13 results
·
27ms
·
Sources: EU EUDAMED, US FDA
THE ODFS DROPPED FOOT STIMULATOR
FDA 510(k)
FDA Class 2
·Neurology
SEEDNET, MODELS FP6T5, FP5T5, FP5T3
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
MODIFICATION TO TSRH SPINAL SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
PROTECTA XT CRT-D
FDA Adverse Event
Injury
·IPG MFG SWITZERLAND·Product code NIK·April 10, 2013
ARCHITECT HAVAB IGM REAGENT
FDA Adverse Event
Malfunction
·ABBOTT·Product code LOL·April 12, 2011
ATLAS II HF CRT-D
FDA Adverse Event
Injury
·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code NIK·May 27, 2008
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