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Coulmed

Coulmed Products Group LLC · Model TAM06-PR-WOC · UDI-DI 10810087354517

510(k) clearances

Adverse events

Recalls

Facilities

Description

Replacement Pads for AMSCO/STERIS C-Max, 4085, and 5085 (non SRT) O.R. Tables. 3 Piece Set; 2" thick, 1-1/2" High Density Standard Foam with 1/2" Pressure Relief Memory Foam...Black Conductive Vinyl Covering...***Without Cutouts On Leg 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.