14 results
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24ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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EPIQ Series Diagnostic Ultrasound Systems; Affiniti Series Diagnostic Ultrasound Systems
FDA 510(k)
FDA Class 2
·Radiology
POSIFLUSH
FDA Adverse Event
Malfunction
·BD MEDICAL (BD WEST) MEDICAL SURGICAL·Product code NGT·April 20, 2026
RESTORE ADVANCED
FDA Adverse Event
Malfunction
·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code LGW·October 18, 2016
Trojan Riviera Personal Lubricant
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
StimSite
FDA 510(k)
FDA Class 2
·Ear, Nose, Throat
POSIFLUSH
FDA Adverse Event
Malfunction
·BD MEDICAL (BD WEST) MEDICAL SURGICAL·Product code NGT·May 1, 2026
BD POSIFLUSH
FDA Adverse Event
Malfunction
·BECTON DICKINSON, S.A.·Product code NGT·March 20, 2026
BD POSIFLUSH
FDA Adverse Event
Malfunction
·BECTON DICKINSON, S.A.·Product code NGT·March 20, 2026
RESTORE ULTRA
FDA Adverse Event
Injury
·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code LGW·May 15, 2015
RESTORE ULTRA
FDA Adverse Event
Malfunction
·MDT PUERTO RICO OPERATIONS·Product code LGW·March 13, 2012
POSIFLUSH
FDA Adverse Event
Malfunction
·BD MEDICAL (BD WEST) MEDICAL SURGICAL·Product code FOZ·April 6, 2026
TOTALCARE
FDA Adverse Event
Malfunction
·HILL-ROM RITTER·Product code FNL·December 2, 2008
MINI-CAP
FDA Adverse Event
Injury
·BAXTER HEALTHCARE - CLEVELAND·Product code KDI·September 16, 2011
PROPLEGE CORONARY SINUS DEVICE
FDA Adverse Event
Malfunction
·EDWARDS LIFESCIENCES·Product code DWF·July 29, 2013