9 results
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18ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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PLATELIN(R) EXCEL L
FDA 510(k)
FDA Class 2
·Hematology
Mobile Cart, Flat Pack Servo-air
FDA UDI
Maquet Critical Care AB·07325710004159·
Integra TITAN Reverse Shoulder System
FDA 510(k)
FDA Class 2
·Orthopedic
GUAZE BALLS CAT.#601-720
FDA 510(k)
FDA Unclassified
·Unknown
TI 12-POINT NUT-11MM
FDA Adverse Event
Injury
·SYNTHES USA·Product code NKB·June 18, 2014
HOLOGIC
FDA Adverse Event
Malfunction
·HOLOGIC·Product code LEA·October 19, 2010
MINI TREK CORONARY DILATATION CATHETER
FDA Adverse Event
Malfunction
·AV-TEMECULA-CT·Product code LOX·December 20, 2012
Servo-air Ventilator System-The Servo-air Ventilator System is: Intended for respiratory support, monitoring and treatment of pediatric and adult patients. Model Number: 6882000 (equipped with 6881999 mobile cart)
FDA Recall
Open, Classified
·Getinge Usa Sales Inc·Product code CBK·July 21, 2022
Servo-air Ventilator System-The Servo-air Ventilator System is: Intended for respiratory support, monitoring and treatment of pediatric and adult patients. Model Number: 6882000 (equipped with 6881999 mobile cart)
FDA Enforcement
Class II
·Ongoing·Getinge Usa Sales Inc·August 31, 2022