Company ยท US
Amerx Health Care Corp.
FDA 510(k) clearances and medical device recalls filed under this name, 1997 to 2009. Name variants (Inc, Corp, punctuation) are merged.
3510(k) clearances (0 in 12 months)
10recalls (0 in 12 months)
10recalls that name a 510(k)
Product codes
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Jul 30, 2009 | K092086 | AMERIGEL WOUND DRESSING PLUS 1/2 OZ. (15G TUBE), MODEL A2025; 1 OZ. (30G TUBE), MODEL A2026; 3 OZ (90G TUBE),MODEL A2027 Amerx Health Care Corp. | SEJ |
| Aug 12, 1997 | K971918 | AMERIGEL OINTMENT SATURATED WOUND DRESSING Amerx Health Care Corp. | MGQ |
| Apr 14, 1997 | K970133 | AMERIGEL OINTMENT Amerx Health Care Corp. | MGQ |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| May 20, 2016 | Amerx Health Care Corp. Amerigel Hydrogel Wound Dressing Advanced Formula for wound management 1 oz. Terminated |
KMJ | K970133 |
| Jun 12, 2015 | Amerx Health Care Corp. Amerigel Hydrogel Gauze Dressing 2 x 2, A5002.
Wound Management. Terminated |
MGQ | K970133 K971918 |
| Dec 4, 2014 | Amerx Health Care Corp. Amerigel Saturated Gauze Dressing
Wound management Terminated |
MGQ | K971918 |
| Dec 4, 2014 | Amerx Health Care Corp. Amerigel Daily Dressing Packets
Wound management Terminated |
MGQ | K971918 |
| Dec 4, 2014 | Amerx Health Care Corp. Amerigel Post-op Surgical Kits
Wound management Terminated |
MGQ | K971918 |
| Dec 4, 2014 | Amerx Health Care Corp. Amerigel Hydrogel Wound Dressing
Wound management Terminated |
MGQ | K971918 |
| Sep 12, 2014 | Amerx Health Care Corp. Amerigel Daily Dressing Advanced 3-in-1 Hydrogel; 30 single used foil packets 1g. each; CAT # A2003.
Wound management. Terminated |
MGQ | K971918 |
| Sep 12, 2014 | Amerx Health Care Corp. Amerigel Post-Op Surgical Kits . Kit includes: Amerigel Wound Dressing, Amerigel Wound Wash, 22x2 Gauze Pads, and 1x3 Fabric Bandages
CAT # A2002.
Wound management. Terminated |
MGQ | K971918 |
| Sep 12, 2014 | Amerx Health Care Corp. Amerigel Hydrogel Saturated Gauze Dressing; 10 Individually Packaged pads size 2x2 4 Ply Pads; CAT # A5002.
Wound management. Terminated |
MGQ | K971918 |
| Sep 12, 2014 | Amerx Health Care Corp. Amerigel Wound Dressing Maximum Strength CAT# A2001.
Wound management. Terminated |
MGQ | K971918 |