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Sign in to claim this brandGauthier Biomedical, Inc.
United States·US-MF-000015766
Last updated September 17, 2026
About
Gauthier Biomedical, Inc. is a proud manufacturer of high-quality instruments for spine, trauma, hip, shoulder, knee, ankle and small bone surgical applications.
From the manufacturer's own website. Source
Information
- Country
- United States
- Address
- 2221, Washington Street, Grafton, United States
- Website
- www.gauthierbiomedical.com
- —
- —
- [email protected]
- Phone
- +1 262 546 0010
- PRRC Contact
- Heidi Wright
- EUDAMED SRN
- US-MF-000015766
- FDA FEI Number
- 3010938185
- DUNS Number
- —
Catalogue (63)
Page 2 of 2| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Gauthier Biomedical | 5161-00-5017 | EUDAMEDFDA UDI | Class I | Active |
| Gauthier Biomedical | 5161-00-5026 | EUDAMEDFDA UDI | Class I | Active |
| Gauthier Biomedical | G851100 | EUDAMEDFDA UDI | Class I | Active |
| Gauthier Biomedical | GC101210 | EUDAMEDFDA UDI | Class I | Active |
| Gauthier Biomedical | 5161-00-5053 | EUDAMEDFDA UDI | Class I | Active |
| Gauthier Biomedical | G850000 | EUDAMEDFDA UDI | Class I | Active |
| Gauthier Biomedical | G170059 | EUDAMEDFDA UDI | Class I | Active |
| Gauthier Biomedical | 5161-00-5004 | EUDAMEDFDA UDI | Class I | Active |
| Gauthier Biomedical | G912126 | EUDAMEDFDA UDI | Class I | Active |
| Gauthier Biomedical | G911000 | EUDAMEDFDA UDI | Class I | Active |
| Gauthier Biomedical | G170402 | EUDAMEDFDA UDI | Class I | Active |
| Gauthier Biomedical | 5161-00-5001 | EUDAMEDFDA UDI | Class I | Active |
| Gauthier Biomedical | 5161-00-5048 | EUDAMEDFDA UDI | Class I | Active |
Related Companies
Authorised Representatives
- MDSS GmbH DE
Importers
Not available yet.
Notified Bodies
Not available yet.
Authorities
Not available yet.
FDA Recalls (1)
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 |
|---|---|---|---|---|
| Nov 11, 2024 | Z-0572-2025 | — | open, classified | An out of specification component may result in the device exhibiting torque output higher than the design specification. |