8 results
·
18ms
·
Sources: EU EUDAMED, US FDA
DENTURE PRODUCT X
FDA 510(k)
FDA Class 1
·Dental
MR-5200 FULL DISCLOSURE SYSTEM
FDA 510(k)
FDA Class 2
·Cardiovascular
BAXA PCA INFUSOR
FDA 510(k)
FDA Class 2
·General Hospital
HOMECHOICE CYCLER-REFURBISHED
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - LARGO·Product code FKX·December 3, 2010
CABLE 4M TO CONSOLE FOR EPD
FDA Adverse Event
Malfunction
·SYNTHES OBERDORF·Product code HWE·July 3, 2014
SURGISTOOL
FDA Adverse Event
Malfunction
·STRYKER MEDICAL·Product code FZM·December 6, 2012
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