8 results
·
18ms
·
Sources: EU EUDAMED, US FDA
IRRIGATION TRAY
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
Magnesium
FDA 510(k)
FDA Class 1
·Clinical Chemistry
ONEPLANT DENTAL IMPLANT SYSTEM
FDA 510(k)
FDA Class 2
·Dental
CURRENT RF DR
FDA Adverse Event
Injury
·ST. JUDE MEDICAL, INC., CRMD·Product code LWS·April 30, 2014
CONCERTO CRT-D DR
FDA Adverse Event
Injury
·MEDTRONIC MED REL, INC.·Product code NIK·October 11, 2012
CONICAL LOCK NUT, 8MM
FDA Adverse Event
Malfunction
·DEPUY SYNTHES SPINE·Product code NKB·May 19, 2015
ALINITY C MAGNESIUM
FDA Adverse Event
Malfunction
·ABBOTT IRELAND DIAGNOSTICS DIVISION·Product code JGJ·February 16, 2026
PROPONENT DR SL (Model L201)
FDA Enforcement
Class I
·Ongoing·Boston Scientific Corporation·October 22, 2025