9 results · 20ms · Sources: EU EUDAMED, 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