MPM Medical LLC
FDA Regulatory Profile
MPM Medical LLC appears in FDA public data with 1 recall — including 1 Class I (most serious) —, 9 510(k) clearances, 5 FDA inspections, and 0 compliance actions on record. Its most recent recall (D-0118-2021, Class I) was initiated on November 17, 2020. Its most recent 510(k) clearance was granted on May 10, 2006.
Summary
- Total Recalls
- 1 (1 Class I)
- 510(k) Clearances
- 9
- Inspections
- 5
- Compliance Actions
- 0
Recent Recalls
| Number | Class | Product | Date |
|---|
| D-0118-2021 | Class I | REGENECARE HA (Lidocaine HCL 2%) Topical Anesthetic Hydrogel, Net Wt. 3 oz. (85 g), Manufactured Fo | November 17, 2020 |
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|
| K060340 | ORAMAGIC PLUS ORAL WOUND RINSE | May 10, 2006 |
| K024180 | ORAMAGICRX ORAL WOUND RINSE | March 14, 2003 |
| K020540 | REGENECARE WOUND GEL | November 1, 2002 |
| K992074 | MPM REGENECARE WOUND GEL | December 23, 1999 |
| K962160 | MPM HYDROGEL DRESSING (NON-STERILE) | June 26, 1996 |
| K952276 | MPM HYDROGEL DRESSING | June 30, 1995 |
| K942798 | MPM HYDROGEL | July 11, 1994 |
| K930560 | MPM HYDROGEL SATURATED DRESSING | July 8, 1993 |
| K926044 | MPM WET DRESSING (SALINE) | April 8, 1993 |