13 results
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29ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Aquilion ONE Self-Propelled Scan Base Kit for IVR-CT, CGBA-034A
FDA 510(k)
FDA Class 2
·Radiology
MEDI
FDA UDI
MEDI MANUFACTURING, INC.·04049772814206·GENUMEDI PT SILVER L III
AVANOS*
FDA UDI
Avanos Medical, Inc.·00193493934171·Single-Shot Epidural Trays - 182223
Halyard
FDA UDI
Avanos Medical, Inc.·10680651934175·
CHALLENGE-EVER
FDA 510(k)
FDA Class 1
·Dental
NEUTROLUMENPN SYSTEM, MODEL 1000
FDA 510(k)
FDA Class 2
·Physical Medicine
BD E-Z SCRUB
FDA Adverse Event
Malfunction
·BD SANDY·Product code GEC·April 18, 2021
TRUEMETRIX
FDA Adverse Event
Malfunction
·TRIVIDIA HEALTH, INC.·Product code NBW·June 27, 2019
XIENCE XPEDITION EVEROLIMUS ELUTING CORONARY STENT SYSTEM
FDA Adverse Event
Injury
·AV-TEMECULA-CT·Product code NIQ·June 21, 2013
DELTA SHUNT KIT, SMALL, PERFORMANCE LEVEL 1
FDA Adverse Event
Malfunction
·MEDTRONIC NEUROSURGERY·Product code JXG·July 12, 2011
*
FDA Adverse Event
FLIGHT MEDICAL LTD.·Product code CBK·July 15, 2008
TRUETRACK
FDA Adverse Event
Malfunction
·TRIVIDIA HEALTH, INC.·Product code NBW·November 21, 2017
Kimberly-Clark Single Shot Epidural Pain Management Trays containing the BD LOR Syringe (BD Code 405198) Product Usage: The device is designed to provide regional anesthesia. The device may contain syringes, needles and drugs
FDA Enforcement
Class II
·Terminated·Kimberly-Clark Corporation·December 25, 2013