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Coulmed
Coulmed Products Group LLC · Model TSK07-4PR-B · UDI-DI 10810087355293
4
510(k) clearances
34
Adverse events
1
Recalls
59
Facilities
Description
Replacement Pads for SKYTRON 3500 Surgical Table. Body Section Only; 4" thick. Tier II Pressure Relief Visco Foam with Black Skin-Soft Conductive Covering.
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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Get your free API keyRead the docsData 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.