7 results
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27ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Gastrointestinal Boundary Identifier (GIBI HD)
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
STAY FRESH SKIN FOLD MANAGEMENT TEXTILE
FDA 510(k)
FDA Class 1
·General Hospital
SMART CONTROL NITINOL STENT TRANSHEPATIC BILIARY SYSTEM
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
840 VENTILATOR
FDA Adverse Event
Injury
·COVIDIEN·Product code CBK·November 3, 2014
ACCU-CHEK ® AVIVA TEST STRIPS
FDA Adverse Event
Malfunction
·ROCHE DIAGNOSTICS·Product code LFR·August 24, 2011
4000CMS
FDA Adverse Event
Malfunction
·MOOG DEVICE GROUP·Product code FRN·July 5, 2013
Model Number L111, ESSENTIO DR SL MRI Pacemaker
FDA Enforcement
Class I
·Ongoing·Boston Scientific Corporation·October 22, 2025