16 results
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8ms
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Sources: EU EUDAMED, US FDA
Curity I.V. Start Kit, Product ID: 80530 and Curity I.V. Start Kit Product ID: 8508. IV Start Kit.
FDA Enforcement
Class III
·Terminated·Covidien LLC·May 22, 2013
BD PhoenixTM AP, Catalog Number 448010 The BD Phoenix" AP instrument is designed for use with the BD Phoenix" system is intended to standardize ID broth tube inoculum, add AST indicator to the AST broth tube and transfer an aliquot of ID broth to AST broth tubes, as required for preparing samples for use on the BD Phoenix" system, which performs identification and susceptibility testing
FDA Enforcement
Class III
·Terminated·Becton Dickinson & Co.·December 13, 2017
Sepp, Compound Benzoin Tincture Packaged and Tincture 3,000 Bulk. Product Usage: Preoperative skin product
FDA Enforcement
Class III
·Terminated·CareFusion 213, LLC·April 3, 2013
The brand name of the device is Damon 3MX Bicuspid Bracket, an orthodontic bracket. Part Number 494-4491, Description -Damon 3MX Bicuspid Bracket, Lot Number - 011265039 Product Usage: Damon 3MX Bicuspid Brackets are intended to be a fixed attachment on a tooth which holds an archwire during orthodontic treatment.
FDA Enforcement
Class III
·Terminated·Ormco/Sybronendo·October 31, 2012
The Better-Bladder With 14" ID tubing, ITEM BB14, STERILE, Measure pressure noninvasively in the extracorporeal circuit and provide compliance in the venous line between the patient and the pump.
FDA Enforcement
Class III
·Terminated·Circulatory Technology Inc·October 19, 2016
Software Package, iPAW 4.2 User Kit, Part No. B73489, Manufactured by: Beckman Coulter Biomedical GmbH The iPAW 4.2 User Kit (PN B73489) includes the iPAW software application CD (version 4.2). This function is primarily used to copy an existing barcode ID to replace the label of an individual sample tube because the original label is deteriorated.
FDA Enforcement
Class III
·Terminated·Beckman Coulter Inc.·November 7, 2018
BBL CrystaLEAD Enteric/Nonfermentor (E/NF) Identification (ID) System, catalog number 245000. in vitro diagnostic for the identification of aerobic gram-negative bacteria that belong to the family Enterobacteriaceae as well as some of the more frequently isolated glucose fermenting and nonfermenting gram-negative bacilli.
FDA Enforcement
Class III
·Terminated·Becton Dickinson & Co.·July 23, 2014
Sunquest Laboratory SMART & Sunquest Laboratory SMART Select Product Usage: for clinical use
FDA Enforcement
Class III
·Terminated·Sunquest Information Systems, Inc.·August 29, 2012
Optovue iVue with Normative Database (NDB) with Software Version 3.0 and 3.1. Intended for in vivo imaging.
FDA Enforcement
Class III
·Terminated·Optovue, Inc.·June 12, 2013
Software Package, iPAW 4.2.1 User Kit for Windows XP and Windows 10, Part No. B95343, Manufactured by: Beckman Coulter Biomedical GmbH Sorting-Drive software version 4.2 (released in October 2015) introduced a new option for iPAW and the Sorting-Drive Client that is used for manual printing of barcodes.
FDA Enforcement
Class III
·Terminated·Beckman Coulter Inc.·November 7, 2018
Intelligent Peri-Analytical Workstation (HW+SW), Catalog #: A89492 (iPAW Software v4.2.1), Beckman Coulter, Inc. The iPAW ((intelligent Peri-Analytical Workstation) can act as: a software client for specimen tracking and workload statistics or a physical workstation for manual sorting and label printing.
FDA Enforcement
Class III
·Terminated·Beckman Coulter Inc.·November 7, 2018
Sorting-Drive Product Part, Sorting-Drive Plus Kit (Sorting Drive Software v4.2.1), Part No. A89483, Beckman Coulter, Inc. The Sorting-Drive Plus Kit includes the Sorting-Drive 4.2.1 User Kit which includes the Sorting-Drive 4.2.1 Software DVD. . The Sorting-Drive software facilitates the Laboratory Information System (LIS) connection to AutoMate 2500 Family systems. .
FDA Enforcement
Class III
·Terminated·Beckman Coulter Inc.·November 7, 2018
Software Package, Sorting-Drive 4.2 User Kit, Part No. B73488, Manufactured by: Beckman Coulter Biomedical GmbH The Sorting-Drive itself is an optional software to be used with the Automate 2500 Family of products. The system automates the process of sorting, decapping, and archiving samples. The Sorting-Drive 4.2. User Kit includes the Sorting-Drive Client software application that includes an option for manual printing of barcodes for sample tubes.
FDA Enforcement
Class III
·Terminated·Beckman Coulter Inc.·November 7, 2018
Sorting-Drive Professional Part, Sorting-Drive Professional Kit, (Sorting Drive Software v4.2.1), Part No. A94144, Beckman Coulter, Inc. The Sorting-Drive Professional Kit (PN A94144) includes the Sorting-Drive 4.2.1 User Kit (PN B95347) which includes the Sorting-Drive 4.2.1 Software DVD (PN B95346). This software version includes an option for manual barcode printing for sample tubes. Sorting-Drive software facilitates the Laboratory Information System (LIS) connection to AutoMate 2500 Family systems.
FDA Enforcement
Class III
·Terminated·Beckman Coulter Inc.·November 7, 2018
BD FACS Universal Loader (Optional) to the BD FACSLyric Clinical System, Model 662879 (Universal Loader), Rx Only. The firm name on the label is Becton, Dickinson and Company, BD Biosciences, San Jose, CA. The Loader offers various settings to resuspend and mix samples. It can draw from 12 x 75-mm tubes in 30- and 40-tube racks. A barcode reader verifies the ID on tube racks and individual tubes in 30- tube racks. A built-in imaging system provides safety checks, such as verifying the correct rack type and tube layout, and ensures the tubes were loaded correctly.
FDA Enforcement
Class III
·Terminated·Becton, Dickinson and Company, BD Biosciences·August 8, 2018
Software Package, Sorting-Drive 4.2.1 User Kit for Windows XP and Windows 10, Part No. B95347, Manufactured by: Beckman Coulter Biomedical GmbH The Sorting-Drive itself is an optional software to be used with the Automate 2500 Family of products. . The Sorting-Drive 4.2.1 User Kit includes the Sorting-Drive Client software application that includes an option for manual printing of barcodes for sample tubes; version 4.2 was replaced by version 4.2.1 (they both contain the same option for manual barcode printing). This function is primarily used to copy an existing barcode ID to replace the label of an individual sample tube because the original label is deteriorated.
FDA Enforcement
Class III
·Terminated·Beckman Coulter Inc.·November 7, 2018