F Care Systems USA
Miami, FL, US
F CARE SYSTEMS USA appears in FDA device records in Miami, FL. 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 F Care Systems USA between 2021 and 2026. The busiest year on record is 2021, with 1. The most recent is 2026, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 2021 | 1 |
| 2023 | 1 |
| 2025 | 1 |
| 2026 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K253918 | Veineo System (00MEDRF4000TCUS 05CR45iT 06Pedal1St) | GEI | Substantially Equivalent | |
| K252704 | F Care RF System (00MEDRF4000US, 05RAFAELOPROBE, 05SPHERAPROBE, 06OUTPUTKAB, 06Pedal1St) | GEI | Substantially Equivalent | |
| K220725 | HPR45i | GEI | Substantially Equivalent | |
| K210077 | MED RF 4000 | ONQ | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 3008816935 | 3009438986 | F CARE SYSTEMS USA | 755 NE 164TH TERRACE, Miami, FL 33162 US | 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