Amerx Health Care Corp.
Clearwater, FL, US
Amerx Health Care Corp. appears in FDA device records in Clearwater, FL. FDA records list 3 510(k) clearances between and , no PMA records and no registered establishments. As of , FDA records show 10 recalls for this company.
FDA records held for this company
510(k) clearance history
FDA records hold 3 510(k) clearances for Amerx Health Care Corp. between 1997 and 2009. The busiest year on record is 1997, with 2. The most recent is 2009, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1997 | 2 |
| 2009 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K092086 | AMERIGEL WOUND DRESSING PLUS 1/2 OZ. (15G TUBE), MODEL A2025; 1 OZ. (30G TUBE), MODEL A2026; 3 OZ (90G TUBE),MODEL A2027 | SEJ | Substantially Equivalent | |
| K971918 | AMERIGEL OINTMENT SATURATED WOUND DRESSING | MGQ | Substantially Equivalent | |
| K970133 | AMERIGEL OINTMENT | MGQ | Substantially Equivalent for Some Indications |
Registered establishments
No FDA establishment registrations recorded against this company.
FDA product codes
Recall records
| Recall | Product | Reason | Classification | Initiated | Status |
|---|---|---|---|---|---|
| Z-2249-2016 | Amerigel Hydrogel Wound Dressing Advanced Formula for wound management 1 oz. | Product did not meet specifications for Zinc Acetate (OOS). | Class II | Terminated | |
| Z-1797-2015 | Amerigel Hydrogel Gauze Dressing 2 x 2, A5002. Wound Management. | Nonapproved labeling claims (Sterile) | Class II | Terminated | |
| Z-0500-2015 | Amerigel Saturated Gauze Dressing Wound management | Formulation deviation | Class II | Terminated | |
| Z-0499-2015 | Amerigel Daily Dressing Packets Wound management | Formulation deviation | Class II | Terminated | |
| Z-0498-2015 | Amerigel Post-op Surgical Kits Wound management | Formulation deviation | Class II | Terminated | |
| Z-0497-2015 | Amerigel Hydrogel Wound Dressing Wound management | Formulation deviation | Class II | Terminated | |
| Z-2641-2014 | Amerigel Daily Dressing Advanced 3-in-1 Hydrogel; 30 single used foil packets 1g. each; CAT # A2003. Wound management. | Not approved labeling claims (antimicrobial and autolytic debridement) | Class II | Terminated | |
| Z-2640-2014 | Amerigel Post-Op Surgical Kits . Kit includes: Amerigel Wound Dressing, Amerigel Wound Wash, 22x2 Gauze Pads, and 1x3 Fabric Bandages CAT # A2002. Wound management. | Not approved labeling claims (antimicrobial and autolytic debridement) | Class II | Terminated | |
| Z-2639-2014 | Amerigel Hydrogel Saturated Gauze Dressing; 10 Individually Packaged pads size 2x2 4 Ply Pads; CAT # A5002. Wound management. | Not approved labeling claims (antimicrobial and autolytic debridement) | Class II | Terminated | |
| Z-2638-2014 | Amerigel Wound Dressing Maximum Strength CAT# A2001. Wound management. | Not approved labeling claims (antimicrobial and autolytic debridement) | Class II | Terminated |
Verification record
There is no verification record for this company. Most companies on this site have none: a record exists only where a company asked to be verified and MDM ran the checks, so the absence of one says nothing about the company.
Where there is a record, this is where it appears: what was checked, when it was checked, and the current status. An MDM Verified badge on another website links to a verify address on this domain that resolves to this section. A badge that does not resolve here is not ours.
MDM coverage
MDM coverage of this company lists here, newest first. Submit news.
Is this your company?
This page is built from public FDA records. Company pages are free and factual, and stay free whether or not anyone claims them. Membership never changes editorial coverage or vetting outcomes.
Claiming lets Amerx Health Care Corp. edit what it says about itself and list the categories it works in. It grants no badge: claiming is not verification.
Data as of , FDA export datePage updated Source: openFDA, public domain