13 results
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7ms
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Sources: EU EUDAMED, US FDA
PHADIA Varelisa Cardiolipin IgM Cardiolipin autoantibody immunological test system (IgM class antibodies)
FDA Enforcement
Class III
·Terminated·Phadia US Inc·September 5, 2012
17-OH Progesterone ELISA 96 well kit- An enzyme immunoassay for the quantitative in vitro diagnostic measurement of 17-OH Progesterone (17-OHP) in serum or plasma Model/Catalog Number: EIA-1292
FDA Enforcement
Class III
·Ongoing·DRG International, Inc.·November 6, 2024
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
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
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
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
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
Sorin Centrifugal Pump System, CP5, Drive Unit (Catalogue Item #60-01-04, UDI: 04033817900948) used in an HLM S5/C5 System configuration. A cardiopulmonary bypass speed control device.
FDA Enforcement
Class III
·Terminated·LivaNova Deutschland GmbH·March 23, 2022
Heraeus, PALAMIX duo. Material Number: 66057897.
FDA Enforcement
Class III
·Ongoing·Heraeus Medical GmbH (Dental Division)·May 6, 2026
Heraeus, PALAMIX uno. Material Number: 66057893.
FDA Enforcement
Class III
·Ongoing·Heraeus Medical GmbH (Dental Division)·May 6, 2026
Laparoscopy Instruments Instructions For Use (IFU) for the following: 1)Monopolar electrode, 2) Insert, handle and/or shaft component of a modular forceps or scissors for electrosurgical coagulation, 3) One-piece forceps or scissors for electrosurgical coagulation
FDA Enforcement
Class III
·Terminated·Dannoritzer Medizintechnik GmbH & Co. KG·October 10, 2018