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Sign in to claim this brandNEOCOIL, LLC
United States·US-MF-000027128
Last updated September 17, 2026
Information
- Country
- United States
- Address
- N27 W23910A , Paul Rd, Pewaukee, United States
- Website
- neocoil.com
- —
- —
- [email protected]
- Phone
- +1 (262) 522-6124
- PRRC Contact
- Kate Gonzalez
- EUDAMED SRN
- US-MF-000027128
- FDA FEI Number
- 3006369484
- DUNS Number
- 781155176
Catalogue (108)
Page 3 of 3| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Biopsy Drape | NC088475 | EUDAMED | Class I | Active |
| GEM Flex Interface 16ch Fixed, 1.5T HD-Connector | NC022203 | EUDAMEDFDA UDI | Class I | Active |
| 3.0T AIR Open Head Anterior 16ch | NC139202 | EUDAMEDFDA UDI | Class I | Active |
| GEM Flex Pediatric Interface, 16ch, 1.5T P-Connector | NC022210 | EUDAMEDFDA UDI | Class I | Active |
| 3T Receive-Only 16ch Flex SPEEDER Medium | NC045200 | EUDAMEDFDA UDI | Class I | Active |
| Foot-Ankle Stabilizer, Flex Coils | NC074000 | EUDAMEDFDA UDI | Class I | Active |
| Guardian P2 Wireless Audio System | NC130002 | EUDAMED | Class I | Active |
| GEM Flex Coil 16-L Array, 3.0T Receive Only | NC040200 | EUDAMEDFDA UDI | Class I | Active |
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FDA Recalls (2)
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 |
|---|---|---|---|---|
| Jun 17, 2016 | Z-2312-2016 | — | terminated | There is a potential for higher than specified surface temperatures involving the 3T 16ch Flex SPEEDER Large Coil. |
| Dec 18, 2015 | Z-1027-2016 | — | terminated | Potential for higher than specified surface temperatures. Use of 3.0T GEM Flex system may result in patient warming or burns. |