Colmed, Ltd.: FDA clearances and approvals
Colmed, Ltd. has 7 FDA 510(k) clearances (first 1979, latest 1981), across 7 product codes in 4 review panels. Median 510(k) review time: 25 days.
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 |
|---|---|---|---|
| DZE | Implant, Endosseous, Root-Form | 1 | 1 |
| EBA | Light, Surgical Headlight | 1 | 1 |
| ELE | Implant, Subperiosteal | 1 | 1 |
| ELS | Splint, Endodontic Stabilizing | 1 | 1 |
| GCY | Apparatus, Suction, Single Patient Use, Portable, Nonpowered | 1 | 1 |
| IRN | Device, Warning, Overload, External Limb, Powered | 1 | 1 |
| JDG | Prosthesis, Hip, Femoral Component, Cemented, Metal | 1 | 1 |
Review panels
- Dental (4)
- Orthopedic (1)
- Physical Medicine (1)
- General and Plastic Surgery (1)
Most recent Colmed, Ltd. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K811209 | JACOB WIRZ TRANSFIXATION PIN | ELS | 1981-06-16 | 46 |
| K810636 | VARIODRAIN | GCY | 1981-05-01 | 52 |
| K810117 | HALOGEN HEADLIGHT SYSTEM | EBA | 1981-02-10 | 25 |
| K801208 | HOLLOW BASKET TITANIUM DENTAL IMPLANT | ELE | 1980-05-28 | 8 |
| K801006 | CHARNLEY DESIGN HIP PROSTHESIS | JDG | 1980-05-20 | 22 |
| K800762 | PS3 TITANIUM SCREW DENTAL IMPLANT | DZE | 1980-05-14 | 37 |
| K792241 | PELIMIT | IRN | 1979-11-30 | 23 |
Recalls
openFDA lists no recalls under a recalling firm named Colmed, Ltd..
Recalling firms are matched to this company by name only (same normalization as the applicant), so related entities that recall under another name are not counted.
Frequently asked questions
How many FDA 510(k) clearances does Colmed, Ltd. have?
Colmed, Ltd. has 7 FDA 510(k) clearances (first 1979, latest 1981), across 7 product codes in 4 review panels.
How long does FDA take to clear Colmed, Ltd.'s 510(k)s?
The median time from FDA receipt to decision across Colmed, Ltd.'s cleared 510(k)s is 25 days.
What devices does Colmed, Ltd. make?
Its most frequent FDA product codes are DZE (Implant, Endosseous, Root-Form, 1); EBA (Light, Surgical Headlight, 1); ELE (Implant, Subperiosteal, 1).
Has Colmed, Ltd. had device recalls?
openFDA lists no recalls under a recalling firm name matching Colmed, Ltd. Related entities may recall under other names.
Next steps
- See all 7 Colmed, Ltd. clearances with predicates and recalls
- Run predicate analysis for product code DZE, Colmed, Ltd.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Companies are grouped by FDA applicant name with punctuation and legal suffixes removed. Review days run from FDA receipt to decision. Not regulatory advice.