7 results
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20ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Hope&Her Vaginal Dilators
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
PULPDENT SEMI-GEL ETCH
FDA 510(k)
FDA Class 2
·Dental
EZ-IO Intraosseous Vascular Access System
FDA 510(k)
FDA Class 2
·General Hospital
AML LG STATURE 13.5MM
FDA Adverse Event
Injury
·DEPUY ORTHOPAEDICS, INC.·Product code LPH·November 5, 2008
EXTENSION SET
FDA Adverse Event
Injury
·BAXTER HEALTHCARE - MOUNTAIN HOME·Product code KDJ·August 25, 2011
POWER PRO AMBULANCE COT
FDA Adverse Event
Malfunction
·STRYKER MEDICAL-KALAMAZOO·Product code FPO·July 12, 2013
Model Number L111, ESSENTIO DR SL MRI Pacemaker
FDA Enforcement
Class I
·Ongoing·Boston Scientific Corporation·October 22, 2025