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Sign in to claim this brandBradshaw Medical Inc.
United States·US-MF-000003392
Last updated September 17, 2026
Information
- Country
- United States
- Address
- 10325 58th Place, Kenosha, United States
- Website
- www.exalta.com
- —
- —
- [email protected]
- Phone
- —
- PRRC Contact
- Tania Shammo
- EUDAMED SRN
- US-MF-000003392
- FDA FEI Number
- 3006846753
- DUNS Number
- —
Catalogue (215)
Page 5 of 5| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Bradshaw Medical Inc. | 920-0305 | FDA UDI | Class I | Active |
| Plate blade without teeth - length 80 mm | MRS-110-080 | FDA UDI | Class I | Active |
| Concentrical blade - length 80 mm | MRS-108-080 | FDA UDI | Class I | Active |
| Plate blade with teeth - length 50 mm | MRS-109-050 | FDA UDI | Class I | Active |
| Plate blade without teeth - length 120 mm | MRS-110-120 | FDA UDI | Class I | Active |
| Distraction Compression Case | MRS-103 | EUDAMEDFDA UDI | Class I | Active |
| Dilator 3 | MRS-107-3 | FDA UDI | Class I | Active |
| Left Rotative Arm | MRS-106-L | EUDAMEDFDA UDI | Class I | Active |
| Arm (Articulated Arm for Radial Clamp) | MRS-115 | FDA UDI | Class I | Active |
| Plate blade without teeth - length 60 mm | MRS-110-060 | FDA UDI | Class I | Active |
| Axial Handle, Trilobe Quick Connect, Ratcheting | No | EUDAMEDFDA UDI | Class I | Active |
| T Handle, Trilobe Quick Connect Ratcheting | No | EUDAMEDFDA UDI | Class I | Active |
| Rtch T Stealth 11 Mm | No | EUDAMEDFDA UDI | Class I | Active |
| Mini Ratcheting Handle, AO Quick Connect | No | EUDAMEDFDA UDI | Class I | Active |
| Lumbar Rod Gripper with Box Ratchet | No | EUDAMEDFDA UDI | Class I | Active |
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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 |
|---|---|---|---|---|
| Feb 2, 2015 | Z-1637-2016 | — | terminated | A component failure could cause a situation where the applied torque was significantly higher than the calibrated torque setting. |