39 results
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30ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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CAPNOCHECK II, MODEL 8400
FDA 510(k)
FDA Class 2
·Anesthesiology
K991088
FDA Adverse Event
Malfunction
·BD CARIBE LTD.·Product code JKA·September 27, 2018
Exciplex
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
CENTRY 2 SYSTEM #016, 103, 016, 104
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
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
·MEDTRONIC NEUROMODULATION·Product code LKK·March 6, 2013
SPRINT QUATTRO SECURE
FDA Adverse Event
Injury
·MEDTRONIC PUERTO RICO, INC.·Product code LWS·February 15, 2011
REVEAL LINQ
FDA Adverse Event
Injury
·IPG MFG SWITZERLAND·Product code DSI·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
PCCO MONITORING KIT
FDA Adverse Event
Malfunction
·PULSION MEDICAL SYSTEMS SE·Product code KRB·July 30, 2025
PCCO MONITORING KIT
FDA Adverse Event
Malfunction
·PULSION MEDICAL SYSTEMS SE·Product code KRB·November 24, 2025
PCCO MONITORING KIT
FDA Adverse Event
Malfunction
·PULSION MEDICAL SYSTEMS SE·Product code KRB·July 15, 2025
BD VACUTAINER® SAFETY-LOK¿ BLOOD COLLECTION SET
FDA Adverse Event
Malfunction
·BECTON DICKINSON·Product code JKA·February 8, 2024
PCCO MONITORING KIT
FDA Adverse Event
Malfunction
·PULSION MEDICAL SYSTEMS SE·Product code KRB·September 9, 2025