30 results
·
37ms
·
Sources: EU EUDAMED, US FDA
RLP CHOLESTEROL IMMUNOSEPARATION ASSAY
FDA 510(k)
FDA Class 1
·Clinical Chemistry
K991088
FDA Adverse Event
Malfunction
·BD CARIBE LTD.·Product code JKA·September 27, 2018
COMPLETE CONTROL System Gen2
FDA 510(k)
FDA Class 2
·Neurology
SPIN CHEM, DETERMINATION OF ALT (GPT)
FDA 510(k)
FDA Class 1
·Clinical Chemistry
BD VACUTAINER® SAFETY-LOK¿ BLOOD COLLECTION SET WITH PRE-ATTACHED HOLDER
FDA Adverse Event
Malfunction
·BECTON, DICKINSON & CO., (BD)·Product code JKA·February 6, 2024
BD VACUTAINER® SAFETY-LOK¿ BLOOD COLLECTION SET WITH PRE-ATTACHED HOLDER
FDA Adverse Event
Malfunction
·BECTON, DICKINSON & CO., (BD)·Product code JKA·December 15, 2023
BD VACUTAINER® SAFETY-LOK¿ BLOOD COLLECTION SET WITH PRE-ATTACHED HOLDER
FDA Adverse Event
Malfunction
·BECTON, DICKINSON & CO., (BD)·Product code JKA·March 22, 2024
BD VACUTAINER® BLOOD COLLECTION SET WITH LUER ADAPTER
FDA Adverse Event
Malfunction
·BECTON DICKINSON·Product code JKA·May 22, 2018
SYNCHROMED II
FDA Adverse Event
Injury
·MDT PUERTO RICO OPERATIONS CO·Product code LKK·March 6, 2013
SIGMA 300 DR
FDA Adverse Event
Injury
·MEDTRONIC MED REL, INC.·Product code DXY·February 15, 2011
ATTAIN STARFIX
FDA Adverse Event
Injury
·MPRI·Product code OJX·August 8, 2014
BD VACUTAINER® LUER-LOK¿ ACCESS DEVICE
FDA Adverse Event
Malfunction
·BD CARIBE LTD.·Product code JKA·December 4, 2017
BD VACUTAINER® BLOOD TRANSFER DEVICE HOLDER
FDA Adverse Event
Malfunction
·BECTON DICKINSON & CO (FRANKLIN LAKES)·Product code JKA·January 7, 2026
BD VACUTAINER® BLOOD TRANSFER DEVICE HOLDER
FDA Adverse Event
Malfunction
·BECTON DICKINSON & CO (FRANKLIN LAKES)·Product code JKA·January 14, 2026
BD Vacutainer Multiple Sample and Direct Draw Luer Adapter BD Franklin Lakes, NJ 07417 USA A sterile non-invasive device used to connect venous access devices such as needles, blood collection sets, ad infusion sets to blood collection tubes.
FDA Enforcement
Class II
·Terminated·Becton Dickinson & Company·August 14, 2013
BD VACUTAINER® SAFETY-LOK¿ BLOOD COLLECTION SET
FDA Adverse Event
Malfunction
·BECTON DICKINSON·Product code JKA·February 8, 2024
BD VACUTAINER® SAFETY-LOK¿ BLOOD COLLECTION SET
FDA Adverse Event
Injury
·BECTON DICKINSON·Product code JKA·April 3, 2024
BD VACUTAINER® SAFETY-LOK¿ BLOOD COLLECTION SET
FDA Adverse Event
Malfunction
·BECTON DICKINSON·Product code JKA·January 26, 2024
BD VACUTAINER® SAFETY-LOK¿ BLOOD COLLECTION SET
FDA Adverse Event
Malfunction
·BECTON DICKINSON·Product code JKA·December 6, 2023
BD VACUTAINER® BLOOD TRANSFER DEVICE
FDA Adverse Event
Malfunction
·BECTON DICKINSON & CO (FRANKLIN LAKES)·Product code JKA·March 18, 2026