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Sign in to claim this brandCONCERT MEDICAL, LLC
US
Last updated May 23, 2026
What CONCERT MEDICAL, LLC makes
Concert Medical produces single-use cardiac and peripheral vascular guidewires, including extension wires for coronary arteries, as well as medication delivery systems for pain management. Their portfolio includes the Galeo series (HYDRO and Pro variants) for vascular access and the S-Wire Guidewire System for interventional procedures. They also manufacture the Hands Free Syringe for medication administration.
The company’s devices are classified as Class II under FDA regulations and are authorised via 510(k) clearances and the FDA’s Unique Device Identification (UDI) system. Their products are listed in the US market.
Written from this company's registered devices by an AI model, and not verified by a human reviewer.
Frequently asked questions
What types of medical devices does Concert Medical, LLC manufacture?
Concert Medical, LLC specializes in single-use medical devices primarily for cardiovascular and pain management applications. Their portfolio includes cardiac and peripheral vascular guidewires, such as the Galeo series (including Galeo HYDRO and Galeo Pro variants) and the S-Wire Guidewire System, which are designed for vascular access and interventional procedures. Additionally, they produce the Hands Free Syringe, a medication delivery system for pain management.
Where is Concert Medical, LLC based, and where are their devices available?
Concert Medical, LLC is based in the United States. Their devices are authorized for use in the US market, where they are listed under the FDA’s regulatory systems, including the 510(k) clearance process and the Unique Device Identification (UDI) system.
How are Concert Medical, LLC’s devices classified under FDA regulations?
Concert Medical, LLC’s devices are classified as Class II under FDA regulations. This classification applies to moderate-risk medical devices that require special controls to ensure their safety and effectiveness, such as guidewires and medication delivery systems.
Which regulatory registries or databases list Concert Medical, LLC’s devices?
Concert Medical, LLC’s devices are listed in the FDA’s 510(k) clearance registry and the FDA’s Unique Device Identification (UDI) system. These registries track devices that have undergone the necessary authorization processes to ensure compliance with US regulatory requirements.
AI-generated from registry data and not verified by a human reviewer.
Information
- Country
- US
- Address
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- Website
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- Phone
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- PRRC Contact
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- EUDAMED SRN
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- FDA FEI Number
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- DUNS Number
- 189689800
Catalogue (30)
| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Galeo HYDRO | HF | FDA UDI | Class II | Active |
| Galeo Pro | F J | FDA UDI | Class II | Active |
| Galeo Pro | ES-F | FDA UDI | Class II | Active |
| Galeo | M | FDA UDI | Class II | Active |
| Hands Free Syringe | HFS-HOU | FDA UDI | Class II | Active |
| S-Wire Guidewire System | 511980-001 | FDA UDI | Class II | Active |
| Conductor | Very Floppy | FDA UDI | Class II | Active |
| Conductor | Floppy | FDA UDI | Class II | Active |
| Galeo Pro | ES-F J | FDA UDI | Class II | Active |
| Conductor | EX | FDA UDI | Class II | Active |
| Galeo HYDRO | F | FDA UDI | Class II | Active |
| Galeo Pro | M J | FDA UDI | Class II | Active |
| Galeo | HF | FDA UDI | Class II | Active |
| Conductor | Medium | FDA UDI | Class II | Active |
| Galeo Pro | M | FDA UDI | Class II | Active |
| Galeo Pro | HF | FDA UDI | Class II | Active |
| Galeo HYDRO | ES-F | FDA UDI | Class II | Active |
| Galeo | F | FDA UDI | Class II | Active |
| Galeo Pro | 300 CM | FDA UDI | Class II | Active |
| Hands Free Syringe | HFS-PDL | FDA UDI | Class II | Active |
| Conductor | Extra Support | FDA UDI | Class II | Active |
| Galeo Pro | F | FDA UDI | Class II | Active |
| Galeo | ES-F | FDA UDI | Class II | Active |
| Galeo Pro | HF J | FDA UDI | Class II | Active |
| Hands Free Syringe | HFS-SYR | FDA UDI | Class II | Active |
| Galeo EW | EW | FDA UDI | Class II | Active |
| Galeo HYDRO | M | FDA UDI | Class II | Active |
| S-Wire Guidewire System | K153397 | FDA 510(k) | Class II | Active |
| Conductor Coronary Guidewire | K090193 | FDA 510(k) | Class II | Active |
| Concert Medical Hands-Free Syringe (HFS) | K153599 | FDA 510(k) | Class II | Active |
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