16 results
·
22ms
·
Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
×
WOMED NICRO-CRAFT POWER SYSTEM
FDA 510(k)
FDA Class 2
·Ear, Nose, Throat
Novalung System
FDA 510(k)
FDA Class 2
·Cardiovascular
LUNG VOLUME & PRESSURE MONITOR
FDA 510(k)
FDA Class 2
·Anesthesiology
BD VACUTAINER® CPT¿ NH: ~130 IU FICOLL¿: 2.0ML
FDA Adverse Event
Malfunction
·BECTON, DICKINSON & CO.·Product code JCF·June 6, 2018
BD VACUTAINER® CPT¿ NH: ~130 IU FICOLL¿: 2.0ML
FDA Adverse Event
Malfunction
·BECTON, DICKINSON & CO.·Product code JCF·June 7, 2018
BD VACUTAINER® CPT¿ NH: ~130 IU FICOLL¿: 2.0ML
FDA Adverse Event
Malfunction
·BECTON, DICKINSON & CO.·Product code JCF·June 6, 2018
BD VACUTAINER® CPT¿ NH: ~130 IU FICOLL¿: 2.0ML
FDA Adverse Event
Malfunction
·BECTON, DICKINSON & CO.·Product code JCF·April 27, 2018
BD VACUTAINER® CPT¿ NH: ~130 IU FICOLL¿: 2.0ML
FDA Adverse Event
Malfunction
·BECTON, DICKINSON & CO.·Product code JCF·April 16, 2018
G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code MDS·May 5, 2014
SPRINT FIDELIS
FDA Adverse Event
Injury
·MEDTRONIC PUERTO RICO, INC.·Product code LWS·October 15, 2012
CONCERTO CRT-D DR
FDA Adverse Event
Injury
·MEDTRONIC MED REL, INC.·Product code NIK·August 10, 2010
BD VACUTAINER® CPT¿ NH: ~130 IU FICOLL¿: 2.0ML
FDA Adverse Event
Malfunction
·BECTON, DICKINSON & CO.·Product code JCF·June 5, 2018
PALL ULTIPOR 25 BREATHING SYSTEM FILTER
FDA Adverse Event
Injury
·PALL NEWQUAY·Product code CAH·July 13, 2018
PALL ULTIPOR 100 BREATHING SYSTEM FILTER
FDA Adverse Event
Injury
·PALL NEWQUAY·Product code CAH·April 18, 2017
PROTECT SLEEVE 13 F/RETROGR-APPROACH
FDA Adverse Event
Malfunction
·WRIGHTS LANE SYNTHES USA PRODUCTS LLC·Product code FZX·June 29, 2018
ACCOLADE SR SL MRI (Model L310)
FDA Enforcement
Class I
·Ongoing·Boston Scientific Corporation·October 22, 2025