17 results
·
18ms
·
Sources: EU EUDAMED, US FDA
THE LOTECON PERSONAL CARE SYSTEM
FDA 510(k)
FDA Class 2
·General Hospital
EVOLUT FX VALVE
FDA Adverse Event
Malfunction
·MEDTRONIC MEXICO S. DE R.L. DE CV·Product code NPT·March 10, 2026
EVOLUT FX VALVE
FDA Adverse Event
Malfunction
·MEDTRONIC MEXICO S. DE R.L. DE CV·Product code NPT·March 10, 2026
Sierra
FDA UDI
Seaspine Orthopedics Corporation·10889981094959·Angled Occipital Guide
GammaBeam 500
FDA 510(k)
FDA Class 2
·Radiology
MODIFICATION TO BD FACSCANTO SYSTEM WITH BD FACSCANTO CLINICAL SOFTWARE
FDA 510(k)
FDA Class 1
·Clinical Chemistry
PENTA
FDA Adverse Event
Injury
·ST. JUDE MEDICAL -NEUROMODULATION·Product code GZB·June 27, 2014
HEARTMATE II SYSTEM CONTROLLER
FDA Adverse Event
Malfunction
·THORATEC CORPORATION·Product code DSQ·December 9, 2010
HUMIDIFIER, RESPIRATORY GAS
FDA Adverse Event
Other
·FISHER & PAYKEL HEALTHCARE LIMITED·Product code BTT·January 16, 2013
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
Synthes Small Notch Titanium Reconstructive Plate set (SNTRP). Ti PLATE/ROD/PLATE 231mm 6HOLES/5.0mm ROD/17HOLES. Orthopedic implant.
FDA Enforcement
Class II
·Terminated·Synthes (USA) Products LLC·November 18, 2015
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