Medgyn Products, Inc.
FDA Regulatory Profile
Medgyn Products, Inc. appears in FDA public data with 1 recall, 5 510(k) clearances, 2 FDA inspections, and 0 compliance actions on record. Its most recent recall (D-0917-2018, Class II) was initiated on July 3, 2018. Its most recent 510(k) clearance was granted on November 23, 2015.
Summary
- Total Recalls
- 1
- 510(k) Clearances
- 5
- Inspections
- 2
- Compliance Actions
- 0
Recent Recalls
| Number | Class | Product | Date |
|---|
| D-0917-2018 | Class II | Monsel's Solution (Ferric Subsulfate), 20%, packaged as 12 single application vials and 12 applicato | July 3, 2018 |
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|
| K143669 | MedGyn Straight IUI Catheter, MedGyn Mini IUI Catheter, MedGyn curved, mini IUI Catheter | November 23, 2015 |
| K122973 | AL-106, AL-106SA AND AL-106B MEDGYN DIGITAL VIDEO COLPOSCOPE | June 12, 2013 |
| K945179 | BOTTLE COLLECTION SET | January 26, 1995 |
| K880196 | LAMINARIA | May 6, 1988 |
| K880195 | GYNESCOPE | March 14, 1988 |