42 results
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9ms
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Sources: EU EUDAMED, US FDA
CDI¿ H/S Cuvette The intended use for the CDI¿ H IS Cuvette is as follows: The CDI¿ H/S Cuvettes are intended for use with a CDI monitor during cardiopulmonary bypass procedures when continuous monitoring of blood hematocrit and oxygen saturation is desired.
FDA Enforcement
Class III
·Terminated·Terumo Cardiovascular Systems Corporation·October 12, 2016
The Brilliance CT 16 System Product Usage: The Brilliance 16 is a Whole Body Computed Tomography X-ray System intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data from the same axial plane taken at different angles.
FDA Enforcement
Class III
·Terminated·Philips Medical Systems (Cleveland) Inc·September 26, 2012
6 Panel Cup Body and Lid w/Adult (AU), Item No. TDDA-6MBAU-CUP
FDA Enforcement
Class III
·Terminated·Ameditech Inc·December 30, 2015
Dimension¿ Integrated Chemistry Systems intended to measure a variety of analytes in human body fluids.
FDA Enforcement
Class III
·Terminated·Siemens Healthcare Diagnostics, Inc.·August 6, 2014
Medivance ArcticGel Neonatal Pad The pad is designed to fit into an incubator and provide whole body cooling for patients.
FDA Enforcement
Class III
·Terminated·C.R. Bard, Inc.·August 17, 2016
Siemens Dimension(R) EXL(TM) LM (Siemens Material Number 10486890). Intended to measure a variety of analytes in human body fluids.
FDA Enforcement
Class III
·Terminated·Siemens Healthcare Diagnostics, Inc.·April 10, 2013
Siemens Dimension(R) EXL(TM) 200 (Siemens Material Number 10636929). Intended to measure a variety of analytes in human body fluids.
FDA Enforcement
Class III
·Terminated·Siemens Healthcare Diagnostics, Inc.·April 10, 2013
Siemens Dimension(R) EXL(TM) LM STM (Siemens Material Number 106393377). Intended to measure a variety of analytes in human body fluids.
FDA Enforcement
Class III
·Terminated·Siemens Healthcare Diagnostics, Inc.·April 10, 2013
MICRO-TEMP LT System, Model 749- Localized Heat Therapy System is intended to warm a patient's body part through conductive heat transfer.
FDA Enforcement
Class III
·Terminated·Cincinnati Sub-Zero Products LLC, a Gentherm Company·August 28, 2019
Silicone Fluted Round Drain 24Fr (hubless) & Connector, Sterile. Catalog Number JP-2234. Used for the drainage of body fluids for surgical use.
FDA Enforcement
Class III
·Terminated·Degania Silicone, Ltd.·March 14, 2018
Ultradent Products, Chromaclone PVS, Regular Set heavy body, Bubble Gum Flavor, 50 ml, Impression Material, Part No. 5012, Lot No. B7PPC. Used in prosthodontics.
FDA Enforcement
Class III
·Terminated·Ultradent Products, Inc.·February 20, 2013
Ultradent Products, Chromaclone PVS, Fast Set heavy body, Bubble Gum Flavor, 50 ml, Impression Material, Part No. 5013, Lot No. B7DS3, Used in prosthodontics.
FDA Enforcement
Class III
·Terminated·Ultradent Products, Inc.·February 20, 2013
Access 2 Immunoassay System, Catalog Number 81600N. In vitro diagnostic device used for the quantitative, semi-quantitative, or qualitative determination of various analyte concentrations found in human body fluids.
FDA Enforcement
Class III
·Terminated·Beckman Coulter Inc.·January 10, 2018
Access 2 Immunoassay System, Remanufactured, Catalog Number 386220. In vitro diagnostic device used for the quantitative, semi-quantitative, or qualitative determination of various analyte concentrations found in human body fluids.
FDA Enforcement
Class III
·Terminated·Beckman Coulter Inc.·January 10, 2018
S-O303000 CONTROL, STAT-SITE B-HB, 2X3ML,1LOW,1HIGH - Product Usage: intended for the quantitative determination of the ketone body ¿-Hydroxybutyrate in serum or plasma. For laboratory use only.
FDA Enforcement
Class III
·Terminated·Medline Industries Inc·March 3, 2021
UniCel DxC 600i SYNCHRON Access Clinical Systems; A25656, A25638. In vitro diagnostic device used for the quantitative, semi-quantitative, or qualitative determination of various analyte concentrations found in human body fluids.
FDA Enforcement
Class III
·Terminated·Beckman Coulter Inc.·January 10, 2018
TAUT, Cholangiogram Catheter Intraducer, Peritoneal Catheter, Teleflex Medical, Research Triangle Park, NC. An introduction/drainage catheter accessory is intended to aid in the manipulation of or insertion of the device into the body.
FDA Enforcement
Class III
·Terminated·Teleflex Medical·August 22, 2012
ULTRA Fabric Reinforced Surgical Gown, X-Large, Sterile, Test File. The Kimberly-Clark ULTRA Fabric Reinforced Surgical Gown is a sterile, single use surgical gown intended to protect surgical patients and operating room personnel from the transfer of microorganisms, body fluids, and particulate material.
FDA Enforcement
Class III
·Terminated·Kimberly-Clark Corporation·September 26, 2012
VersaTREK Windows Software, Version 5.4.3 is a component of the VersaTrek System. The Software CD will be individually packaged using a standard CD plastic case and placed into a standard CD mailer The VersaTREK System is for cultivating and recovering microorganisms, especially bacteria and yeasts, from blood and other normally sterile body fluids.
FDA Enforcement
Class III
·Terminated·Trek Diagnostic Systems·September 12, 2012
Medtronic Custom Perfusion Tubing Pack, Rx, Sterile EO. Terumo Cardiovascular Systems (Terumo CVS) has distributed an Urgent Safety Alert regarding the CD I¿ H/S Cuvette. The cuvette is packaged into Medtronic Perfusion Tubing Packs and only sold as part of the pack. This product is indicated for use in the extracorporeal circuit during cardiopulmonary bypass procedures
FDA Enforcement
Class III
·Terminated·Medtronic Perfusion Systems·March 9, 2016