Formatk Systems Ltd.
Tirat Hacarmel Northern, IL
FORMATK SYSTEMS LTD. appears in FDA device records in Tirat Hacarmel Northern, IL. FDA records list 4 510(k) clearances between and , no PMA records and one registered establishment. As of , FDA records show no recalls for this company, and at least one establishment registration is current.
FDA records held for this company
510(k) clearance history
FDA records hold 4 510(k) clearances for Formatk Systems Ltd. between 2016 and 2018. The busiest year on record is 2016, with 3. The most recent is 2018, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 2016 | 3 |
| 2018 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K183307 | Magma Spark Pro (Magma Spark Plus, Alpha) | GEX | Substantially Equivalent | |
| K162781 | Magma Spark | GEX | Substantially Equivalent | |
| K160195 | Forma System, Forma Light System | ONF | Substantially Equivalent | |
| K153566 | Magma System | GEX | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 3011670002 | 3011670002 | FORMATK SYSTEMS LTD. | 3 Hayozma St., Tirat Hacarmel Northern 3903203 IL | 2026 |
Registration numbers link to the FDA registration and listing record for that establishment.
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