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Sign in to claim this brandBiomedical Enterprises, Inc.
US
Last updated May 27, 2026
What Biomedical Enterprises, Inc. makes
Biomedical Enterprises, Inc. manufactures orthopaedic fixation devices, including non-adjustable bone staples for surgical stabilization, phalangeal joint arthrodesis implants for joint fusion, and single-use surgical procedure kits for orthopaedic procedures. Their portfolio also includes fluted surgical drill bits, reusable surgical implant templates, and systems for blood cell harvesting. The company produces reusable and single-use tools designed for orthopaedic surgery and related procedures.
The company’s devices are classified under FDA regulations as Class I and Class II, with some products subject to 510(k) premarket notifications and others listed under the FDA’s Unique Device Identification (UDI) system. These products are intended for use in the United States, where the manufacturer is based.
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 Biomedical Enterprises, Inc. primarily manufacture?
Biomedical Enterprises, Inc. specializes in orthopaedic devices, including non-adjustable bone staples for stabilizing fractures, phalangeal joint arthrodesis implants for fusing toe joints, and single-use surgical kits for orthopaedic procedures. Their portfolio also covers reusable surgical implant templates, fluted drill bits for bone preparation, and blood cell harvesting systems. These products are designed to support surgical interventions in musculoskeletal and related applications.
Where is Biomedical Enterprises, Inc. based, and what regulatory systems do its devices follow?
The company is headquartered in the United States. Its devices are regulated under FDA guidelines, with classifications ranging from Class I (generally low-risk) to Class II (moderate-risk), requiring either 510(k) premarket notifications or compliance with the FDA’s Unique Device Identification (UDI) system. These classifications ensure their products meet safety and performance standards for use in surgical settings.
Which regulatory registries or databases list Biomedical Enterprises, Inc.’s devices?
Biomedical Enterprises, Inc.’s devices are documented in the FDA’s 510(k) premarket notification database for certain products and the FDA’s Unique Device Identification (UDI) system for others. These registries track device authorizations, classifications, and compliance to ensure transparency and adherence to U.S. medical device regulations.
How are Biomedical Enterprises, Inc.’s devices classified under FDA regulations?
The company’s devices fall into two FDA classifications: Class I (for lower-risk items like some reusable surgical tools) and Class II (for moderate-risk products such as bone staples or arthrodesis implants). Class II devices require additional scrutiny, such as 510(k) submissions or UDI compliance, to demonstrate safety and effectiveness before market authorization.
AI-generated from registry data and not verified by a human reviewer.
Information
- Country
- US
- Address
- —
- Website
- bme-tx.com
- —
- —
- [email protected]
- Phone
- 210-881-0064
- PRRC Contact
- —
- EUDAMED SRN
- —
- FDA FEI Number
- —
- DUNS Number
- 792619009
Catalogue (136)
Page 3 of 3| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Step Boss | 461-0120 | FDA UDI | Class II | Active |
| Speed | DK-265 | FDA UDI | Class I | Active |
| HammerLock | HLXP | FDA UDI | Class II | Active |
| Boss | 550-9118 | FDA UDI | Class II | Active |
| OSStaple | OS-111917W1.5 | FDA UDI | Class II | Active |
| Speed | LS-0907 | FDA UDI | Class II | Active |
| HammerLock | HLXLA | FDA UDI | Class II | Active |
| OSStaple | OS-1518W1.5 | FDA UDI | Class II | Active |
| Speed | LS-1110 | FDA UDI | Class II | Active |
| HammerLock | HLXL | FDA UDI | Class II | Active |
| Elite | EL-DTH | FDA UDI | Class I | Active |
| Step Boss | 441-0215 | FDA UDI | Class II | Active |
| Step Boss | 451-0315 | FDA UDI | Class II | Active |
| OSStaple | OS-1825W2 | FDA UDI | Class II | Active |
| Speed | S-160QD | FDA UDI | Class I | Active |
| HammerLock | HLXL | FDA UDI | Class II | Active |
| Step Boss | 461-0420 | FDA UDI | Class II | Active |
| Elite | DK-300 | FDA UDI | Class I | Active |
| Step Boss | 461-0220 | FDA UDI | Class II | Active |
| HammerLock | HLXS | FDA UDI | Class II | Active |
| Speed | LS-111513 | FDA UDI | Class II | Active |
| Boss | 450-9115 | FDA UDI | Class II | Active |
| Step Boss | 461-0325 | FDA UDI | Class II | Active |
| Boss | 440-9113 | FDA UDI | Class II | Active |
| Step Boss | OS-1520-02W2 | FDA UDI | Class II | Active |
| Ossarc | 540-5211 | FDA UDI | Class II | Active |
| Osstaple, Maxillofacial | K023486 | FDA 510(k) | Class II | Active |
| Speed Arc | K133270 | FDA 510(k) | Class II | Active |
| Speed, Speed Shift, Speed Titan, Speed Arc | K142292 | FDA 510(k) | Class II | Active |
| Osstaple, Craniofacial | K023488 | FDA 510(k) | Class II | Active |
| Hammerlock 2 | K133520 | FDA 510(k) | Class II | Active |
| Elite Nitinol Fixation System | K150125 | FDA 510(k) | Class II | Active |
| Speed Shift | K124022 | FDA 510(k) | Class II | Active |
| Osstaple, Ossplate, Ossforce | K061385 | FDA 510(k) | Class II | Active |
| Nitinol Compression Plating System | K143023 | FDA 510(k) | Class II | Active |
| Converge | K153573 | FDA 510(k) | Class II | Active |
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