19 results
·
22ms
·
Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
×
Intra-Operative Positioning System (IOPS®)
FDA 510(k)
FDA Class 2
·Cardiovascular
ENDO USA
FDA registration
ENDO USA·1 product·🇺🇸 United States
UNSPECIFIED BD INTEGRA¿ SYRINGE
FDA Adverse Event
Malfunction
·BECTON DICKINSON·Product code FMF·December 30, 2022
BD INSYTE¿ AUTOGUARD¿ SHIELDED IV CATHETER
FDA Adverse Event
Malfunction
·BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.·Product code FOZ·December 30, 2022
ONVOY Acetabular System
FDA 510(k)
FDA Class 2
·Orthopedic
Bendit21 Microcatheter
FDA 510(k)
FDA Class 2
·Cardiovascular
BD INSYTE¿ AUTOGUARD¿ SHIELDED IV CATHETER 22GA
FDA Adverse Event
Malfunction
·BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.·Product code FOZ·April 12, 2023
BD VACUTAINER® C&S TRANSFER STRAW KIT
FDA Adverse Event
Malfunction
·BECTON, DICKINSON & CO. (BROKEN BOW)·Product code JSM·July 30, 2019
FLEXIVA (TM) TRACTIP HIGH POWER SINGLE-USE LASER FIBER
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC - MARLBOROUGH·Product code GEX·November 11, 2014
INRATIO
FDA Adverse Event
Malfunction
·ALERE SAN DIEGO, INC.·Product code GJS·July 29, 2011
PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP
FDA Adverse Event
Death
·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OYC·July 23, 2013
BD INSYTE¿ AUTOGUARD¿ SHIELDED IV CATHETER
FDA Adverse Event
Malfunction
·BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.·Product code FOZ·March 6, 2023
Maquet Express Dry Seal Suction OCEAN DRAIN, SINGLE Reference: 2002-400 Intended Use: To evacuate air and/or fluid from the chest cavity or mediastinum. " To help re-establish lung expansion and restore breathing dynamics. " To facilitate postoperative collection and reinfusion of autologous blood from the patients pleural cavity or mediastinal area
FDA Enforcement
Class II
·Terminated·Atrium Medical Corporation·February 22, 2017
BD VACUTAINER® C&S TRANSFER STRAW KIT
FDA Adverse Event
Malfunction
·BECTON, DICKINSON & CO. (BROKEN BOW)·Product code JSM·July 26, 2019
BD INSYTE¿ AUTOGUARD¿ SHIELDED IV CATHETER 22GA
FDA Adverse Event
Malfunction
·BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.·Product code FOZ·March 21, 2023
BD INSYTE¿ AUTOGUARD¿ SHIELDED IV CATHETER
FDA Adverse Event
Malfunction
·BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.·Product code FOZ·January 18, 2023
BD INSYTE¿ AUTOGUARD¿ SHIELDED IV CATHETER 22GA
FDA Adverse Event
Malfunction
·BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.·Product code FOZ·February 10, 2023
BD INSYTE¿ AUTOGUARD¿ IV CATHETER
FDA Adverse Event
Malfunction
·BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.·Product code FOZ·May 12, 2023
BD VACUTAINER® C&S TRANSFER STRAW KIT
FDA Adverse Event
Malfunction
·BECTON, DICKINSON & CO. (BROKEN BOW)·Product code JSM·July 29, 2019