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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LOCATOR IMPLANT ANCHOR
FDA 510(k)
FDA Class 2
·Dental
LOCATOR Implant Attachment System. The LOCATOR Implant Attachment System is a universal hinge, resilient attachment for endosseous implants. The LOCATOR Implant Attachment System is designed for use with overdentures or partial dentures, retained in whole or in part, by endosseous implants in the mandible or maxilla. FDA 510(k): K994257, K072878
FDA Recall
Terminated
·Zest Anchors LLC·Product code DZE·January 16, 2014
LOCATOR¿ Implant Attachment System. The LOCATOR¿ Implant Attachment System is a universal hinge, resilient attachment for endosseous implants. The LOCATOR¿ Implant Attachment System is designed for use with overdentures or partial dentures, retained in whole or in part, by endosseous implants in the mandible or maxilla. FDA 510(k): K994257, K072878
FDA Enforcement
Class II
·Terminated·Zest Anchors LLC·February 12, 2014
DENTURE PRODUCT X
FDA 510(k)
FDA Class 1
·Dental
TESTOSTERONE SEROZYME(TM) ENZYME IMMUNOASSAY
FDA 510(k)
FDA Class 1
·Clinical Chemistry
SUMMIT DUOFIX TAP SZ2 STD OFF
FDA Adverse Event
Injury
·1818910 DEPUY ORTHOPAEDICS, INC.·Product code LPH·March 8, 2013
SENSIA DR
FDA Adverse Event
Injury
·IPG MFG SWITZERLAND·Product code NVZ·August 8, 2014
C SET: 3-LUMEN 5.5 FR X 13 CM
FDA Adverse Event
Malfunction
·ARROW INTERNATIONAL INC·Product code DQY·January 14, 2011