8 results
·
27ms
·
Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
×
CUTTER SIL-SILICONE IMPRESSION MAT
FDA 510(k)
FDA Class 2
·Dental
Reliance Solo Sterilization Wrap, Reliance Tandem Sterilization Wrap
FDA 510(k)
FDA Class 2
·General Hospital
ELECSYS VITAMIN B12 IMMUNOASSAY, CALSET II AND CALCHECK
FDA 510(k)
FDA Class 2
·Clinical Chemistry
HUDSON/MODIFIED TRINKLE ATTACH
FDA Adverse Event
Malfunction
·STRYKER INSTRUMENTS-KALAMAZOO·Product code ERL·April 21, 2014
LEAD MODEL 302
FDA Adverse Event
Malfunction
·CYBERONICS, INC.·Product code LYJ·September 26, 2012
PRECISION
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC NEUROMODULATION CORP·Product code LGW·July 15, 2010
Model Number U228, VISIONIST CRT-P EL MRI
FDA Enforcement
Class I
·Ongoing·Boston Scientific Corporation·October 22, 2025
ACCOLADE SR SL MRI (Model L310)
FDA Enforcement
Class I
·Ongoing·Boston Scientific Corporation·October 22, 2025