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Sign in to claim this brandSYNOVIS LIFE TECHNOLOGIES, INC.
US
Last updated May 27, 2026
What SYNOVIS LIFE TECHNOLOGIES, INC. makes
The company manufactures bioabsorbable and collagen-based surgical products, including staple line-reinforcement strips and gels for tissue reinforcement, as well as animal-derived cardiovascular patches and dura mater grafts. It also produces intravascular devices such as single-use probes, anastomosis occluders, and surgical shunts for vascular applications, alongside extra-gynaecological surgical meshes for specific medical procedures.
These products are classified under FDA Class II devices and are authorised through the 510(k) and De Novo pathways. The company’s devices are listed in the FDA’s regulatory databases, including the 510(k) Premarket Notification and the Unique Device Identifier (UDI) system, and the company is based in 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 Synovis Life Technologies, Inc. manufacture?
Synovis Life Technologies, Inc. specializes in bioabsorbable and collagen-based surgical products. Their portfolio includes staple line-reinforcement strips and gels designed to strengthen tissue, animal-derived cardiovascular patches and dura mater grafts for reconstructive procedures, and intravascular devices like single-use probes, anastomosis occluders, and surgical shunts. They also produce extra-gynaecological surgical meshes made from collagen, which are intended for specific surgical applications.
Where is Synovis Life Technologies, Inc. based?
Synovis Life Technologies, Inc. is headquartered in the United States. The company’s location is relevant for understanding its regulatory framework, as it operates under U.S. medical device regulations, including those enforced by the FDA.
How are Synovis Life Technologies, Inc.’s devices classified by the FDA?
Synovis Life Technologies, Inc.’s devices are classified under FDA Class II. This classification typically applies to devices that pose moderate risk and require special controls to ensure safety and effectiveness, such as performance standards or post-market surveillance. Class II devices are authorised through pathways like the 510(k) Premarket Notification or the De Novo process.
Which regulatory registries or databases list Synovis Life Technologies, Inc.’s devices?
Synovis Life Technologies, Inc.’s devices are listed in the FDA’s regulatory databases, specifically the 510(k) Premarket Notification database and the Unique Device Identifier (UDI) system. These registries help track and monitor devices authorised for commercial distribution in the U.S., ensuring transparency and compliance with regulatory requirements.
Why are Synovis Life Technologies, Inc.’s devices authorised through the 510(k) and De Novo pathways?
The 510(k) pathway is used for devices that are substantially equivalent to legally marketed predicates, demonstrating they meet the same safety and performance standards. The De Novo pathway is reserved for low-to-moderate-risk devices with no legally marketed predicate, allowing the FDA to classify them as Class II after reviewing their safety and effectiveness data. Synovis’s devices, such as staple line-reinforcement strips and intravascular occluders, fall under these pathways due to their specific risk profiles and intended uses.
AI-generated from registry data and not verified by a human reviewer.
Information
- Country
- US
- Address
- —
- Website
- baxter.com
- —
- —
- [email protected]
- Phone
- +1(800)933-0303
- PRRC Contact
- —
- EUDAMED SRN
- —
- FDA FEI Number
- —
- DUNS Number
- 017415781
Catalogue (163)
Page 4 of 4| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| DURA-GUARD Dural Repair Patch | DG1016SN | FDA UDI | Class II | Active |
| Flo-Rester® Disposable Internal Vessel Occluder | 50100 | FDA UDI | Class II | Active |
| Flo-Rester® Disposable Internal Vessel Occluder | 50450 | FDA UDI | Class II | Active |
| Flo-Thru Intraluminal Shunt® | FT-12150 | FDA UDI | Class II | Active |
| GEM Flow COUPLER Device and System | K143589 | FDA 510(k) | Class II | Active |
| VASCU-GUARD Peripheral Vascular Patch | K142461 | FDA 510(k) | Class II | Active |
| GEM Flow COUPLER Device and System | K142309 | FDA 510(k) | Class II | Active |
| Peri-Guard and Supple Peri-Guard | K223052 | FDA 510(k) | Class II | Active |
| Vascu-Guard Vascular Repair Patch | K221032 | FDA 510(k) | Class II | Active |
| PERI-GUARD Repair Patch & SUPPLE PERI-GUARD Repair Patch | K142447 | FDA 510(k) | Class II | Active |
| Vascular Probe, Vascular Probe Es | K130896 | FDA 510(k) | Class II | Active |
| Gem Flow Coupler Device And System | K132727 | FDA 510(k) | Class II | Active |
| PERI-GUARD Repair Patch, SUPPLE PERI-GUARD Repair Patch | K221029 | FDA 510(k) | Class II | Active |
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