Home › Device types › KPJ
Chamber, Oxygen, Topical, Extremity
FDA product code KPJ · Class 2 · General, Plastic Surgery
26
Registered devices
2
Adverse events
2
Recalls
23
510(k) clearances
Devices with this code
OxySpur® Oxygen Diffusion Dressing — Electrochemical Oxygen Concepts, Inc.OxyGeni® — Electrochemical Oxygen Concepts, Inc.EPIFLO® oxygen delivery cannula — OgenixNumobag Kit — Numotech, Inc.Hyperbox System — AOTI LIMITEDNATROX® Oxygen Wound Therapy — INOTEC AMD LIMITEDOxySpur® lite Oxygen Diffusion Dressings — Electrochemical Oxygen Concepts, Inc.OxySpur® Oxygen Diffusion Dressing — Electrochemical Oxygen Concepts, Inc.OxySpur® Oxygen Diffusion Dressing — Electrochemical Oxygen Concepts, Inc.Hyperbox System — AOTI LIMITEDEPIFLO® — OgenixNATROX® Oxygen Wound Therapy — INOTEC AMD LIMITEDEPIFLO® — OgenixNATROX® Oxygen Wound Therapy — INOTEC AMD LIMITEDNATROX® Oxygen Wound Therapy — INOTEC AMD LIMITEDOxyGeni® Oxygen Delivery Extension Set — Electrochemical Oxygen Concepts, Inc.OxyGeni® Dual Port cannula — Electrochemical Oxygen Concepts, Inc.OxySpur® Oxygen Diffusion Dressing — Electrochemical Oxygen Concepts, Inc.NATROX® Oxygen Wound Therapy — INOTEC AMD LIMITEDNATROX® Oxygen Wound Therapy — INOTEC AMD LIMITEDNATROX® Oxygen Wound Therapy — INOTEC AMD LIMITEDNATROX® Oxygen Wound Therapy — INOTEC AMD LIMITEDAllied Medical LLC — Allied Medical, LLCOxyGeni® Humidicant Pack — Electrochemical Oxygen Concepts, Inc.
Recent recalls
| Date | Firm | Reason |
|---|---|---|
| 2012-04-16 | Ogenix Corporation | Ogenix Initiated a voluntary recall for the EPIFLO-15 devices due to a mislabeling of the expiry date for this lot. Instead of March 2013, this lot carried May |
| 2006-03-24 | Ogenix Corporation | Conflicting instructions are provided in the Instructions for Use (IFU) and the Clinical Users Guide (CUG) which accompany the EpiFLO device. Consequently, the |
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