32 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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SALTER LABS PEP DEVICE
FDA 510(k)
FDA Class 2
·Anesthesiology
K991088
FDA Adverse Event
Malfunction
·BD CARIBE LTD.·Product code JKA·September 27, 2018
PANTA NAIL (DIA. 10MM), PANTA NAIL XL
FDA 510(k)
FDA Class 2
·Orthopedic
CAPSTONE Spinal System, CLYDESDALE PTC Spinal System, CRESCENT Spinal System, CRESCENT Spinal System Titanium, DIVERGENCE-L Anterior/Oblique Lumbar Fusion System
FDA 510(k)
FDA Class 2
·Orthopedic
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
MANUAL FEED ADULT HUMIDIFICATION CHAMBER
FDA Adverse Event
Malfunction
·FISHER & PAYKEL HEALTHCARE LTD·Product code BTT·March 6, 2013
CAPSUREFIX MRI SURESCAN
FDA Adverse Event
Injury
·MPRI·Product code NVN·August 8, 2014
CAPSUREFIX NOVUS
FDA Adverse Event
Malfunction
·MEDTRONIC PUERTO RICO, INC.·Product code DTB·February 15, 2011
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