National Biological Corp
FDA Regulatory Profile
Summary
- Total Recalls
- 3
- 510(k) Clearances
- 27
- Inspections
- 6
- Compliance Actions
- 1
Recent Recalls
| Number | Class | Product | Date |
|---|
| Z-1683-2017 | Class II | Hand Foot II, UVB-138. One device per box; device is surrounded by foam inserts inside a corrugated | January 27, 2017 |
| Z-1778-2013 | Class III | Dermalight 80 Model Number UVB-080, one unit per box. The Dermalight 80 is a Phototherapy light | April 9, 2013 |
| Z-1779-2013 | Class III | Dermalight 80 Model Number UVB-083, one unit per box. The Dermalight 80 is a Phototherapy light u | April 8, 2013 |
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|
| K070934 | PANOSOL II TRU-BLU, MODEL UBL-417 | May 22, 2007 |
| K041212 | HOUVA 3 PHOTOTHERAPY SYSTEM | June 9, 2004 |
| K982082 | HANDISOL WOUND HEALING | October 28, 1998 |
| K934808 | UVISOL AND UVISOL II | December 16, 1993 |
| K924969 | PHOTOTHERAPY TIMER | February 23, 1993 |
| K924077 | HANDISOL | November 20, 1992 |
| K904428 | PANOSOL II UAB-228 | December 24, 1990 |
| K904426 | PANOSOL II UVA-218 | December 24, 1990 |
| K904427 | PANOSOL II UVB-206 | December 24, 1990 |
| K885029 | HOUVA II UVA/UVB | June 2, 1989 |
| K885026 | HOUVA II UVB | June 2, 1989 |
| K885025 | HOUVA II UVA | January 9, 1989 |
| K882722 | HOUVA-BED | August 30, 1988 |
| K872706 | PANOSOL 2000 624-616 | July 27, 1987 |
| K872650 | PANOSOL 2000 624-604 | July 27, 1987 |
| K872651 | PANOSOL 2000 624-414 | July 27, 1987 |
| K872707 | PANOSOL 2000 624-404 | July 27, 1987 |
| K872649 | HAND/FOOT UVA/UVB 624-224 | July 27, 1987 |
| K872605 | HAND/FOOT UVA 624-218 | July 24, 1987 |
| K872604 | HAND/FOOT 624-208 | July 24, 1987 |