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US
Last updated September 17, 2026
Information
- Country
- US
- Address
- 250 N Belmont Ave, INDIANAPOLIS, IN, 46222
- Website
- —
- —
- —
- —
- Phone
- —
- PRRC Contact
- —
- EUDAMED SRN
- —
- FDA FEI Number
- 1832066
- DUNS Number
- —
Catalogue (217)
Page 1 of 5| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Waffle | REV00 | FDA UDI | Class I | Active |
| Waffle | REV00 | FDA UDI | Class I | Active |
| Waffle | REV00 | FDA UDI | Class I | Active |
| Foothold | REV00 | FDA UDI | Class I | Active |
| Waffle | REV00 | FDA UDI | Class I | Active |
| Waffle | REV00 | FDA UDI | Class I | Active |
| Waffle | REV00 | FDA UDI | Class I | Active |
| Foothold | REV00 | FDA UDI | Class I | Active |
| Truvue | REV00 | FDA UDI | Class I | Active |
| Waffle | REV00 | FDA UDI | Class I | Active |
| Waffle | REV00 | FDA UDI | Class I | Active |
| Foothold | REV00 | FDA UDI | Class I | Active |
| Foothold | REV00 | FDA UDI | Class I | Active |
| ComfortTopES | REV00 | FDA UDI | Class I | Active |
| Truvue | REV00 | FDA UDI | Class I | Active |
| Waffle | REV00 | FDA UDI | Class I | Active |
| Waffle | REV00 | FDA UDI | Class I | Active |
| Truvue | REV00 | FDA UDI | Class I | Unknown |
| Foothold | REV00 | FDA UDI | Class I | Active |
| Waffle | REV00 | FDA UDI | Class I | Active |
| Bam | REV00 | FDA UDI | Class I | Active |
| Foothold | REV00 | FDA UDI | Class I | Active |
| Waffle | REV00 | FDA UDI | Class I | Active |
| Dermacare | REV00 | FDA UDI | Class I | Active |
| Truvue | REV00 | FDA UDI | Class I | Active |
| Foothold | REV00 | FDA UDI | Class I | Active |
| Foothold | REV00 | FDA UDI | Class I | Active |
| Waffle | REV00 | FDA UDI | Class I | Active |
| Bam | REV00 | FDA UDI | Class I | Active |
| Truvue | REV00 | FDA UDI | Class I | Active |
| Bam | REV00 | FDA UDI | Class I | Active |
| Waffle | REV00 | FDA UDI | Class I | Active |
| Waffle | REV00 | FDA UDI | Class I | Active |
| Foothold | REV00 | FDA UDI | Class I | Active |
| Bam | REV00 | FDA UDI | Class I | Active |
| Waffle | REV00 | FDA UDI | Class I | Active |
| Dermacare | REV00 | FDA UDI | Class I | Active |
| Truvue | REV00 | FDA UDI | Class I | Active |
| Foothold | REV00 | FDA UDI | Class I | Active |
| Dermacare | REV00 | FDA UDI | Class I | Active |
| Dermacare | REV00 | FDA UDI | Class I | Active |
| Bam | REV00 | FDA UDI | Class I | Active |
| Waffle | REV00 | FDA UDI | Class I | Active |
| Waffle | REV00 | FDA UDI | Class I | Active |
| Waffle | REV00 | FDA UDI | Class I | Active |
| Waffle | REV00 | FDA UDI | Class I | Active |
| Foothold | REV00 | FDA UDI | Class I | Active |
| Dermacare | REV00 | FDA UDI | Class I | Active |
| TruVue | REV00 | FDA UDI | Class I | Active |
| Dermacare | REV00 | FDA UDI | Class I | Active |
Related Companies
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FDA Recalls (3)
Recalls reported by this firm to the FDA. Listed at company level — FDA recall records don't identify a specific catalogue device.
| Date | Recall No. | Class | Status | Reason |
|---|---|---|---|---|
| Apr 19, 2021 | Z-1950-2021 | — | open, classified | Product contamination-a trace amount of dried bodily fluids may expose patients, health care providers to contaminates |
| Jun 9, 2020 | Z-2640-2020 | — | terminated | QC inspection observed that a portion of the lot may have been contaminated with blood. |
| Jan 19, 2020 | Z-1457-2020 | — | terminated | Due to a nonconformance of product contamination (human blood) of Econocare Plus Waffle Overlay products with the (master) lot # 932213A that may affect a subset of the lot- controlled product (# 932243A). This nonconformance has the potential to expose the end user to materials deemed to be a health risk. Firm is aware of zero instances of contamination in distributed products that have reached consignees. |