8 results
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19ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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CONTACT-K APTT REAGENT
FDA 510(k)
FDA Class 2
·Hematology
4.5 F LITHOTRIPTOR ELECTRODE
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
INFUSION PUMP #AS*6H
FDA 510(k)
FDA Class 2
·General Hospital
ONETOUCHPING GLUCOSEMGMTSYSTEM
FDA Adverse Event
Malfunction
·ANIMAS CORPORATION·Product code LZG·May 27, 2014
ECHELON*FLEX60 COMPACT
FDA Adverse Event
Injury
·ETHICON ENDO-SURGERY, LLC.·Product code GDW·November 15, 2012
PRECISE RX NITINOL STENT
FDA Adverse Event
Death
·CORDIS DE MEXICO·Product code FGE·September 14, 2010
Zimmer, Cuff Tourniquet Dual Hose Single Bladder Maroon Reprocessed by Sterilmed, Sterile EO, Rx only.
FDA Enforcement
Class II
·Terminated·STERILMED, INC.·December 16, 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