Company ยท US
Regenesis Biomedical, Inc.
FDA 510(k) clearances and medical device recalls filed under this name, 1997 to 2023. Name variants (Inc, Corp, punctuation) are merged.
4510(k) clearances (0 in 12 months)
1recalls (0 in 12 months)
1recalls that name a 510(k)
Product codes
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| May 24, 2023 | K223620 | Reprieve by RegenesisTM Regenesis Biomedical, Inc. | IMJ |
| Dec 13, 2013 | K131979 | PROVANT THERAPY SYSTEM Regenesis Biomedical, Inc. | ILX |
| Apr 7, 2010 | K091791 | PROVANT SYSTEM, MODEL 4201 Regenesis Biomedical, Inc. | ILX |
| Oct 21, 1997 | K972093 | REGENESIS MODEL 42 Regenesis Biomedical, Inc. | ILX |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jan 26, 2009 | Regenesis Biomedical Inc Regenesis Biomedical PROVANT Wound
Therapy System, Model 4201 - The Provant Wound Therapy System is a solid-state, fixed-power output radio frequency generator and transmitter designed to operate at t Terminated |
ILX | K972093 |