Amerx Health Care Corp.
FDA Regulatory Profile
Summary
- Total Recalls
- 10
- 510(k) Clearances
- 3
- Inspections
- 2
- Compliance Actions
- 0
Recent Recalls
| Number | Class | Product | Date |
|---|
| Z-2249-2016 | Class II | Amerigel Hydrogel Wound Dressing Advanced Formula for wound management 1 oz. | May 20, 2016 |
| Z-1797-2015 | Class II | Amerigel Hydrogel Gauze Dressing 2 x 2, A5002. Wound Management. | February 25, 2015 |
| Z-0499-2015 | Class II | Amerigel Daily Dressing Packets Wound management | September 26, 2014 |
| Z-0500-2015 | Class II | Amerigel Saturated Gauze Dressing Wound management | September 26, 2014 |
| Z-0498-2015 | Class II | Amerigel Post-op Surgical Kits Wound management | September 26, 2014 |
| Z-0497-2015 | Class II | Amerigel Hydrogel Wound Dressing Wound management | September 26, 2014 |
| Z-2638-2014 | Class II | Amerigel Wound Dressing Maximum Strength CAT# A2001. Wound management. | July 11, 2014 |
| Z-2639-2014 | Class II | Amerigel Hydrogel Saturated Gauze Dressing; 10 Individually Packaged pads size 2x2 4 Ply Pads; CAT # | July 11, 2014 |
| Z-2641-2014 | Class II | Amerigel Daily Dressing Advanced 3-in-1 Hydrogel; 30 single used foil packets 1g. each; CAT # A2003. | July 11, 2014 |
| Z-2640-2014 | Class II | Amerigel Post-Op Surgical Kits . Kit includes: Amerigel Wound Dressing, Amerigel Wound Wash, 22x2 G | July 11, 2014 |
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|
| K092086 | AMERIGEL WOUND DRESSING PLUS 1/2 OZ. (15G TUBE), MODEL A2025; 1 OZ. (30G TUBE), MODEL A2026; 3 OZ (9 | July 30, 2009 |
| K971918 | AMERIGEL OINTMENT SATURATED WOUND DRESSING | August 12, 1997 |
| K970133 | AMERIGEL OINTMENT | April 14, 1997 |