Verimed Holdings, Inc.: FDA filings under this applicant name
FDA lists 12 510(k) clearances under the applicant name “Verimed Holdings, Inc.” (first 1983, latest 1998), across 4 product codes in 3 review panels. Median 510(k) review time under this name: 210 days. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
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 |
|---|---|---|---|
| HCC | Device, Biofeedback | 5 | 5 |
| HIR | Perineometer | 3 | 3 |
| IPF | Stimulator, Muscle, Powered | 3 | 3 |
| KQX | Goniometer, Ac-Powered | 1 | 1 |
Review panels
Most recent Verimed Holdings, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K981277 | PERIFORM | HIR | 1998-11-20 | 226 |
| K954127 | BIOFEEDBACK DEVICE | HCC | 1995-11-14 | 75 |
| K951969 | MYOEXORCISER II FUAL | HCC | 1995-06-14 | 48 |
| K930670 | PHYACTION 787 | IPF | 1993-07-02 | 143 |
| K922550 | ROMAS (RANGE OF MOTION ASSESSMENT SYSTEM) | KQX | 1992-12-10 | 195 |
| K913912 | VERIMED PERINEOMETER | HIR | 1992-06-16 | 292 |
| K893220 | VERIMED MYOEXORCISER VERISTIM | IPF | 1990-03-07 | 314 |
| K892649 | VERIMED MYOEXORCISER III (MYO III) | HCC | 1989-12-13 | 245 |
| K874212 | VERIMED MYO/PREMS | IPF | 1988-08-08 | 297 |
| K854193 | ELECTRO-MYOGRAPHIC PERINEOMETER | HIR | 1986-06-09 | 237 |
2 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Verimed Holdings, Inc..
Recalling firms are matched to this applicant name by name only (same normalization), so related entities that recall under another name are not counted. A recall count says nothing about how safe one company's devices are compared with another's.
Frequently asked questions
How many FDA 510(k) clearances are listed under Verimed Holdings, Inc.?
FDA lists 12 510(k) clearances under the applicant name “Verimed Holdings, Inc.” (first 1983, latest 1998), across 4 product codes in 3 review panels. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Verimed Holdings, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Verimed Holdings, Inc. is 210 days.
Which FDA product codes appear under Verimed Holdings, Inc.?
The most frequent FDA product codes under this applicant name are HCC (Device, Biofeedback, 5); HIR (Perineometer, 3); IPF (Stimulator, Muscle, Powered, 3).
Next steps
- See all 12 Verimed Holdings, Inc. clearances with predicates and recalls
- Run predicate analysis for product code HCC, Verimed Holdings, Inc.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Each page covers one FDA applicant name (spelling variants such as punctuation and legal suffixes combined); filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.