Teknomed, Inc.: FDA clearances and approvals
Teknomed, Inc. has 7 FDA 510(k) clearances (first 1979, latest 1993), across 4 product codes in 3 review panels. Median 510(k) review time: 207 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 |
|---|---|---|---|
| GEX | Powered Laser Surgical Instrument | 3 | 3 |
| FFK | Lithotriptor, Electro-Hydraulic | 2 | 2 |
| IZF | System, X-Ray, Tomographic | 1 | 1 |
| LNK | Laser For Gastro-Urology Use | 1 | 1 |
Review panels
Most recent Teknomed, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K925395 | TECHNOMED PULSOLITH 4000 LASER SYSTEM | LNK | 1993-05-21 | 207 |
| K920708 | MULTILASE 2500 A | GEX | 1992-11-05 | 261 |
| K913917 | MULTILASE 2100 C, 2100 D | GEX | 1992-11-05 | 429 |
| K913290 | MULTILASE 2100 A | GEX | 1992-02-21 | 212 |
| K895178 | TECHNOMED PULSOLITH LASER SYSTEM | FFK | 1989-10-06 | 57 |
| K890436 | TECHNOMED PULSOLITH LASER SYSTEM | FFK | 1989-03-23 | 55 |
| K790132 | TECNOTOMO | IZF | 1979-02-21 | 29 |
Recalls
openFDA lists no recalls under a recalling firm named Teknomed, Inc..
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 Teknomed, Inc. have?
Teknomed, Inc. has 7 FDA 510(k) clearances (first 1979, latest 1993), across 4 product codes in 3 review panels.
How long does FDA take to clear Teknomed, Inc.'s 510(k)s?
The median time from FDA receipt to decision across Teknomed, Inc.'s cleared 510(k)s is 207 days.
What devices does Teknomed, Inc. make?
Its most frequent FDA product codes are GEX (Powered Laser Surgical Instrument, 3); FFK (Lithotriptor, Electro-Hydraulic, 2); IZF (System, X-Ray, Tomographic, 1).
Has Teknomed, Inc. had device recalls?
openFDA lists no recalls under a recalling firm name matching Teknomed, Inc. Related entities may recall under other names.
Next steps
- See all 7 Teknomed, Inc. clearances with predicates and recalls
- Run predicate analysis for product code GEX, Teknomed, Inc.'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.