Neuromed, Inc.: FDA clearances and approvals
Neuromed, Inc. has 15 FDA 510(k) clearances (first 1985, latest 1996), across 1 product code in 1 review panel. Median 510(k) review time: 92 days.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 0 | — |
| 2013 | 0 | — |
| 2014 | 0 | — |
| 2015 | 0 | — |
| 2016 | 0 | — |
| 2017 | 0 | — |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| GZB | Stimulator, Spinal-Cord, Implanted (Pain Relief) | 15 | 15 |
Review panels
- Neurology (15)
Most recent Neuromed, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K960728 | ONE STEP CONNECT LEADS (QUATTRODE, OCTRODE, CERVITRODE) | GZB | 1996-05-22 | 90 |
| K930536 | NEUROMED OCTRODE MODEL MNR-88A-B-C NEUROSTIM REC | GZB | 1994-12-15 | 687 |
| K930498 | NEUROMED OCTRODE MODEL MNT-98 NEUROSTIMULATOR TRAN | GZB | 1994-12-12 | 679 |
| K930242 | INTRODE INT-8 | GZB | 1994-02-02 | 379 |
| K921319 | NEUROMED MODEL OCA-30 OCTODE AND MODEL SCA-30 | GZB | 1993-05-05 | 412 |
| K905596 | NEUROMED OCTRODE MODEL MNR-88B/88C NEUROSTIM SYST | GZB | 1991-03-11 | 88 |
| K905255 | NEUROMED MODEL 1992 LS LAMITRODE LEAD | GZB | 1991-01-25 | 65 |
| K903814 | NEUROMED TS8 TEST STIMULATOR | GZB | 1991-01-16 | 149 |
| K901499 | NEUROMED OCTRODE MODEL MNR-88 W/98 ADAPTER NEURO. | GZB | 1990-06-29 | 92 |
| K862915 | MULTISTIM(4-CHANNEL), MULTISTIM-OCTRODE(8 CHANNEL) | GZB | 1986-10-06 | 66 |
5 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Neuromed, Inc..
Recalling firms are matched to this company by name only (same normalization as the applicant), so related entities that recall under another name are not counted.
Frequently asked questions
How many FDA 510(k) clearances does Neuromed, Inc. have?
Neuromed, Inc. has 15 FDA 510(k) clearances (first 1985, latest 1996), across 1 product code in 1 review panel.
How long does FDA take to clear Neuromed, Inc.'s 510(k)s?
The median time from FDA receipt to decision across Neuromed, Inc.'s cleared 510(k)s is 92 days.
What devices does Neuromed, Inc. make?
Its most frequent FDA product codes are GZB (Stimulator, Spinal-Cord, Implanted (Pain Relief), 15).
Has Neuromed, Inc. had device recalls?
openFDA lists no recalls under a recalling firm name matching Neuromed, Inc. Related entities may recall under other names.
Next steps
- See all 15 Neuromed, Inc. clearances with predicates and recalls
- Run predicate analysis for product code GZB, Neuromed, Inc.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Companies are grouped by FDA applicant name with punctuation and legal suffixes removed. Review days run from FDA receipt to decision. Not regulatory advice.