Smith & Nephew Medical, Ltd.
FDA Regulatory Profile
Summary
- Total Recalls
- 3
- 510(k) Clearances
- 10
- Inspections
- 1
- Compliance Actions
- 0
Known Names
smith and nephew medical, smith and nephew, medical
Recent Recalls
| Number | Class | Product | Date |
|---|
| Z-0516-2025 | Class II | RENASYS EDGE The RENASYS¿ EDGE pump is indicated for patients who would benefit from a suction pu | October 2, 2024 |
| Z-1596-2024 | Class II | RENASYS EDGE 300ML CANISTER WITH Solidifier- Indicated for patients who would benefit from a suction | March 11, 2024 |
| Z-1597-2024 | Class II | RENASYS EDGE 800ML CANISTER WITH Solidifier- Indicated for patients who would benefit from a suction | March 11, 2024 |
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|
| K251826 | RENASYS WOUND+ Dressing Kit with AIRLOCK Technology | September 11, 2025 |
| K243576 | RENASYS Foam Wound Dressing Kit with AIRLOCK Technology and Soft Port; RENASYS Gauze Wound Dressing | February 18, 2025 |
| K231939 | Renasys Edge | May 24, 2024 |
| K190756 | IODOFLEX | December 20, 2019 |
| K190730 | IODOSORB | December 20, 2019 |
| K153209 | RENASYS TOUCH Negative Pressure Wound Therapy, RENASYS TOUCH Canisters, RENASYS TOUCH Carry Bag, Ca | August 4, 2016 |
| K151436 | PICO Single Use Negative Pressure Wound Therapy System | January 28, 2016 |
| K891444 | PERRY* STERILE X-AM* GLOVES | September 19, 1989 |
| K892353 | PERRY* NON-STERILE X-AM* GLOVES | May 25, 1989 |
| K891712 | PERRY* LATEX FLOOR GLOVES | April 27, 1989 |