19 results
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29ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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MODIFICATION TO BD FACSCANTO SYSTEM WITH BD FACSCANTO CLINICAL SOFTWARE
FDA 510(k)
FDA Class 1
·Clinical Chemistry
BD FACS 7-COLOR SETUP BEADS 25 TESTS
FDA Adverse Event
Malfunction
·BECTON, DICKINSON AND COMPANY, BD BIOSCIENCES·Product code OYE·June 30, 2020
BD FACS¿ 7-COLOR SETUP BEADS 25 TESTS
FDA Adverse Event
Malfunction
·BECTON, DICKINSON AND COMPANY, BD BIOSCIENCES·Product code OYE·May 8, 2025
BD FACS¿ 7-COLOR SETUP BEADS 25 TESTS
FDA Adverse Event
Malfunction
·BECTON, DICKINSON AND COMPANY, BD BIOSCIENCES·Product code OYE·March 28, 2025
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 Enforcement
Class II
·Terminated·Becton, Dickinson and Company, BD Biosciences·June 17, 2020
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 Enforcement
Class II
·Terminated·Becton, Dickinson and Company, BD Biosciences·June 17, 2020
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
MedGyn Pessary Cerclage w/o drain #1
FDA UDI
MEDGYN PRODUCTS, INC.·M803050191·Pessary Cerclage is used to treat uterine prola...
AXSOS
FDA UDI
Stryker GmbH·07613327093407·Temp. Plate Fixator Pin AO Fitting
Marina Medical
FDA UDI
MARINA MEDICAL INSTRUMENTS, INC.·00840306812842·Metzenbaum Scissors, Straight, 31cm
DC-IN CABLE（MIC）Kit
FDA UDI
Shenzhen Mindray Bio-Medical Electronics Co., Ltd.·06944904098647·
Y2000 POCKET RESCUE
FDA 510(k)
FDA Class 2
·Anesthesiology
TERASON MODEL 2000/BAS PORTABLE ULTRASOUND SYSTEM
FDA 510(k)
FDA Class 2
·Radiology
ISODUR PROSTHESIS HEAD 12/14 28MM M
FDA Adverse Event
Malfunction
·AESCULAP AG AND CO. KG·Product code LPH·January 16, 2015
DEPUY PINNACLE ACETABULAR CUP
FDA Adverse Event
Injury
·DEPUY ORTHOPAEDICS, INC.·Product code KWA·March 15, 2013
NUCLEUS 24 CHANNEL COCHLEAR IMPLANT SYSTEM
FDA Adverse Event
Injury
·COCHLEAR LTD.·Product code MCM·May 23, 2008
SYNCHROMED EL
FDA Adverse Event
Malfunction
·RICE CREEK MANUFACTURING·Product code LKK·April 1, 2011
Instructions For Use document of the GPS Trackers.
FDA Enforcement
Class II
·Terminated·Blue Ortho·November 4, 2020