Carpinteria, CA, US · 1 510(k) clearances · 2 recalls
| Code | Device name | Class | Specialty | Clearances | Most recent |
|---|---|---|---|---|---|
| EWL | Prosthesis, Laryngeal (Taub) | Class II | Ear, Nose, Throat | 1 | 2024-12-18 |
| Date | Severity | Status | Recall # | Product | Code | Reason |
|---|---|---|---|---|---|---|
| 2022-02-21 | Class II | Terminated | Z-1017-2022 | Empower Introducer Sheath with Hydrophilic Coating 21F x 56cm Model: 668782-200 (OUS) | — | Non-intended glue from the hub/shaft bond on the inside ID of the catheter shaft may cause Embolism leading to peripheral ischemia |
| 2022-02-21 | Class II | Terminated | Z-1016-2022 | Empower Introducer Sheath with Hydrophilic Coating 21F x 56cm Model: 668782-100 (US) | — | Non-intended glue from the hub/shaft bond on the inside ID of the catheter shaft may cause Embolism leading to peripheral ischemia |
| Date | K-number | Device | Code | Class | Specialty |
|---|---|---|---|---|---|
| 2024-12-18 | K240763 | FirstFit Surgical Kit | EWL | Class II | Ear, Nose, Throat |