9 results · 18ms · Sources: EU EUDAMED, 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