13 results
·
19ms
·
Sources: EU EUDAMED, US FDA
One-Fil Putty Injectable
FDA 510(k)
FDA Class 2
·Dental
Darby Dental Supply, LLC
FDA UDI
DARBY DENTAL SUPPLY, LLC·00889813051412·ENDO IRRIG SYR SIDE YELL 27GA
POSIFLUSH
FDA Adverse Event
Malfunction
·BD MEDICAL (BD WEST) MEDICAL SURGICAL·Product code NGT·April 20, 2026
K-Y Marilyn Pleasure Gel
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
CHARLOTTE SMALL MTP FUSION PLATE
FDA 510(k)
FDA Class 2
·Orthopedic
POSIFLUSH
FDA Adverse Event
Malfunction
·BD MEDICAL (BD WEST) MEDICAL SURGICAL·Product code NGT·May 1, 2026
BD POSIFLUSH
FDA Adverse Event
Malfunction
·BECTON DICKINSON, S.A.·Product code NGT·March 20, 2026
BD POSIFLUSH
FDA Adverse Event
Malfunction
·BECTON DICKINSON, S.A.·Product code NGT·March 20, 2026
POSIFLUSH
FDA Adverse Event
Malfunction
·BD MEDICAL (BD WEST) MEDICAL SURGICAL·Product code FOZ·April 6, 2026
PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP
FDA Adverse Event
Malfunction
·MEDTRONIC MINIMED·Product code OYC·November 14, 2014
LCS COMP RP INSERT LG+ 10MM
FDA Adverse Event
Injury
·DEPUY RAYNHAM·Product code NJL·September 16, 2011
GRANUFLO
FDA Adverse Event
Death
·FRESENIUS MEDICAL CARE NORTH AMERICA·Product code KPO·July 25, 2013
ACCOLADE DR SL MRI (Model L311)
FDA Enforcement
Class I
·Ongoing·Boston Scientific Corporation·October 22, 2025