9 results
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28ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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ACCESS OSTASE QC
FDA 510(k)
FDA Class 1
·Clinical Chemistry
ENDO
FDA UDI
SIRONA Dental Systems GmbH·E27659942770·ENDO 6:1
M1400A TRANSMITTER,M1402 RECEIVER,M1401 MAINFRAME
FDA 510(k)
FDA Class 2
·Cardiovascular
WALLSTENT(R) TRANS BILIARY ENDO W/UNISTEP DELIV SY
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
DEPUY SUMMIT TAPERED HIP STEM WITH POROCOAT
FDA Adverse Event
Injury
·DEPUY ORTHOPAEDICS·Product code LWJ·March 1, 2013
STEALTHSTATION TREON TREATMENT GUIDANCE SYSTEM
FDA Adverse Event
Malfunction
·MEDTRONIC NAVIGATION, INC.·Product code HAW·January 14, 2011
SELECTSECURE
FDA Adverse Event
Injury
·MPRI·Product code NVN·August 8, 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 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