9 results
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20ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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TINSDALE ENRICHMENT
FDA 510(k)
FDA Class 1
·Microbiology
POWERED WHEELCHAIR
FDA Adverse Event
Malfunction
·UNKNOWN·Product code ITI·June 19, 2013
MECHANICAL (MANUAL) WHEELCHAIR
FDA Adverse Event
Malfunction
·CHAMPION MANUFACTURING·Product code IOR·September 6, 2013
B.BRAUN PREMIXED DIALYSATE
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
SABOURAND DEXTROSE AGAR
FDA 510(k)
FDA Class 1
·Microbiology
CYTOMICS FC 500 MPL FLOW CYTOMETER
FDA Adverse Event
Malfunction
·BECKMAN COULTER·Product code GKZ·May 27, 2014
ADVANIX¿ BILIARY
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC - SPENCER·Product code FGE·November 15, 2012
REVEAL LINQ
FDA Adverse Event
Malfunction
·IPG MFG SWITZERLAND·Product code DSI·June 10, 2015
Unify Quadra, Sterile EO, Model #/ Part #: CD3249-40/100036404, 100038435, CD3249-40Q/100036407, 100038436, CD3251-40/100036405, 100038095, 100038226, 100038437, 100038451, 100072563, CD3251-40Q/100036408, 100038214, 100038230, 100038407, 100038442, 100072564, CD3255-40/100038224, CD3255-40Q/100036514
FDA Enforcement
Class II
·Terminated·St Jude Medical Inc.·July 4, 2018