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Dressing, Wound And Burn, Interactive
FDA product code MGR · Class 3 · Unknown
15
Registered devices
220
Adverse events
7
Recalls
0
510(k) clearances
Devices with this code
Integra® — Integra Lifesciences CorporationIntegra® — Integra Lifesciences CorporationOmnigraft™ — Integra Lifesciences CorporationTransCyte — ORGANOGENESIS INC.Integra® Dermal Regeneration Template — 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 |
|---|---|---|
| 2011-02-21 | Organogenesis, Inc. | Product sterility may be compromised |
| 2011-01-30 | Organogenesis, Inc. | Product sterility compromised |
| 2010-08-02 | Organogenesis, Inc. | Product is contaminated with a yeast identified as Pseudozyma antarctica. |
| 2009-09-27 | Organogenesis, Inc. | Unit contaminated with Staphylococcus epidermidis |
| 2007-12-26 | Organogenesis, Inc. | Contamination: Apligraf units were reported to have contamination in the agarose nutrient medium of some units retained at Organogenesis. Preliminary tests sh |
| 2006-09-29 | Organogenesis, Inc. | Product pH out of specification |
| 2003-05-02 | Smith and Nephew Wound Management (La Jolla) | Did not meet finished device specifications for the DNA criteria. |
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