18 results
·
21ms
·
Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
×
Ion Endoluminal System (Ion Fully Articulating Catheter), Ion Endoluminal System (Ion Peripheral Vision Probe)
FDA 510(k)
FDA Class 2
·Ear, Nose, Throat
IMMUNOCARD C. DIFFICILE GDH
FDA 510(k)
FDA Class 1
·Microbiology
POWDER FREE NEOPRENE EXAMINATION GLOVES, NON STERILE
FDA 510(k)
FDA Class 1
·General Hospital
BD SMARTSITE¿ VIALSHIELD CLOSED VIAL ACCESS DEVICE, 13 MM
FDA Adverse Event
Malfunction
·BECTON DICKINSON·Product code LHI·January 25, 2022
BD SMARTSITE 13MM CLOSED VIAL ACCESS DEVICE
FDA Adverse Event
Malfunction
·BECTON DICKINSON·Product code FPA·January 25, 2022
BD SMARTSITE¿ VIALSHIELD CLOSED VIAL ACCESS DEVICE
FDA Adverse Event
Malfunction
·BECTON DICKINSON·Product code FPA·January 25, 2022
BD SMARTSITE¿ VIALSHIELD CLOSED VIAL ACCESS DEVICE, 13 MM
FDA Adverse Event
Malfunction
·BECTON DICKINSON·Product code LHI·February 24, 2022
BD SMARTSITE¿ VIALSHIELD CLOSED VIAL ACCESS DEVICE, 13 MM
FDA Adverse Event
Malfunction
·BECTON DICKINSON·Product code LHI·April 16, 2022
BD SMARTSITE¿ VIALSHIELD CLOSED VIAL ACCESS DEVICE, 13 MM
FDA Adverse Event
Malfunction
·BECTON DICKINSON·Product code LHI·July 29, 2022
BD SMARTSITE¿ VIALSHIELD CLOSED VIAL ACCESS DEVICE
FDA Adverse Event
Malfunction
·BECTON DICKINSON·Product code FPA·July 29, 2022
BD SMARTSITE¿ VIALSHIELD CLOSED VIAL ACCESS DEVICE, 13 MM
FDA Adverse Event
Malfunction
·BECTON DICKINSON·Product code LHI·February 23, 2022
ETHICON LIGAMAX 5MM
FDA Adverse Event
Injury
·ETHICON ENDO-SURGERY·Product code GDO·October 24, 2008
LIFEVEST WCD 3100 SYSTEM
FDA Adverse Event
Malfunction
·ZOLL LIFECOR CORPORATION·Product code MVK·July 8, 2011
TOTAL ASR FEM IMP SIZE 51
FDA Adverse Event
Injury
·DEPUY INTL., LTD. - 8010379·Product code KXA·July 8, 2013
OSV II
FDA Adverse Event
Injury
·INTEGRA NEUROSCICENCS IMPLANTS SA·Product code JXG·June 9, 2021
paraPAC plus 310 ventilator kit with internal PEEP and CPAP, Item Number P310N
FDA Enforcement
Class I
·Ongoing·Smiths Medical ASD Inc.·October 2, 2024
smiths medical Pneupac paraPAC plus 310 ventilator kit with PEEP and CPAP, REF P310NUS
FDA Enforcement
Class I
·Ongoing·Smiths Medical ASD Inc.·March 27, 2024
Model Number L211 PROPONENT DR SL MRI Pacemaker
FDA Enforcement
Class I
·Ongoing·Boston Scientific Corporation·October 22, 2025