16 results
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Sources: EU EUDAMED, US FDA
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CD DIAGNOSTICS, INC
FDA registration
CD DIAGNOSTICS, INC·3 products·🇺🇸 United States
Synovasure® Alpha Defensin
FDA UDI
CD DIAGNOSTICS, INC.·00887868540691·
Synovasure® Alpha Defensin
FDA UDI
CD DIAGNOSTICS, INC.·00887868358814·
Synovasure® Alpha Defensin
FDA UDI
CD DIAGNOSTICS, INC.·00887868540660·
Synovasure® Alpha Defensin
FDA UDI
CD DIAGNOSTICS, INC.·00887868358852·
Synovasure®
FDA UDI
CD DIAGNOSTICS, INC.·00887868358845·
Synovasure® Alpha Defensin
FDA UDI
CD DIAGNOSTICS, INC.·00887868358821·
Synovasure® Alpha Defensin
FDA UDI
CD DIAGNOSTICS, INC.·00887868540677·
Synovasure® Alpha Defensin
FDA UDI
CD DIAGNOSTICS, INC.·00887868540653·
Synovasure® Alpha Defensin
FDA UDI
CD DIAGNOSTICS, INC.·00887868540684·
Synovasure®
FDA UDI
CD DIAGNOSTICS, INC.·00887868358838·
BreathTek Urea Hydrolysis Rate Calculation CD, Version 1.3.5 - January 1,'03, in vitro diagnostic. Meretek Diagnostics, Inc., Lafayette, CO.
FDA Recall
Terminated
·Meretek Diagnostics, Inc.·Product code MSQ·May 2, 2007
OPD-Scan III Refractive Power/Corneal Analyzer Opthalmic Software versions 1.00.08 1.05.07 1.10.01, 1.01.02 1.06.02 1.11.02, 1.02.01 1.07.01 1.12.03, 1.03.02 1.08.01 1.13.01, 1.04.03 1.09.01. Opthalmic: The OPD-Scan III is a diagnostic instrument that is indicated for use for Mapping of refractive error distribution of the eye by measurement and analysis of spherical power, cylindrical power, and cylinder axis.
FDA Recall
Terminated
·Nidek Inc·Product code HKO·June 15, 2015
Retcam3 & Retcam Shuttle with version 6.0 software. Clarity Medical Systems, Inc. 5775 W. Las Positas Blvd, Suite 200 Pleasanton, CA 94588 General ophthalmic imaging including retinal, corneal and external imaging. Photodocumentation of pediatric ocular diseases including retinopathy or prematurity (ROP). Screening of Type-2 re-threshold retinopathy of prematurity or treatment requiring ROP.
FDA Recall
Terminated
·Clarity Medical Systems Inc·Product code HKI·February 2, 2012
INRatio Monitors - 0100004 Alere INRatio PT/INR System Professional - 0100007 INRatio Prothrombin Time (PT) Monitoring System - 0100137 Alere INRatio Replacement Monitor The test systems contain individually packaged components needed to use the product, such as a monitor, user guide, quick reference guide training DVD or CD, Lancets (home monitoring kits contain an Autolet, Unilet, gauze pads, and alcohol wipes), power supply (home monitoring kits contain AA batteries), results log book and a warranty card. None of the components, except for the lancets, are sterile. In vitro diagnostic monitoring system used for the quantitative measurement of Prothrombin Time (PT) in fresh, capillary whole blood.
FDA Recall
Terminated
·Alere San Diego, Inc.·Product code GJS·December 5, 2014
INRatio 2 Monitors - 0200431 Alere INRatio 2 PT/INR Professional Testing System - 0200432 Alere INRatio 2 PT/INR Home Monitoring System - 0200433 Alere INRatio 2 PT/INR Home Monitoring System - 0200457 Alere INRatio 2 Replacement Monitor - 55112 Alere INRatio 2 Replacement Monitor - 55131 Alere INRatio 2 Replacement Monitor - 55128A Alere INRatio 2 PT/INR Professional Monitoring System The test systems contain individually packaged components needed to use the product, such as a monitor, user guide, quick reference guide training DVD or CD, Lancets (home monitoring kits contain an Autolet, Unilet, gauze pads, and alcohol wipes), power supply (home monitoring kits contain AA batteries), results log book and a warranty card. None of the components, except for the lancets, are sterile. Intended for in vitro diagnostic use for quantitative determination of international normalized ratio (INR) in fresh capillary whole blood to monitor the effect of warfarin on clotting time by health care professionals and home users.
FDA Recall
Terminated
·Alere San Diego, Inc.·Product code GJS·December 5, 2014