Toronto Medical Corp.: FDA filings under this applicant name
FDA lists 13 510(k) clearances under the applicant name “Toronto Medical Corp.” (first 1988, latest 1995), across 3 product codes in 1 review panel. Median 510(k) review time under this name: 101 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 |
|---|---|---|---|
| BXB | Exerciser, Powered | 9 | 9 |
| JFA | Exerciser, Finger, Powered | 3 | 3 |
| ILO | Pack, Hot Or Cold, Water Circulating | 1 | 1 |
Review panels
- Physical Medicine (13)
Most recent Toronto Medical Corp. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K950682 | W2 WRIST CPM UNIT | BXB | 1995-09-13 | 211 |
| K945121 | A3 ANKLE CPM UNIT | BXB | 1995-02-17 | 121 |
| K935587 | MULTILINK SHOULDER CPM UNIT | BXB | 1994-12-14 | 393 |
| K935841 | DR KOOL | ILO | 1994-08-29 | 265 |
| K935808 | REVOLUTION LOWER LIMB CPM UNIT | BXB | 1994-03-18 | 106 |
| K925926 | MOBILIMB T1 TOE CPM UNIT | BXB | 1993-03-22 | 119 |
| K900795 | MOBILIMB L4 LOWER LIMB CPM UNIT | BXB | 1990-03-12 | 20 |
| K900466 | MOBILIMB W1 WRIST CPM UNIT | BXB | 1990-03-12 | 40 |
| K900794 | MOBILIMB H3 HAND CPM UNIT | JFA | 1990-03-02 | 10 |
| K895720 | MOBILIMB J1 TMJ CPM UNIT | BXB | 1990-01-04 | 101 |
3 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Toronto Medical Corp..
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 Toronto Medical Corp.?
FDA lists 13 510(k) clearances under the applicant name “Toronto Medical Corp.” (first 1988, latest 1995), across 3 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 Toronto Medical Corp.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Toronto Medical Corp. is 101 days.
Which FDA product codes appear under Toronto Medical Corp.?
The most frequent FDA product codes under this applicant name are BXB (Exerciser, Powered, 9); JFA (Exerciser, Finger, Powered, 3); ILO (Pack, Hot Or Cold, Water Circulating, 1).
Next steps
- See all 13 Toronto Medical Corp. clearances with predicates and recalls
- Run predicate analysis for product code BXB, Toronto Medical Corp.'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.