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Coulmed

Coulmed Products Group LLC · Model TSK04-PR-SectionE · UDI-DI 10810087355064

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

Description

Replacement Table Pads for Skytron 1100 Surgical Table. Section E Only; 2" thick, 1-1/2" Standard Base Foam with 1/2" Pressure Relief Memory Foam...Black Skin-Soft Conductive Covering

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.