8 results
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19ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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LYPHOCHECK URINE METALS CONTROL, ITEM NO.400, 405
FDA 510(k)
FDA Class 1
·Clinical Toxicology
Epredia
FDA UDI
RICHARD-ALLAN SCIENTIFIC COMPANY·00673693236645·Glyo-Fixx is formulated for use as a histologic...
KODAK EKTACHEM 500 ANALYZER
FDA 510(k)
FDA Class 1
·Clinical Chemistry
3-WAY T 22MM MALE
FDA 510(k)
FDA Class 1
·Anesthesiology
ASSURANT COBALT
FDA Adverse Event
Malfunction
·MEDTRONIC IRELAND·Product code NIO·March 6, 2013
PULSE-GENERATOR, DUAL CHAMBER, IMPLANTABLE
FDA Adverse Event
Malfunction
·MEDTRONIC MILACA, INC.·Product code LWP·August 8, 2014
SPRINT QUATTRO SECURE S
FDA Adverse Event
Malfunction
·MEDTRONIC PUERTO RICO, INC.·Product code LWS·February 15, 2011
OPTETRAK Comprehensive Knee System including OPTETRAK Logic RBK PS Tibial Components (Product Line: 02-012-38-XXXX). NOTE: Information reflects Exactech recall expansion initiated on 02/07/2022.
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·October 13, 2021