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ELITE

STERIS CORPORATION · Model BF466 · UDI-DI 00724995219833

LWG
4
510(k) clearances
36
Adverse events
1
Recalls
59
Facilities

Description

ELITE Supine Headrest, Large is ideal for positioning and stabilizing the patient's head for all supine procedures with the added benefit of pressure management.

Recalls

DateFirmReason
2016-04-19Berchtold Corp.The Surgical Table Cushion (HybriGel Pads) could potentially contain staples that's secure two underlying fabrics, which would be captured on certain scans on patients, such as x-r

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Linked GUDID · 510(k)/PMA · MAUDE · recalls · establishments. Free tier, no card required.

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Data compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.