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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.
XP-CR Tibial Tray - Interlok 73mm Item # 195274
FDA Enforcement
Class II
·Terminated·Zimmer Biomet, Inc.·September 18, 2019
DiaSorin, PRO-Trac II Tacrolimus ELISA kit, REF 32400 and 32400-CN. Product Usage: The PRO-Trac II Tacrolimus ELISA kit is an in vitro reagent system intended for the quantitative determination of tacrolimus (Prografl, FK506) and some metabolites in human EDT A or heparinized whole blood as an aid in the management of liver transplant patients receiving tacrolimus therapy.
FDA Enforcement
Class II
·Terminated·Diasorin Inc.·April 29, 2015
Natrelle Saline-Filled Breast Implant, for the following Styles and sizes, Style LP, Style 68 HP, Style 68 MP, Style LP/UDI: NATRELLE Style 68LP-125 Saline Round Low 10888628000513, NATRELLE Style 68LP-150 Saline Round Low 10888628000520, NATRELLE Style 68LP-175 Saline Round Low 10888628000537, NATRELLE Style 68LP-200 Saline Round Low 10888628000544, NATRELLE Style 68LP-225 Saline Round Low 10888628000551, NATRELLE Style 68LP-250 Saline Round Low 10888628000568, NATRELLE Style 68LP-275 Saline Round Low 10888628000575, NATRELLE Style 68LP-300 Saline Round Low 10888628000582, NATRELLE Style 68LP-325 Saline Round Low 10888628000599, NATRELLE Style 68LP-350 Saline Round Low 10888628000605, NATRELLE Style 68LP-400 Saline Round Low 10888628000612, NATRELLE Style 68LP-420 Saline Round Low 10888628000629, NATRELLE Style 68LP-440 Saline Round Low 10888628000636, NATRELLE Style 68LP-480 Saline Round Low 10888628000643, NATRELLE Style 68LP-525 Saline Round Low 10888628000650, NATRELLE Style 68LP-550 Saline Round Low 10888628000667, NATRELLE Style 68LP-600 Saline Round Low 10888628000674, NATRELLE Style 68LP-640 Saline Round Low 10888628000681, NATRELLE Style 68LP-680 Saline Round Low 10888628000698, Style 68 HP/UDI: NATRELLE Style 68HP-160 Saline Round High 10888628000353, NATRELLE Style 68HP-200 Saline Round High 10888628000360, NATRELLE Style 68HP-240 Saline Round High 10888628000377, NATRELLE Style 68HP-280 Saline Round High 10888628000384, NATRELLE Style 68HP-320 Saline Round High 10888628000391, NATRELLE Style 68HP-350 Saline Round High 10888628000407, NATRELLE Style 68HP-400 Saline Round High 10888628000414, NATRELLE Style 68HP-425 Saline Round High 10888628000421, NATRELLE Style 68HP-465 Saline Round High 10888628000438, NATRELLE Style 68HP-500 Saline Round High 10888628000445, NATRELLE Style 68HP-550 Saline Round High 10888628000452, NATRELLE Style 68HP-600 Saline Round High 10888628000469, NATRELLE Style 68HP-650 Saline Round High 10888628000476, NATRELLE Style 68HP-700 Saline Round High 10888628000483, NATRELLE Style 68HP-750 Saline Round High 10888628000490, NATRELLE Style 68HP-800 Saline Round High 10888628000506, Style 68 MP/UDI: NATRELLE Style 68MP-120 Saline Round Mod 10888628000155, NATRELLE Style 68MP-150 Saline Round Mod 10888628000162, NATRELLE Style 68MP-180 Saline Round Mod 10888628000179, NATRELLE Style 68MP-210 Saline Round Mod 10888628000186, NATRELLE Style 68MP-240 Saline Round Mod 10888628000193, NATRELLE Style 68MP-270 Saline Round Mod 10888628000209, NATRELLE Style 68MP-300 Saline Round Mod 10888628000216, NATRELLE Style 68MP-330 Saline Round Mod 10888628000223, NATRELLE Style 68MP-360 Saline Round Mod 10888628000230, NATRELLE Style 68MP-390 Saline Round Mod 10888628000247, NATRELLE Style 68MP-420 Saline Round Mod 10888628000254, NATRELLE Style 68MP-450 Saline Round Mod 10888628000261, NATRELLE Style 68MP-480 Saline Round Mod 10888628000278, NATRELLE Style 68MP-510 Saline Round Mod 10888628000285, NATRELLE Style 68MP-550 Saline Round Mod 10888628000292, NATRELLE Style 68MP-600 Saline Round Mod 10888628000308, NATRELLE Style 68MP-650 Saline Round Mod 10888628000315, NATRELLE Style 68MP-700 Saline Round Mod 10888628000322, NATRELLE Style 68MP-750 Saline Round Mod 10888628000339, NATRELLE Style 68MP-800 Saline Round Mod 10888628000346,
FDA Enforcement
Class III
·Terminated·Allergan PLC·December 25, 2019
RECLAIM Distal Reamer Extension Non Sterile REF 2975-00-500 Intended as an attachment device to the distal reamers to allow the surgeon to clear soft tissue while reaming the distal femoral canal.
FDA Enforcement
Class II
·Terminated·DePuy Orthopaedics, Inc.·October 15, 2014
McGhan Croissant-Shaped Tissue Expanders, Style 134 Product Usage: intended for temporary subcutaneous implantation and require periodic, incremental inflation with sterile saline for injection until the desired amount of tissue is developed.
FDA Enforcement
Class I
·Ongoing·Allergan PLC·September 18, 2019
Regard, Item Number: 800557001, Sterile, LD0646A - C Section - Childrens Santa Rosa
FDA Enforcement
Class II
·Terminated·Resource Optimization & Innovation Llc·April 5, 2017
OptiMedica Catalys Precision Laser System; Model No(s). Catalys-U (US), and Catalys-I (Outside US). Product Usage: Indicated for use in patients undergoing cataract surgery for removal of crystalline lens.
FDA Enforcement
Class II
·Terminated·Abbott Medical Optics, Inc.·April 29, 2015
Regard, Item Number: 800410003, Sterile, CV0479C - Open Heart PK - Spohn
FDA Enforcement
Class II
·Terminated·Resource Optimization & Innovation Llc·April 5, 2017
BD FACSLyric 3L 10C with FACSuite Clinical Software v1.1.1, catalog number 662878 BD FACSLyric is a high-performance flow cytometer designed to support both routine clinical analysis and research for the identification, quantification, and characterization of cells in support of cell analysis. BD FACSuite software is loaded onto an adjacent PC workstation and is used to operate the instrument, acquire samples, and analyze data. Quality control performance, tracking, and reporting are streamlined and automated. Routine tasks such as daily cleaning and shutdown can be programmed to occur automatically. The BD FACSuite clinical software allows users to run BD IVD assays.
FDA Enforcement
Class III
·Terminated·Becton, Dickinson and Company, BD Biosciences·February 13, 2019
Regard, Item Number: 800524003, Sterile, LD0608C - C Section - Westover Hills
FDA Enforcement
Class II
·Terminated·Resource Optimization & Innovation Llc·April 5, 2017