Cardiff, GB · 5 510(k) clearances · 1 recalls
| Code | Device name | Class | Specialty | Clearances | Most recent |
|---|---|---|---|---|---|
| HGM | System, Monitoring, Perinatal | Class II | Obstetrics/Gynecology | 3 | 2025-09-19 |
| JOW | Sleeve, Limb, Compressible | Class II | Cardiovascular | 1 | 2021-09-03 |
| ITX | — | — | — | 1 | 2021-02-19 |
| Date | Severity | Status | Recall # | Product | Code | Reason |
|---|---|---|---|---|---|---|
| 2022-02-11 | Class II | Terminated | Z-0960-2022 | HUNTLEIGH Disposable intraoperative Probe, 8Mhz (box), REF DIPP10, containing 10 individual Disposable Intraoperative Pr… | — | Faceplate may become detached from the probe body. |
| Date | K-number | Device | Code | Class | Specialty |
|---|---|---|---|---|---|
| 2025-09-19 | K250777 | Sonicaid Team3 | HGM | Class II | Obstetrics/Gynecology |
| 2025-02-03 | K241368 | Sonicaid Team3 | HGM | Class II | Obstetrics/Gynecology |
| 2021-09-03 | K211200 | WoundExpress | JOW | Class II | Cardiovascular |
| 2021-02-19 | K201425 | Disposable Intraoperative Probe (DIOP8) | ITX | — | — |
| 2020-06-24 | K200975 | Sonicaid Team3 Antepartum, Sonicaid Team3 Intrapartum | HGM | Class II | Obstetrics/Gynecology |