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David Scott Company · Model BB-OP850S-COMBO · UDI-DI 15060797550784

510(k) clearances

Adverse events

Recalls

Facilities

Description

Replacement foam O.R. table pad set designed to fit a Berchtold Operon B850 short foot section series table. The Combo Series is a dense supportive foam, a cradling Visco foam, with a layer of Blue Diamond® Gel top layer just below the 4 way stretch covering. 20" foot Section.

Recalls

Date	Firm	Reason
2016-04-19	Berchtold 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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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.