Medical Equipment Development Co., Inc.: FDA filings under this applicant name
FDA lists 7 510(k) clearances under the applicant name “Medical Equipment Development Co., Inc.” (first 1980, latest 1992), across 5 product codes in 3 review panels. Median 510(k) review time under this name: 91 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 |
|---|---|---|---|
| GZT | Retractor, Self-Retaining, For Neurosurgery | 2 | 2 |
| HAW | Neurological Stereotaxic Instrument | 2 | 2 |
| BYI | Percussor, Powered-Electric | 1 | 1 |
| HBL | Holder, Head, Neurosurgical (Skull Clamp) | 1 | 1 |
| IYE | Accelerator, Linear, Medical | 1 | 1 |
Review panels
- Neurology (5)
- Anesthesiology (1)
- Radiology (1)
Most recent Medical Equipment Development Co., Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K911973 | LINEAR ACCELERATOR COLLIMATOR | IYE | 1992-10-15 | 531 |
| K901670 | GNOMOS STEREOTACTIC DEVICE | HAW | 1990-07-03 | 84 |
| K895537 | MODIFIED MEMORY RETRACTOR ARM | GZT | 1989-09-22 | 10 |
| K893911 | MED-TECH RADIOLUCENT HEAD FIXATION SYSTEM | HBL | 1989-08-29 | 91 |
| K874829 | MEDCO MEMORY RETRACTOR SYSTEM | GZT | 1988-03-24 | 121 |
| K874833 | ARC ADAPTER ASSEMBLY | HAW | 1988-03-03 | 100 |
| K802399 | MODEL 2500 PNEUMATIC PERCUSSOR | BYI | 1980-10-23 | 21 |
Recalls
openFDA lists no recalls under a recalling firm named Medical Equipment Development Co., 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.
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.
- Medical Analysis Systems, Inc. (107 510(k)s)
- Medical Components, Inc. (63 510(k)s)
- Medical Advances, Inc. (57 510(k)s)
- Medical Diagnostic Technologies, Inc. (57 510(k)s)
- Medical Devices, Inc. (49 510(k)s)
- Medical Device Technologies, Inc. (46 510(k)s)
- Medical Specialties, Inc. (40 510(k)s)
- Medical Device Inspection Co., Inc. (30 510(k)s)
- Medical Engineering Corp. (28 510(k)s)
- Medical Data Electronics (27 510(k)s)
- Medical Graphics Corp. (25 510(k)s)
- Medical Innovations Corp. (24 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Medical Equipment Development Co., Inc.?
FDA lists 7 510(k) clearances under the applicant name “Medical Equipment Development Co., Inc.” (first 1980, latest 1992), across 5 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 Medical Equipment Development Co., Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Medical Equipment Development Co., Inc. is 91 days.
Which FDA product codes appear under Medical Equipment Development Co., Inc.?
The most frequent FDA product codes under this applicant name are GZT (Retractor, Self-Retaining, For Neurosurgery, 2); HAW (Neurological Stereotaxic Instrument, 2); BYI (Percussor, Powered-Electric, 1).
Next steps
- See all 7 Medical Equipment Development Co., Inc. clearances with predicates and recalls
- Run predicate analysis for product code GZT, Medical Equipment Development Co., 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, 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.