27 results
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14ms
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Sources: EU EUDAMED, US FDA
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Classification: Class Iii
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OraQuick HCV Visual Reference Panel Intended to assist new operation in becoming proficient at reading specimens with antibody levels near the limit of detection of the device.
FDA Enforcement
Class III
·Terminated·OraSure Technologies, Inc.·April 27, 2016
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
Daavlin Aquex (DAAV1000)
FDA Enforcement
Class III
·Terminated·Hidrex GmbH·March 1, 2017
Hidrex USA DVP1000
FDA Enforcement
Class III
·Terminated·Hidrex GmbH·March 1, 2017
Hidrex USA DP450
FDA Enforcement
Class III
·Terminated·Hidrex GmbH·March 1, 2017
CK MB Calibrator, Catalogue Number CK2393
FDA Enforcement
Class III
·Terminated·Randox Laboratories Ltd.·May 25, 2022
Navitrack¿ System - OS Knee Universal, Orthopedic Stereotaxic Instrument
FDA Enforcement
Class III
·Terminated·Orthosoft, Inc. dba Zimmer CAS·May 24, 2017
ARCHITECT C Peptide Calibrator - Product Usage: used as an aid in the diagnosis and treatment of patients with abnormal insulin secretion including diabetes mellitus.
FDA Enforcement
Class III
·Terminated·Abbott Laboratories·May 13, 2020
ARCHITECT C Peptide Calibrator - Product Usage: used as an aid in the diagnosis and treatment of patients with abnormal insulin secretion including diabetes mellitus.
FDA Enforcement
Class III
·Terminated·Abbott Laboratories·May 13, 2020
ARCHITECT C Peptide Reagent - Product Usage: used as an aid in the diagnosis and treatment of patients with abnormal insulin secretion including diabetes mellitus.
FDA Enforcement
Class III
·Terminated·Abbott Laboratories·May 13, 2020
Pointe Scientific Chemistry Controls Level I and II LEVl: Amber glass vial w/PP white plastic cap. LEV2: Amber glass vial w/PP black plastic cap.
FDA Enforcement
Class III
·Terminated·Medtest Holdings, Inc.·May 31, 2017
Model 731 EMV+ Uni-Vent, Impact Instrumentation Inc., 27 Fairfield Place, West Caldwell NJ 07006. Indicated for use in the management of acute or chronic respiratory failure or during resuscitation by providing continuous positive -pressure ventilation.
FDA Enforcement
Class III
·Terminated·Impact Instrumentation, Inc.·August 15, 2012
Maquet/Getinge Rotaflow System Console US (115 V / 60 Hz) - Product Usage: Instructions for Use - Centrifugal Pump System is a device that uses a method other than revolving rollers to pump the blood through an extracorporeal circuit Material Number: 701043292
FDA Enforcement
Class III
·Terminated·Maquet Cardiovascular Us Sales, Llc·September 23, 2020
Gas Module 3 monitoring spirometer, Part Number: 115-030108-00 Product Usage: The Gas Module 3 is an accessory device designed to monitor airway gases during anesthesia and/or assisted respiration. Monitored gases includes O2, CO2, N2O and anesthetic agents Halothane, Isoflurane, Sevoflurane, Desflurane and Enflurane. It is intended for use in a fixed location such as the operating room or intensive care unit. The Gas Module 3 is compatible with Mindray patient monitors which display the gas analysis results through the use of a proprietary communication protocol.
FDA Enforcement
Class III
·Terminated·Mindray DS USA, Inc. dba Mindray North America·April 4, 2018
DIASTAT(R) ANA (anti-Nuclear antibody) EURO DIAGNOSTICA, The DIASTAT(R) anti-nuclear antibody (ANA) test is a qualitative enzyme-linked immunosorbent assay (ELISA) for the detection of ANAs in human serum or EDTA plasma. It detects ANAs against Sm, Sm/RNP, Ro (SS-A), La (SS-B), Scl-70, Jo-1, dsDNA, histone and centromere antigens.
FDA Enforcement
Class III
·Terminated·Euro Diagnostica AB·July 5, 2017
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
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
ACE Control Set - IVD Control set for the quantitative determination of Angiotensin Converting Enzyme (ACE) REF 1667001
FDA Enforcement
Class III
·Ongoing·Sentinel CH SpA·July 14, 2021
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