9 results
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18ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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KEELER PULSAIR 3000 NON CONTACT TONOMETER
FDA 510(k)
FDA Class 2
·Ophthalmic
IMMULITE 2000 3GALLERGY SPECIFIC IGE ASSAY KIT
FDA 510(k)
FDA Class 2
·Immunology
SYSTEMIC LUPUS
FDA 510(k)
FDA Class 2
·Immunology
MENTOR SMOOTH ROUND MODERATE PLUS PROFILE
FDA Adverse Event
Malfunction
·MENTOR TEXAS·Product code FWM·February 21, 2025
ENDO STITCH* 10MM SUTURING DEVICE
FDA Adverse Event
Malfunction
·COVIDIEN, FORMERLY US SURGICAL·Product code KOG·February 7, 2013
HOMECHOICE, DOMESTIC 120V
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - SINGAPORE·Product code FKX·February 15, 2011
CAPSUREFIX NOVUS
FDA Adverse Event
Malfunction
·MPRI·Product code DTB·August 7, 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