18 results
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23ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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MAGNETOM SYMPHONY A TIM SYSTEM
FDA 510(k)
FDA Class 2
·Radiology
MedGyn Pessary Silicone Donut # 7
FDA UDI
MEDGYN PRODUCTS, INC.·M803050199·Pessary Silicone donut is used treat uterine p...
Merit Medical®
FDA UDI
Merit Medical Systems, Inc.·00884450140994·
keyboard shelter
FDA UDI
Shenzhen Mindray Bio-Medical Electronics Co., Ltd.·06944904098555·
CORTEK MINI LAPAROSCOPE
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
PJUR EROS WATER FORMULATION
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
HEARTWARE VENTRICULAR ASSIST SYSTEM - SHOULDER PACK
FDA Adverse Event
Injury
·HEARTWARE, INC.·Product code DSQ·October 22, 2018
NIM-ECLIPSE® CONTROLLER
FDA Adverse Event
Injury
·MEDTRONIC XOMED, INC·Product code GWF·December 9, 2014
PERFORMA ANGIOGRAPHIC CATHETERS
FDA Adverse Event
Malfunction
·MERIT MEDICAL SYSTEMS, INC.·Product code DQO·April 5, 2013
CARPENTIER-EDWARDS PHYSIO ANNULOPLASTY RING
FDA Adverse Event
Death
·EDWARDS LIFESCIENCES·Product code KRH·May 23, 2008
RES-Q MICRON
FDA Adverse Event
Injury
·GUIDANT ANGLETON/ST. PAUL·Product code LWS·April 12, 2011
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