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Coulmed

Coulmed Products Group LLC · Model TAM11-PR · UDI-DI 10810087354548

LWG
4
510(k) clearances
34
Adverse events
1
Recalls
59
Facilities

Description

Replacement Pads for Amsco Uro-Endo 1100 OR Table, 2 Piece Set, 2" Thick, 1/2" Pressure Relief Memory Foam, 1-1/2" Standard Base 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.