Midwest: FDA filings under this applicant name
FDA lists 13 510(k) clearances under the applicant name “Midwest” (first 1976, latest 1986), across 4 product codes in 1 review panel. Median 510(k) review time under this name: 12 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 |
|---|---|---|---|
| EAY | Light, Fiber Optic, Dental | 5 | 5 |
| EFB | Handpiece, Air-Powered, Dental | 5 | 5 |
| EGS | Handpiece, Contra- And Right-Angle Attachment, Dental | 2 | 2 |
| EBF | Material, Tooth Shade, Resin | 1 | 1 |
Review panels
- Dental (13)
Most recent Midwest 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K863677 | TRADITION HIGH SPEED HANDPIECE | EFB | 1986-10-06 | 17 |
| K850344 | AM-40 POWER OPTIC AIR MOTOR POWER OPTIC CONTRA ANG | EGS | 1985-03-25 | 56 |
| K792445 | MW STRAIGHT ATTACHMENT | EGS | 1979-12-06 | 6 |
| K792304 | MW-8000 | EFB | 1979-11-27 | 11 |
| K792303 | MW 8000-I | EBF | 1979-11-27 | 11 |
| K792302 | LS-100 | EFB | 1979-11-27 | 11 |
| K791771 | ORALUMINATOR III AUTO-LIGHT | EAY | 1979-11-20 | 74 |
| K791733 | LIGHT-PAK | EAY | 1979-10-23 | 56 |
| K790113 | MIDWEST 1000 | EFB | 1979-02-26 | 38 |
| K781878 | LIGHT, INSIDE | EAY | 1978-12-29 | 53 |
3 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Midwest.
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.
Other FDA applicant names starting with the same word
FDA records these as separate applicants. Some may belong to the same corporate group and some may not; their filings are not included in the counts above.
- Midwest City Hearing Aid Center (12 510(k)s)
- Midwest Rf, LLC (9 510(k)s)
- Midwest Orthodontic Mfg. (7 510(k)s)
- Midwest Dental Products Corp. (5 510(k)s)
- Midwest Metabolic Support Group (4 510(k)s)
- Midwest Reprocessing Center, LLC (4 510(k)s)
- Midwest Analog & Digital, Inc. (3 510(k)s)
- Midwest Implant Sales, Inc. (3 510(k)s)
- Midwest X-Ray Equipment Co. (3 510(k)s)
- Midwest Eye Laboratories, Inc. (2 510(k)s)
- Midwest Development (1 510(k)s)
- Midwest Marketing Service (1 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Midwest?
FDA lists 13 510(k) clearances under the applicant name “Midwest” (first 1976, latest 1986), across 4 product codes in 1 review panel. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Midwest?
The median time from FDA receipt to decision across 510(k)s cleared under the name Midwest is 12 days.
Which FDA product codes appear under Midwest?
The most frequent FDA product codes under this applicant name are EAY (Light, Fiber Optic, Dental, 5); EFB (Handpiece, Air-Powered, Dental, 5); EGS (Handpiece, Contra- And Right-Angle Attachment, Dental, 2).
Next steps
- See all 13 Midwest clearances with predicates and recalls
- Run predicate analysis for product code EAY, Midwest'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, with punctuation and legal suffixes removed; filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.