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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.
ES1725KFX ESPOCAN SPINAL/EPID. TRAY, Material Number 333196 Connection device used by physicians to provide various anesthetic and fluid administration devices with a single, common access point to a catheter for delivery of anesthetics. The connector is used in conjunction with the catheter for continuous administration of anesthetic fluids.
FDA Enforcement
Class II
·Terminated·B. Braun Medical, Inc.·October 10, 2018
ev3, PowerCross .018 OTW PTA Dilatation Catheter, Sterile EO. The PowerCross .018 OTW PTA Dilatation Catheter is intended to dilate stenoses in the iliac, femoral, ilio-femoral, popliteal, infrapopliteal, and renal arteries, and for the treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae. This device is also indicated for stent post-dilatation in the peripheral vasculature.
FDA Enforcement
Class II
·Terminated·Medtronic Inc·December 28, 2016
VITROS Chemistry Products ALC Slides, 90 slides/pack; catalog number 8046872 VITROS ALC Slides quantitatively measure ethanol (ALC) concentration in serum and plasma using VITROS 250/350/950/5,1 FS and 4600 Chemistry Systems and the VITROS 5600 Integrated System.
FDA Enforcement
Class II
·Terminated·Ortho-Clinical Diagnostics·November 27, 2013
The Plum A+ Infusion Systems are a multipurpose family of devices that provides precise delivery of multiple therapies across the general spectrum of clinical care. The Plum A+ family infusion pumps are self contained, microprocessor based infusion devices. The pumps are available in single channel and in triple channel pumping mechanism types.
FDA Enforcement
Class II
·Terminated·ICU·July 19, 2017
VITROS Immunodiagnostic Products - Prolactin Reagent Pack (10758750000111) 1849793
FDA Enforcement
Class II
·Ongoing·Ortho Clinical Diagnostics Inc·October 10, 2018
Affinity Fusion" Oxygenator with Integrated Arterial Filter, Affinity Fusion cardiotomy/Venous Reservoir, Perfusion Tubing Packs The Affinity Fusion Oxygenator with Integrated Arterial Filter with or without the Cardiotomy/Venous Reservoir with Balance¿1 Biosurface is intended for use in an extracorporeal perfusion circuit to oxygenate blood and remove carbon dioxide from the blood and to cool or warm the blood during routine cardiopulmonary bypass procedures up to 6 hours in duration.
FDA Enforcement
Class II
·Terminated·Medtronic Inc·December 28, 2016
Synthes Titanium Trochanteric Fixation Nail (TFN)-Helical Blade Synthes Titanium Trochanteric Fixation Nail (TFN)-Helical Blade is used to treat stable and unstable fractures of the proximal femur including pertrochanteric fractures, intertrochanteric fractures, basal neck fractures, and combinations thereof. The long TFN is additionally indicated for subtrochanteric fractures, pertrochanteric fractures associated with shaft fractures, pathologic fractures (including prophylactic use) in both trochanteric and diaphyseal regions, long subtrochanteric fractures, proximal or distal non-unions, malunions, and revisions.
FDA Enforcement
Class II
·Terminated·Synthes USA HQ, Inc.·November 27, 2013
Affixus Hip Fracture Nail Left 130 Deg 11x300mm, Item Number 814611300 The Affixus Hip Fracture Nail System, comprised of short and long nails, provides surgeons with an intramedullary hip screw to stabilize fractures of the proximal femur.
FDA Enforcement
Class II
·Terminated·Zimmer Biomet, Inc.·November 21, 2018
Bausch + Lomb Stellaris Elite 25 GA Vit Cutter, Model BL5628, 7500 cpm, packaged in sterile pouches, 6/shipper.
FDA Enforcement
Class II
·Terminated·Bausch & Lomb Inc·October 3, 2018
CE18HKPS CONTIN. EPIDURAL TRAY, Material Number 332231 Connection device used by physicians to provide various anesthetic and fluid administration devices with a single, common access point to a catheter for delivery of anesthetics. The connector is used in conjunction with the catheter for continuous administration of anesthetic fluids.
FDA Enforcement
Class II
·Terminated·B. Braun Medical, Inc.·October 10, 2018