Advanced Medical Solutions Ltd.
FDA Regulatory Profile
Summary
- Total Recalls
- 5
- 510(k) Clearances
- 11
- Inspections
- 1
- Compliance Actions
- 0
Recent Recalls
| Number | Class | Product | Date |
|---|
| Z-0617-2025 | Class II | Hollister CalciCare Calcium Alginate Dressing REF 529937R calcium alginate dressings are indicate | October 1, 2024 |
| Z-0619-2025 | Class II | MEDLINE MAXORB EXTRA ALGINATE WOUND DRESSING 4X4 SQUARE REF MSC7044EP MEDLINE MOXORB EXTRA ALBINATE | October 1, 2024 |
| Z-0618-2025 | Class II | McKesson Calcium Alginate Dressing MFR# 3562 Wound dressing indicated for moderate to heavily exu | October 1, 2024 |
| Z-2720-2016 | Class II | ReliaMed¿ Alginate/CMC. Each dressing is packed in a pouch (primary packaging), each pouch is packe | January 15, 2015 |
| Z-2719-2016 | Class II | ReliaMed¿ Silver Alginate/CMC. Each dressing is packed in a pouch (primary packaging), each pouch is | January 15, 2015 |
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|
| K213473 | Antimicrobial Gelling Fiber Dressing with PHMB | October 26, 2023 |
| K210974 | High Performance Antimicrobial Gelling Fiber with Silver | May 12, 2021 |
| K190819 | Silicone PHMB Foam Wound Dressing | July 25, 2019 |
| K183645 | Silver High Performance Dressing | May 29, 2019 |
| K180634 | Surgical Silver Post Operative Dressing | August 7, 2018 |
| K181197 | PHMB Foam Wound Dressing | August 3, 2018 |
| K163062 | PHMB Antimicrobial Foam Wound Dressing | July 25, 2017 |
| K032742 | SILVER FOAM WOUND DRESSING | August 16, 2004 |
| K041316 | ANTIMICROBIAL ALGINATE DRESSING | August 5, 2004 |
| K024298 | ANTIMICROBIAL ALGINATE DRESSING | June 30, 2003 |
| K010245 | ACTIVHEAL SCAR MANAGEMENT DRESSING | April 25, 2001 |