Panels › General, Plastic Surgery › Product code KPJ · Class 2
Chamber, Oxygen, Topical, Extremity
Regulation 878.5650
0510(k)s in 12 months (23 all time)
0recalls in 12 months (2 all time)
2recalls that name a 510(k)
Top companies in KPJ
| Company | 510(k)s | Recalls |
|---|---|---|
| Stephenson Industries, Inc. | 3 | 0 |
| Hospitak, Inc. | 2 | 0 |
| Ogenix Corporation | 0 | 2 |
| Vaporox, Inc. | 2 | 0 |
| Adjunctive Therapeutics, Inc. | 1 | 0 |
| Aoti , Ltd. | 1 | 0 |
| Ballard Medical Products | 1 | 0 |
| Electrochemical Oxygen Concepts, Inc. | 1 | 0 |
| Gwr Medical, Llp | 1 | 0 |
| Inotec Amd , Ltd. | 1 | 0 |
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Apr 30, 2012 | Ogenix Corporation EPIFLO; Transdermal continuous oxygen therapy device; single use; disposable medical device. Model Number EPIFLO-15. Mfr.By: Neogenix, LLC, dba Ogenix, 3401 Enterprise Pkwy, Suite 340, Beachwood, OH 4 Terminated |
KPJ | K023456 |
| Sep 28, 2006 | Ogenix Corporation Clinical Users Guide (CUG) accompanying the EpiFLO SD, Part #01-100-1000000. The EpiFLO is packaged in a sealed poly-bag that contains: 1) one sterile tyvek packaged pouch containing the cannula, 2) Terminated |
KPJ | K023456 |
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