Company ยท US
Axonics, Inc.
FDA 510(k) clearances and medical device recalls filed under this name, 1983 to 1985. Name variants (Inc, Corp, punctuation) are merged.
5510(k) clearances (0 in 12 months)
1recalls (1 in 12 months)
0recalls that name a 510(k)
Product codes
| Code | Device | Records |
|---|
| DGC | Ige, Antigen, Antiserum, Control | 1 |
| EWO | Audiometer | 1 |
| EZW | Stimulator, Electrical, Implantable, For Incontinence | 1 |
| GWF | Stimulator, Electrical, Evoked Response | 1 |
| GWK | Conditioner, Signal, Physiological | 1 |
| JZT | Fluorometer | 1 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|
| Apr 5, 1985 | K843712 | AUDIT TM V Axonics, Inc. | GWF |
| Dec 1, 1983 | K833298 | AUDIT V AX 135 Axonics, Inc. | GWK |
| Aug 12, 1983 | K831870 | ALLERGENETICS FLUORO-FAST READER Axonics, Inc. | JZT |
| Feb 7, 1983 | K822335 | AUDIT Axonics, Inc. | EWO |
| Jan 14, 1983 | K823494 | TOTAL IGE-FAST TEST Axonics, Inc. | DGC |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|
| Oct 16, 2026 | Axonics, Inc. PNE Lead Implant Kit
REF: 1701 Open, Classified |
EZW | None listed |