9 results
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20ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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INTERACOUSTICS AT235 IMPEDANCE AUDIOMETER
FDA 510(k)
FDA Class 2
·Ear, Nose, Throat
NA ALPHA 1 MICROGLOBULIN KIT
FDA 510(k)
FDA Class 2
·Immunology
HYPAFIX DRESSING RETENTION SHEET
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
CAREFUSION ALARIS PUMP
FDA Adverse Event
Injury
·CAREFUSION·Product code FRN·February 28, 2013
CVC SET:3-LUMEN 12 FR X 20 CM
FDA Adverse Event
Malfunction
·ARROW INTERNATIONAL INC·Product code DQY·January 14, 2011
TRILOGY 100
FDA Adverse Event
Malfunction
·RESPIRONICS INC.·Product code CBK·July 23, 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
BARD Dynamic Deca Steerable, Product Number 201101; REPROCESSED ELECTROPHYSIOLOGY CATHETER
FDA Enforcement
Class II
·Ongoing·Stryker Sustainability Solutions·May 20, 2026