33 results
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24ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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ACCUSIGN DOA2, DOA, BAR/BZO, BIOSIGN DOA2, BAR/BZO, STATUS DS BAR/BZO, SYVA RAPIDTEST D.A.U. 2 BAR/BZO
FDA 510(k)
FDA Class 2
·Clinical Toxicology
K991088
FDA Adverse Event
Malfunction
·BD CARIBE LTD.·Product code JKA·September 27, 2018
SPIN CHEM REAGENT, DETERMINATION OF AST
FDA 510(k)
FDA Class 2
·Clinical Chemistry
CERAMIC TOTAL HIP BALL HEAD, LARGE TAPER
FDA 510(k)
FDA Class 2
·Orthopedic
SPECIFIC DEVICE NOT REPORTED
FDA Adverse Event
Injury
·EXACTECH, INC.·Product code JDI·June 18, 2024
CUTTING LOOP
FDA Adverse Event
Other
·GYRUS MEDICAL, INC.·Product code HIH·January 26, 2012
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
SYNERGY
FDA Adverse Event
Injury
·MEDTRONIC NEUROMODULATION·Product code LGW·March 6, 2013
SELECT SECURE
FDA Adverse Event
Injury
·MEDTRONIC PUERTO RICO, INC.·Product code NVN·February 15, 2011
CONSULTA CRT-D
FDA Adverse Event
Injury
·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code NIK·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