Gme German Medical Engineering GmbH
Willow Creek, MT, US
Gme German Medical Engineering GmbH appears in FDA device records in Willow Creek, MT. FDA records list 6 510(k) clearances between and , no PMA records and no registered establishments. As of , FDA records show no recalls for this company.
FDA records held for this company
- 510(k) clearances
- 6
- PMA records
- 0
- Recall records
- 0
- Registered establishments
- 0
510(k) clearance history
FDA records hold 6 510(k) clearances for Gme German Medical Engineering GmbH between 2014 and 2023. The busiest year on record is 2014, with 1. The most recent is 2023, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 2014 | 1 |
| 2015 | 1 |
| 2018 | 1 |
| 2019 | 1 |
| 2021 | 1 |
| 2023 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K221623 | FlexSys, FlexSys UVB EPL 308 nm, FlexSys UVB EPL lite 308 nm, FlexSys IR 1550 nm | GEX | Substantially Equivalent | |
| K203054 | FlexSys | GEX | Substantially Equivalent | |
| K192269 | TwinScan 808/755 Laser System | GEX | Substantially Equivalent | |
| K180518 | GME LinScan Lite 808 Laser System | GEX | Substantially Equivalent | |
| K150752 | GME ExSys 308 | FTC | Substantially Equivalent | |
| K141063 | LINSCAN 808, LINSCAN 980 | GEX | Substantially Equivalent |
Registered establishments
No FDA establishment registrations recorded against this company.
FDA product codes
Recall records
No recall records for this company in the ingested FDA data.
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain