cartridges comprise a variety of clinical chemistry tests and test panels. 510K 001387
FDA Enforcement
Class II
·Terminated·Abbott Point Of Care Inc.·July 18, 2012
Regard, Item Number: 800524002, Sterile, LD0608B - C Section - Westover Hills
FDA Enforcement
Class II
·Terminated·Resource Optimization & Innovation Llc·April 5, 2017
TAUT, Cholangiogram Catheter Intraducer, Peritoneal Catheter, Teleflex Medical, Research Triangle Park, NC. An introduction/drainage catheter accessory is intended to aid in the manipulation of or insertion of the device into the body.
FDA Enforcement
Class III
·Terminated·Teleflex Medical·August 22, 2012
Persona, The Personalized Knee System, Tibial Sizing Plate, Cemented, Nonsterile, Size H Left; Size H Right This device is used with the Persona Knee System for patients with severe knee pain and disability due to: Rheumatoid arthritis, osteoarthritis, traumatic arthritis, polyarthritis. o Collagen disorders, and/or avascular necrosis of the femoral condyle. o Post-traumatic loss of joint configuration, particularly when there is patellofemoral erosion, dysfunction or prior patellectomy. o Moderate valgus, varus, or flexion deformities
FDA Enforcement
Class II
·Terminated·Zimmer, Inc.·December 26, 2012
Regard, Item Number: 800554003, Sterile, GS0643C - Pediatric Basic - Childrens Santa Rosa
FDA Enforcement
Class II
·Terminated·Resource Optimization & Innovation Llc·April 5, 2017
Palindrome Precision HSI Chronic Catheter Kit w/VenaTrac Stylet 14.5 Fr x 28cm Item Code: 8888145049P
FDA Enforcement
Class II
·Terminated·Covidien LLC·July 8, 2015
SOL SYS L 9IN CALC 2.25/16.5 Packaging: Product is packed within a poly protector, with protection added as needed for fragile points. The entire stem is then placed within a foam sleeve for added protection. The assembly is then placed and sealed in an inner and outer tray for aseptic transfer. The sealed package is placed into a folding carton, labeled, and shrink wrapped. Intended Use: SOLUTION System Calcar Stems are used in total hip arthroplasty (THA) to provide increased patient mobility and reduce pain by replacing the damaged hip joint articulation in patients where there is evidence of sufficient sound bone to seat and support the components.
FDA Enforcement
Class II
·Terminated·DePuy Orthopaedics, Inc.·December 26, 2012
GE Healthcare Innova IGS 630. Angiographic X-ray systems used in generating fluoroscopic and rotational images of human anatomy for diagnostic, interventional and image-guided surgical procedures.
FDA Enforcement
Class II
·Terminated·GE Healthcare·July 8, 2015