7 results
·
18ms
·
Sources: EU EUDAMED, US FDA
ROBINSON KIT - 750014 & 750016
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
SULTAN TOOTH ROOT DESENSITIZER
FDA 510(k)
FDA Class 2
·Dental
Voluson E6, Voluson E8, Voluson E10
FDA 510(k)
FDA Class 2
·Radiology
REPLY
FDA Adverse Event
Malfunction
·SORIN GROUP ITALIA S.R.L. - CRM FACILITY·Product code NVZ·April 25, 2014
LAP-BAND ADJUSTABLE GASTRIC BANDING SYSTEM (UNK SIZE)
FDA Adverse Event
Malfunction
·ALLERGAN·Product code LTI·October 2, 2012
UNKNOWN ASR HEAD
FDA Adverse Event
Injury
·DEPUY INTERNATIONAL, LTD.·Product code KWA·July 23, 2010
ACCOLADE SR SL MRI (Model L310)
FDA Enforcement
Class I
·Ongoing·Boston Scientific Corporation·October 22, 2025