9 results
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19ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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CONCEPT FIBER OPTIC CANALICULUS INTUBA
FDA 510(k)
FDA Class 1
·Ophthalmic
SternalPlate Expansion
FDA 510(k)
FDA Class 2
·Orthopedic
ENFANTTM
FDA 510(k)
FDA Class 2
·Neurology
HEARTMATE II LVAS
FDA Adverse Event
Injury
·THORATEC CORP.·Product code DSQ·November 19, 2012
GEMSTR 7 THPY ALT ST
FDA Adverse Event
Malfunction
·HOSPIRA COSTA RICA LTD.·Product code FRN·March 14, 2014
INRATIO
FDA Adverse Event
Injury
·ALERE SAN DIEGO, INC.·Product code GJS·September 20, 2010
SUREFORM
FDA Adverse Event
Injury
·INTUITIVE SURGICAL, INC·Product code NAY·January 12, 2024
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