Leonard Medical, Inc.: FDA filings under this applicant name
FDA lists 7 510(k) clearances under the applicant name “Leonard Medical, Inc.” (first 1986, latest 1995), across 6 product codes in 3 review panels. Median 510(k) review time under this name: 37 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 |
|---|---|---|---|
| HRX | Arthroscope | 2 | 2 |
| EKJ | Burnisher, Operative | 1 | 1 |
| FQO | Table, Operating-Room, Ac-Powered | 1 | 1 |
| FWZ | Operating Room Accessories Table Tray | 1 | 1 |
| LOS | 1 | 1 |
Plus 1 more product codes.
Review panels
- Orthopedic (2)
- General and Plastic Surgery (2)
- Dental (1)
Most recent Leonard Medical, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K951854 | LEONARD ARM - SUPPORT ARM - ENDOSCOPIC ACCESSORY | FQO | 1995-06-21 | 61 |
| K903536 | SMALL JOINT INSTRUMENTS (SCISSOR HANDLE) | LOS | 1990-09-06 | 30 |
| K895685 | SMALL JOINT HAND INSTRUMENTS | HRX | 1989-10-16 | 24 |
| K884308 | MANDIBLE MANIPULATOR | EKJ | 1989-03-31 | 169 |
| K884314 | LEONARD MEDICAL 1.7MM ARTHROSCOPE | HRX | 1989-03-13 | 151 |
| K873139 | VARUS AND VALGUS LEG HOLDER | FWZ | 1987-09-16 | 37 |
| K864117 | SUPPORT ARM | — | 1986-11-03 | 13 |
Recalls
openFDA lists no recalls under a recalling firm named Leonard Medical, 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.
- Leonard Joseph Co. (2 510(k)s)
- Leonard Lorch (1 510(k)s)
- Leonard P. Linkow, D.D.L. (1 510(k)s)
- Leonard Russo Co. (1 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Leonard Medical, Inc.?
FDA lists 7 510(k) clearances under the applicant name “Leonard Medical, Inc.” (first 1986, latest 1995), across 6 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 Leonard Medical, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Leonard Medical, Inc. is 37 days.
Which FDA product codes appear under Leonard Medical, Inc.?
The most frequent FDA product codes under this applicant name are HRX (Arthroscope, 2); EKJ (Burnisher, Operative, 1); FQO (Table, Operating-Room, Ac-Powered, 1).
Next steps
- See all 7 Leonard Medical, Inc. clearances with predicates and recalls
- Run predicate analysis for product code HRX, Leonard Medical, 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.