9 results
·
29ms
·
Sources: EU EUDAMED, US FDA
AUTOMATED ELISA READER LBI 300
FDA 510(k)
FDA Class 1
·Microbiology
LEAVE ACTIVE PFC CVD 10MM SZ5
FDA Adverse Event
Injury
·K830927·Product code JWH·April 18, 2012
T-Line Hernia Mesh
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
SUTURTEK FASTCLOSE SUTURING DEVICE
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
FREESTYLE LITE
FDA Adverse Event
Injury
·Product code NBW·June 25, 2011
VERSACARE BED
FDA Adverse Event
Malfunction
·HILL-ROM, INC.·Product code FNL·May 12, 2014
ESPRIT VENTILATOR
FDA Adverse Event
Malfunction
·RESPIRONICS CALIFORNIA, INC.·Product code CBK·November 13, 2012
ADVIA 1800
FDA Adverse Event
Other
·SIEMENS HEALTHCARE DIAGNOSTICS INC.·Product code JGS·September 7, 2010
ACCOLADE SR SL MRI (Model L310)
FDA Enforcement
Class I
·Ongoing·Boston Scientific Corporation·October 22, 2025