FDA Registration
Active
🇺🇸 United States
SYNOVIS LIFE TECHNOLOGIES, INC. (A Subsidiary of Baxter International Inc.)
Reg #: 2183620
·
FEI: 2183620
·
Expires 2026
Products
10
Proprietary Names
17
Establishment Types
1
Classifications
10
Registration Details
- Registration Name
- SYNOVIS LIFE TECHNOLOGIES, INC. (A Subsidiary of Baxter International Inc.)
- Registration Number
- 2183620
- FEI Number
- 2183620
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- 2575 University Ave W
- City
- Saint Paul
- State
- MN
- ZIP
- 55114
- Country
- US
Regulatory Submissions
- 510(k) Number
- K221843
Owner / Operator
- Firm Name
- BAXTER HEALTHCARE CORPORATION
- Operator Number
- 1417572
- Address
- One Baxter Parkway
- City
- Deerfield
- State
- IL
- Postal Code
- 60015
- Country
- US
- Correspondent
- Maha Nolasco
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Clamp, Vascular | DXC | Class 2 | Cardiovascular | No | 2023-12-05 |
| Mesh, Surgical | FTM | Class 2 | General, Plastic Surgery | No | 2015-01-22 |
| Intracardiac Patch Or Pledget, Biologically Derived | PSQ | Class 2 | Cardiovascular | No | 2022-11-11 |
| Dilator, Vessel, Surgical | DWP | Class 2 | Cardiovascular | No | 2015-01-22 |
| Mesh, Surgical, Non-Synthetic, Urogynecologic, For Apical Vaginal And Uterine Prolapse, Transabdominally Placed | PAJ | Class 2 | General, Plastic Surgery | No | 2015-01-22 |
| Mesh, Surgical, Collagen, Thoracic, Chest Wall Reconstruction | OXB | Class 2 | General, Plastic Surgery | No | 2015-01-22 |
| Mesh, Surgical, Collagen, Staple Line Reinforcement | OXE | Class 2 | General, Plastic Surgery | No | 2015-01-22 |
| Patch, Pledget And Intracardiac, Petp, Ptfe, Polypropylene | DXZ | Class 2 | Cardiovascular | No | 2015-01-22 |
| Dura Substitute | GXQ | Class 2 | Neurology | No | 2015-01-22 |
| Syringe, Irrigating (Non Dental) | KYZ | Class 1 | General Hospital | No | 2014-03-13 |
Proprietary Names
GEM Biover Clamps
Peri-Strips Dry with Veritas
Flo-Thru
Vascu-Guard Vascular Repair Patch
Vascular Probe
Veritas Collagen Matrix
Flo-Rester
Vascu-Guard
Peri-Guard, Supple Peri-Guard
Flo-Rester Vessel Sizer
PERI-GUARD Repair Patch, Supple PERI-GUARD Repair Patch
Peri-Strips Dry with Veritas Collagen Matrix with Secure Grip Techonology (PSDV-SG)
Dura-Guard-Dural Repair Patch
Recothrom
Irrigating (Non-Dental) Syringe - Ear Wash System and accessories
PERI-GUARD and SUPPLE PERI-GUARD
PERI-STRIPS Dry Staple Line Reinforcement with VERITAS Collagen Matrix with SECURE GRIP Technology
Establishment Types
Manufacture Medical Device