Headrest, Neurosurgical

FDA product code HBM · Class I (low risk) · 21 CFR 882.4440 · Neurology

3510(k) clearances
0PMA approvals
2recalls

Manufacturers

510(k) clearances

510(k)DeviceApplicantDecision
K911918Swivel Horseshoe HeadrestHBM · Traditional Codman & Shurtleff, Inc.07/17/1991SE
K911917Codman Pediatric Horseshoe HeadrestHBM · Traditional Codman & Shurtleff, Inc.07/17/1991SE
K822169Surgical Head SupportHBM · Traditional Kelleher Corp.08/20/1982SE

Recalls

RecallProductFirmInitiated
Z-0984-2024 Class IIDual Articulating Headrest, Velcro P/N P141210813, REF BF753Dual-articulating head rest may not stay in place or may fail to lock into position during a patient… Steris Corporation12/12/2023Open, Classified
Z-0983-2024 Class IIDual Articulating Headrest, Pad Ret P/N P141210805, REF BF754Dual-articulating head rest may not stay in place or may fail to lock into position during a patient… Steris Corporation12/12/2023Open, Classified