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Device, Dermal Replacement
FDA product code MDD · Class 3 · Unknown
15
Registered devices
186
Adverse events
3
Recalls
0
510(k) clearances
Devices with this code
Integra® — Integra Lifesciences CorporationIntegra® — Integra Lifesciences CorporationOmnigraft™ — Integra Lifesciences CorporationIntegra® Dermal Regeneration Template — Integra Lifesciences CorporationOmnigraft™ — Integra Lifesciences CorporationIntegra® Dermal Regeneration Template — Integra Lifesciences CorporationOmnigraft™ — Integra Lifesciences CorporationIntegra® Dermal Regeneration Template — Integra Lifesciences CorporationIntegra® Dermal Regeneration Template — Integra Lifesciences CorporationIntegra® Dermal Regeneration Template — Integra Lifesciences CorporationIntegra® — Integra Lifesciences CorporationIntegra® Dermal Regeneration Template — Integra Lifesciences CorporationIntegra® Dermal Regeneration Template — Integra Lifesciences CorporationIntegra® Dermal Regeneration Template — Integra Lifesciences CorporationIntegra® — Integra Lifesciences Corporation
Recent recalls
| Date | Firm | Reason |
|---|---|---|
| 2016-03-11 | Integra LifeSciences Corporation | Integra's post QA release review of historical product release test results for Meshed IDRT products identified the Peel Strength test average result was incorr |
| 2009-01-16 | Integra LifeSciences Corp | Potential for open seals in the inner foil pouch of certain products. The outer seal remains intact and therefore the sterility of the inner pouch is maintaine |
| 2008-07-02 | Integra LifeSciences Corp | Product labeled with an expiration date on May 2010, while the actual expiration date should be April 2010. |
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