15 results
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19ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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DIAGNOSTIC REAGENT TST-RPLA
FDA 510(k)
FDA Class 1
·Microbiology
Wrap Around Hawley Retainer
FDA UDI
AMERICAN ORTHODONTICS CORPORATION·00190746074349·RETAINER WRAP AROUND HAWLEY MEDIUM 032 MP35 WIR...
LINK Endo-Model EVO Knee System
FDA UDI
WALDEMAR LINK GmbH & Co. KG·04026575182893·Femoral component, cemented, CoCrMo, UHMWPE, Ti...
BME AMINO ACIDS 100X
FDA 510(k)
FDA Class 1
·Hematology
HAEMODIALYSIS SETS & DIALIFLEX FISTULA NEEDLES
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
OT VERIO IQ METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·June 9, 2014
ASKU
FDA Adverse Event
Malfunction
·MEDTRONIC, INC.·Product code DTB·October 6, 2010
POWERED WHEELCHAIR
FDA Adverse Event
Malfunction
·INVACARE TAYLOR STREET·Product code ITI·December 3, 2012
Anti-Lambda APC-H7, Catalog Number 656157. Product Usage: Intended for in vitro flow cytometric immunophenotyping of hematologic disorders.
FDA Recall
Terminated
·BD Biosciences, Systems & Reagents·Product code MVU·December 19, 2014
CD79b PE (ASR) , Catalog number 335816 ; Hematology: The CD79b antibody recognizes an epitope on the extracellular domain of a 3640 kilodalton (kDa) type I membrane glycoprotein. Immunoglobulin (Ig) antigen receptors are composed of a non-covalently associated complex of Ig and two other proteins, Iga and Igb, which have been designated as CD79a and CD79b, respectively. antigen
FDA Recall
Terminated
·Becton, Dickinson and Company, BD Biosciences·Product code MVU·September 21, 2016
BD Tritest CD3 FITC/CD4 PE/CD45 PerCP (IVD); Catalog number 340383. Label states: Contains CD3 FITC/CD4 PE/CD45 per CP with Gelatin and 0.1% sodium azide. Hematology: BD Tritest CD3 fluorescein isothiocyanate (FITC)/CD4 phycoerythrin (PE)/CD45 peridinin chlorophyll protein (PerCP) is a three-color direct immunofluorescence reagent for use with a suitably equipped flow cytometer to identify and determine the percentages and absolute counts of mature human T lymphocytes (CD3+) and helper/inducer (CD3+CD4+) Tlymphocyte subsets in erythrocyte-lysed whole blood.
FDA Recall
Terminated
·Becton, Dickinson and Company, BD Biosciences·Product code GKZ·July 18, 2016
BD FACS 7-color Setup beads BD Biosciences, San Jose, CA 95131. BD FACS 7 color Setup Beads are for in vitro diagnostic use on BD FACSCanto or BD FACSCanto II systems. The beads are run with BD FACSCanto clinical software. This system provides application specific setup, including automated compensation and cytometer quality control (QC) with minimal user intervention.
FDA Recall
Terminated
·BD Biosciences, Systems & Reagents·Product code GKZ·June 29, 2012
BD FACS Sample Prep Assistant (SPA) III - Product Usage: Prep Assistant III is intended to prepare human whole blood for flow cytometric analysis on BD FACSCanto II and BD FACSCalibur flow cytometry systems. Pipetting blood, reagents, and lysing solution using the following previously cleared assays for flow cytometric analysis on BD FACSCanto II flow cytometry systems
FDA Recall
Terminated
·Becton, Dickinson and Company, BD Biosciences·Product code PER·July 8, 2019
BD FACS Sample Prep Assistant (SPA) II - Product Usage: K050191: The BD FACSCanto system with BD FACSCanto clinical software when used with the BD FACS Sample Prep Assistant II /III is intended for use as an in vitro diagnostic device for identification and enumeration of lymphocyte subsets in human cells in suspension using a lyse / no-wash sample preparation method for flow cytometry.
FDA Recall
Terminated
·Becton, Dickinson and Company, BD Biosciences·Product code PER·July 8, 2019
BD FACS Sample Prep Assistant (SPA) II Upgrade - Product Usage: K050191: The BD FACSCanto system with BD FACSCanto clinical software when used with the BD FACS Sample Prep Assistant II /III is intended for use as an in vitro diagnostic device for identification and enumeration of lymphocyte subsets in human cells in suspension using a lyse / no-wash sample preparation method for flow cytometry.
FDA Recall
Terminated
·Becton, Dickinson and Company, BD Biosciences·Product code PER·July 8, 2019