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Coulmed

Coulmed Products Group LLC · Model TSK10-3PR-WCO · UDI-DI 10810087355576

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

Description

Replacement Pads for SKYTRON 6700, 6701, 6702 O.R. Table. 3 Piece Set, 3” thick, 2-1/2” Standard Foam with 1/2” Pressure Relief Memory Foam. Black Conductive Vinyl Covering. **Custom: Cutouts on Body & Leg Sections**

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.