7 results
·
26ms
·
Sources: EU EUDAMED, US FDA
MVS UNIT, MODEL SEU-8 AND DEU-8, 80
FDA 510(k)
FDA Class 1
·Dental
E. COLI PNA FISH
FDA 510(k)
FDA Class 1
·Microbiology
Erran Dental Zirconia
FDA 510(k)
FDA Class 2
·Dental
SYSTEM, PERITONEAL, AUTOMATIC DELIVERY
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE·Product code FKX·April 30, 2014
5.0MM X 10FT FIBEROPTIC LIGHT CABLE
FDA Adverse Event
Injury
·STRYKER ENDOSCOPY SAN JOSE·Product code GCJ·October 3, 2012
HARMONIC ACE 36 CM
FDA Adverse Event
Malfunction
·ETHICON ENDO-SURGERY, INC (CINCINNATI)·Product code LFL·January 28, 2008
ACCOLADE SR SL MRI (Model L310)
FDA Enforcement
Class I
·Ongoing·Boston Scientific Corporation·October 22, 2025