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Paper Details

Use of Recalled Devices in New Device Authorizations Under the US Food and Drug Administration's 510(k) Pathway and Risk of Subsequent Recalls.
JAMA
8
2023
510(k), 510(k) devices, Predicates, patient, predicate, predicates, recalled device
Author NameAffiliation
Sanket S DhruvaPhilip R. Lee Institute for Health Policy Studies, University of California san francisco
Sanket S DhruvaSan Francisco Veterans Affairs Medical Center
Joseph S RossCenter for Outcomes Research and Evaluation, Yale New Haven Hospital
Joseph S RossSection of General Internal Medicine and the National Clinician Scholars Program, Yale School of Medicine
Joseph S RossYale School of Public Health
Harlan M KrumholzCenter for Outcomes Research and Evaluation, Yale New Haven Hospital
Harlan M KrumholzYale School of Medicine
Harlan M KrumholzYale School of Public Health
Harlan M KrumholzCenter for Outcomes Research and Evaluation, Yale New Haven Hospital
Harlan M KrumholzYale School of Medicine
Harlan M KrumholzYale School of Public Health
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