15 results
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33ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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TIBIAL NAIL, STANDARD 10X390 MM
FDA Adverse Event
Malfunction
·STRYKER OSTEOSYNTHESIS KIEL·Product code HSB·March 17, 2010
OMNIFLATOR 7640 MODEL 7-640-00
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
TECHNICON RA(TM) SYSTEMS - MAGNESIUM
FDA 510(k)
FDA Class 1
·Clinical Chemistry
FLUOROCORE 2
FDA 510(k)
FDA Class 2
·Dental
CONVERTBL I.V.DUAL CHANNEL HSP
FDA Adverse Event
Malfunction
·HOSPIRA COSTA RICA LTD.·Product code FRN·December 20, 2011
CONVERTBL I.V..DUAL C
FDA Adverse Event
Malfunction
·HOSPIRA LTD.·Product code FPA·August 13, 2009
PRIMARY PLUMSET PP YSITE 272CM NDEHP
FDA Adverse Event
Malfunction
·HOSPIRA COSTA RICA LTD.·Product code FRN·March 19, 2012
CONVERTBL I.V. DUAL C
FDA Adverse Event
Malfunction
·HOSPIRA COSTA RICA LTD.·Product code FPA·October 15, 2009
CONVERTBL I.V. DUAL CHANNEL HSP
FDA Adverse Event
Malfunction
·HOSPIRA COSTA RICA LTD.·Product code FPA·July 7, 2011
UNK
FDA Adverse Event
Malfunction
·HOSPIRA COSTA RICA LTD.·Product code FPA·October 15, 2009
QUICK FLEX LV LEAD
FDA Adverse Event
Death
·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code OJX·February 28, 2013
ADMIRAL XTREME BALLOON CATHETER
FDA Adverse Event
Malfunction
·INVATEC INNOVATIVE TECHNOLOGIES SPA.·Product code DQY·February 4, 2011
TRACER HYBRID WIRE GUIDE
FDA Adverse Event
Malfunction
·WILSON-COOK MEDICAL INC.·Product code KOG·July 2, 2014
CADD CASSETTE RESERVOIR
FDA Adverse Event
Malfunction
·SMITHS MEDICAL ASD, INC.·Product code FPA·May 11, 2020
CADD Medication Cassette Reservoir, 100mL, FS, Product Code 21-7302-24
FDA Enforcement
Class II
·Ongoing·Smiths Medical ASD Inc.·October 30, 2024