Mds Nordion: FDA filings under this applicant name
FDA lists 8 510(k) clearances under 2 spellings of the applicant name “Mds Nordion” (first 2000, latest 2006), across 4 product codes in 1 review panel. Median 510(k) review time under this name: 31 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 |
|---|---|---|---|
| MOT | Irradiator, Blood To Prevent Graft Versus Host Disease | 3 | 3 |
| IWB | System, Radiation Therapy, Radionuclide | 2 | 2 |
| MUJ | System, Planning, Radiation Therapy Treatment | 2 | 2 |
| JAI | Couch, Radiation Therapy, Powered | 1 | 1 |
Review panels
- Radiology (8)
Most recent Mds Nordion 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K060870 | AVANZA | JAI | 2006-05-15 | 46 |
| K053485 | THERATRON EQUINOX, MODELS 80 CM AND 100 CM | IWB | 2006-03-09 | 84 |
| K051065 | RAYCELL X-RAY BLOOD IRRADIATOR | MOT | 2005-05-26 | 30 |
| K050963 | GAMMACELL 1000 ELITE AND GAMMACELL 3000 ELAN | MOT | 2005-05-20 | 32 |
| K032684 | RAYCELL | MOT | 2003-09-26 | 28 |
| K010682 | HELAX-TMS V 5.1 RADIATION THERAPY TREATMENT PLANNING SYSTEM | MUJ | 2001-06-05 | 90 |
| K011246 | DCM 1.0 | MUJ | 2001-05-23 | 30 |
| K001006 | THERATRON 780C/1000 WITH COMPUTERIZED CONSOLE UPGRADE | IWB | 2000-04-27 | 29 |
Recalls
openFDA lists no recalls under a recalling firm named Mds Nordion.
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.
FDA spellings included
FDA records this applicant under 2 spellings (case, punctuation and legal-suffix variants of one name); this page adds them up. Filings per spelling:
- Mds Nordion (7)
- Mds Nordion, Inc. (1)
Frequently asked questions
How many FDA 510(k) clearances are listed under Mds Nordion?
FDA lists 8 510(k) clearances under 2 spellings of the applicant name “Mds Nordion” (first 2000, latest 2006), 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 Mds Nordion?
The median time from FDA receipt to decision across 510(k)s cleared under the name Mds Nordion is 31 days.
Which FDA product codes appear under Mds Nordion?
The most frequent FDA product codes under this applicant name are MOT (Irradiator, Blood To Prevent Graft Versus Host Disease, 3); IWB (System, Radiation Therapy, Radionuclide, 2); MUJ (System, Planning, Radiation Therapy Treatment, 2).
Next steps
- See all 8 Mds Nordion clearances with predicates and recalls
- Run predicate analysis for product code MOT, Mds Nordion'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.