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ARM GUARD
BURLINGTON MEDICAL, LLC · Model TAGCOMBO-SET · UDI-DI 00840186698833
4
510(k) clearances
36
Adverse events
1
Recalls
59
Facilities
Description
ARM GUARD (TAG GUARD&PAD COMBO, CLOSED CELL FOAM SET S/M/L PAIRS)
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.