North Coast Medical Inc
FDA Regulatory Profile
North Coast Medical Inc appears in FDA public data with 3 recalls — including 2 Class I (most serious) —, 1 510(k) clearance, 6 FDA inspections, and 0 compliance actions on record. Its most recent recall (Z-0125-2024, Class II) was initiated on August 18, 2023. Its most recent 510(k) clearance was granted on November 4, 2005.
Summary
- Total Recalls
- 3 (2 Class I)
- 510(k) Clearances
- 1
- Inspections
- 6
- Compliance Actions
- 0
Recent Recalls
| Number | Class | Product | Date |
|---|
| Z-0125-2024 | Class II | Gladiator, Wrist & Thumb Orthosis, Part Numbers: NC86650 (Small/Left), NC86651 (Small/Right), NC866 | August 18, 2023 |
| Z-2582-2021 | Class I | Norco Ultrasound Gel, Item/Description: NC70479/Norco Ultrasound Gel, 250 mL; NC70479/North Coast Ul | August 27, 2021 |
| Z-2583-2021 | Class I | EcoLotion Transmission Lotion, used in ultrasound procedures. Item/Description: NC70481/Eco Lotion | August 27, 2021 |
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|
| K052019 | NORTH COAST BUFFERED IONTOPHORESIS ELECTRODE | November 4, 2005 |