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Sign in to claim this brandDallen Medical, Inc.
US
Last updated May 27, 2026
What Dallen Medical, Inc. makes
Dallen Medical, Inc. manufactures surgical staple loading units designed for non-cutting applications, primarily used in minimally invasive procedures. Their portfolio includes variants of the Compressyn Staple, which are intended for tissue approximation and closure in surgical settings.
The company’s devices are classified as Class II under FDA regulations and are authorised through the 510(k) and UDI pathways. These products are listed in the FDA’s regulatory databases, and the manufacturer operates from the United States.
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 Dallen Medical, Inc. manufacture?
Dallen Medical, Inc. specializes in surgical staple loading units designed for non-cutting applications. These devices are primarily used in minimally invasive surgeries to approximate and close tissue, ensuring secure fastening without cutting through it. Their portfolio includes multiple variants of the Compressyn Staple, which are tailored for specific surgical needs.
Where is Dallen Medical, Inc. based, and how does that affect its regulatory standing?
Dallen Medical, Inc. is headquartered in the United States. Since the company operates within the U.S., its devices are subject to FDA regulations. The FDA’s jurisdiction ensures that these products must meet specific safety and performance standards before they can be authorised for market distribution.
Which regulatory registries or databases list Dallen Medical, Inc.’s devices?
Dallen Medical, Inc.’s devices are listed in the FDA’s regulatory databases under the 510(k) and UDI (Unique Device Identification) pathways. These registries confirm the authorised status of their products, including the Compressyn Staple variants, and provide transparency on compliance with FDA requirements.
How are Dallen Medical, Inc.’s devices classified under FDA regulations?
Dallen Medical, Inc.’s devices fall under Class II classification according to FDA regulations. This classification is typically assigned to devices that pose moderate risk and require special controls beyond general controls to ensure safety and effectiveness. The 510(k) pathway is commonly used for Class II devices to demonstrate substantial equivalence to a legally marketed predicate.
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
- 010690010
Catalogue (39)
| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Compressyn Staple | PEZ-191512 | FDA UDI | N/A | Active |
| Compressyn Staple | PEZ-191518 | FDA UDI | N/A | Active |
| Compressyn Staple | PEZ-131310 | FDA UDI | N/A | Active |
| Compressyn Staple | PEZ-130907 | FDA UDI | N/A | Active |
| Compressyn Staple | PEZ-242522 | FDA UDI | N/A | Active |
| Compressyn Staple | PEZ-243030 | FDA UDI | N/A | Active |
| Compressyn Staple | PEZ-192020 | FDA UDI | N/A | Active |
| Compressyn Staple | PEZ-131512 | FDA UDI | N/A | Active |
| Compressyn Staple | PEZ-130907 | FDA UDI | N/A | Active |
| Compressyn Staple | PEZ-191818 | FDA UDI | N/A | Active |
| Compressyn Staple | PEZ-131310 | FDA UDI | N/A | Active |
| Compressyn Staple | PEZ-131110 | FDA UDI | N/A | Active |
| Compressyn Staple | PEZ-191512 | FDA UDI | N/A | Active |
| Compressyn Staple | PEZ-131110 | FDA UDI | N/A | Active |
| Compressyn Staple | PEZ-131117 | FDA UDI | N/A | Active |
| Compressyn Staple | PEZ-131119 | FDA UDI | N/A | Active |
| Compressyn Staple | PEZ-242020 | FDA UDI | N/A | Active |
| Compressyn Staple | PEZ-131115 | FDA UDI | N/A | Active |
| Compressyn Staple | PEZ-191818 | FDA UDI | N/A | Active |
| Compressyn Staple | PEZ-191518 | FDA UDI | N/A | Active |
| Compressyn Staple | PEZ-242522 | FDA UDI | N/A | Active |
| Compressyn Staple | PEZ-131512 | FDA UDI | N/A | Active |
| Compressyn Staple | PEZ-131117 | FDA UDI | N/A | Active |
| Compressyn Staple | PEZ-131115 | FDA UDI | N/A | Active |
| Compressyn Staple | PEZ-131119 | FDA UDI | N/A | Active |
| Compressyn Staple | PEZ-192020 | FDA UDI | N/A | Active |
| Compressyn Staple | PEZ-242020 | FDA UDI | N/A | Active |
| Compressyn Staple | PEZ-243030 | FDA UDI | N/A | Active |
| Compressyn Band | K101484 | FDA 510(k) | Class II | Active |
| Tensyn Plug | K150359 | FDA 510(k) | Class II | Active |
| Compressyn Band | K130431 | FDA 510(k) | Class II | Active |
| Compressyn™ Staple | K171473 | FDA 510(k) | Class II | Active |
| Compressyn Staple | K140358 | FDA 510(k) | Class II | Active |
| Compressyn Staple | K122871 | FDA 510(k) | Class II | Active |
| Tensyn Band | K131850 | FDA 510(k) | Class II | Active |
| Tensyn Plug | K143092 | FDA 510(k) | Class II | Active |
| Compressyn Staple | K132875 | FDA 510(k) | Class II | Active |
| Tensyn Band, Tensyn Fracture Plates | K141264 | FDA 510(k) | Class II | Active |
| Tensyn Band | K133858 | FDA 510(k) | Class II | Active |
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