9 results
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22ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Hood (DH-083ST)
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
RADIOTHERAPY SOLUTION BASED ON CR
FDA 510(k)
FDA Class 2
·Radiology
SCANIP; SCANIP: MEDICAL EDITION; SCANIP: MED
FDA 510(k)
FDA Class 2
·Radiology
BD Q-SYTE¿ LUER ACCESS SPLIT-SEPTUM STAND-ALONE DEVICE
FDA Adverse Event
Malfunction
·BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V.·Product code FPA·August 21, 2018
APPLICATION INSTRUMENT FOR STERNAL ZIPFIX
FDA Adverse Event
Malfunction
·SYNTHES HAGENDORF·Product code JDQ·November 11, 2014
RIATA PASSIVE FIXATION
FDA Adverse Event
Injury
·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code NVY·September 10, 2011
GYNECARE TVT RETROPUBIC SYSTEM
FDA Adverse Event
Injury
·ETHICON INC.·Product code OTN·July 23, 2013
BD Q-SYTE¿ LUER ACCESS SPLIT-SEPTUM STAND-ALONE
FDA Adverse Event
Malfunction
·BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V.·Product code FPA·May 15, 2018
Model Number L111, ESSENTIO DR SL MRI Pacemaker
FDA Enforcement
Class I
·Ongoing·Boston Scientific Corporation·October 22, 2025