Data / Medical devices / United States / SYNOVIS LIFE TECHNOLOGIES, INC. (A Subsidiary of Baxter International Inc.)
SYNOVIS LIFE TECHNOLOGIES, INC. (A Subsidiary of Baxter International Inc.): FDA-registered device maker in Saint Paul, MN, United States, 16 510(k) clearances
SYNOVIS LIFE TECHNOLOGIES, INC. (A Subsidiary of Baxter International Inc.) is registered with the FDA (registration 2183620) in Saint Paul, MN, United States. It lists 10 device types. The FDA files 16 510(k) clearances under its listings, the newest dated April 7, 2023. 9 recall events name it as the recalling firm (1 Class I). Registered through 2026. FDA data exported November 3, 2026.
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- FDA registration number
- 2183620
- Address
- 2575 University Ave W, Saint Paul, MN, United States, 55114
- Owner or operator
- BAXTER HEALTHCARE CORPORATION (1417572)
- Roles
- Manufacturer
- First device listed
- March 13, 2014
- Registered through
- 2026
- Brand names listed
- Dura-Guard-Dural Repair Patch, Flo-Rester, Flo-Rester Vessel Sizer, Flo-Thru, GEM Biover Clamps, Irrigating (Non-Dental) Syringe - Ear Wash System and accessories, PERI-GUARD Repair Patch, Supple PERI-GUARD Repair Patch, PERI-GUARD and SUPPLE PERI-GUARD and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Clamp, Vascular | DXC | 2 | Manufacturer | accessdata.fda.gov |
| Dilator, Vessel, Surgical | DWP | 2 | Manufacturer | accessdata.fda.gov |
| Dura Substitute | GXQ | 2 | Manufacturer | accessdata.fda.gov |
| Intracardiac Patch Or Pledget, Biologically Derived | PSQ | 2 | Manufacturer | accessdata.fda.gov |
| Mesh, Surgical | FTM | 2 | Manufacturer | accessdata.fda.gov |
| Mesh, Surgical, Collagen, Staple Line Reinforcement | OXE | 2 | Manufacturer | accessdata.fda.gov |
| Mesh, Surgical, Collagen, Thoracic, Chest Wall Reconstruction | OXB | 2 | Manufacturer | accessdata.fda.gov |
| Mesh, Surgical, Non-Synthetic, Urogynecologic, For Apical Vaginal And Uterine Prolapse, Transabdominally Placed | PAJ | 2 | Manufacturer | accessdata.fda.gov |
| Patch, Pledget And Intracardiac, Petp, Ptfe, Polypropylene | DXZ | 2 | Manufacturer | accessdata.fda.gov |
| Syringe, Irrigating (Non Dental) | KYZ | 1 | Manufacturer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| April 7, 2023 | K223052 | Peri-Guard and Supple Peri-Guard | FTM | Substantially Equivalent | Synovis Life Technologies, Inc. | accessdata.fda.gov |
| October 19, 2022 | K221032 | Vascu-Guard Vascular Repair Patch | PSQ | Substantially Equivalent | Synovis Life Technologies, Inc. | accessdata.fda.gov |
| October 19, 2022 | K221029 | PERI-GUARD Repair Patch, SUPPLE PERI-GUARD Repair Patch | PSQ | Substantially Equivalent | Synovis Life Technologies, Inc. | accessdata.fda.gov |
| September 14, 2022 | K221843 | GEM Biover Microvascular Clamps | DXC | Substantially Equivalent | Synovis Micro Companies Alliance, Inc. | accessdata.fda.gov |
| October 27, 2021 | K213125 | PERI-STRIPS Dry Staple Line Reinforcement with VERITAS Collagen Matrix with SECURE GRIP Technology | FTM | Substantially Equivalent | Synovis Life Technologies. Inc. (A Subsidiary of Baxter | accessdata.fda.gov |
| December 17, 2019 | K192615 | Peri-Strips Dry with Veritas Collagen Matrix with Secure Grip Technology (PSDV-SG) | FTM | Substantially Equivalent | Synovis Life Technologies, Inc. (Baxter International Inc.) | accessdata.fda.gov |
| April 24, 2013 | K130896 | VASCULAR PROBE, VASCULAR PROBE ES | DWP | Substantially Equivalent | Synovis Life Technologies, Inc. | accessdata.fda.gov |
| November 26, 2008 | K083039 | VERITAS COLLAGEN MATRIX (DRY) | FTM | Substantially Equivalent | Synovis Surgical Innovations | accessdata.fda.gov |
| December 6, 2006 | K062915 | VERITAS COLLAGEN MATRIX | FTM | Substantially Equivalent | Synovis Surgical Innovations | accessdata.fda.gov |
| October 27, 2004 | K041669 | VERITAS DRY COLLAGEN MATRIX, VERITAS DRY OR VERITAS PSD | FTM | Substantially Equivalent | Synovis Surgical Innovations | accessdata.fda.gov |
| November 12, 1998 | K983602 | CV PERI-GUARD AND VASCU-GUARD | DXZ | Substantially Equivalent | Bio-Vascular, Inc. | accessdata.fda.gov |
| October 9, 1998 | K983162 | PERI-GUARD, CV PERI-GUARD, OCU-GUARD, SUPPLE PERI-GUARD, PERI-STRIPS - SLEEVE, PERI-STRIPS-STRIPS, PERI-STRIPS DRY, VASC | FTM | Substantially Equivalent | Bio-Vascular, Inc. | accessdata.fda.gov |
| August 4, 1998 | K981624 | FLO-THRU | DXC | Substantially Equivalent | Bio-Vascular, Inc. | accessdata.fda.gov |
| July 30, 1998 | K982282 | DURA-GUARD - DURAL REPAIR PATCH | GXQ | Substantially Equivalent | Bio-Vascular, Inc. | accessdata.fda.gov |
| February 7, 1991 | K905159 | FLO-RESTER(R) VESSEL SIZER | DWP | Substantially Equivalent | Bio-Vascular, Inc. | accessdata.fda.gov |
| November 30, 1988 | K883696 | FLO-RESTER | DXC | Substantially Equivalent | Bio-Vascular, Inc. | accessdata.fda.gov |
Recalls
Recall events where this establishment is the recalling firm, matched on its FEI.
| Initiated | Event | Class | Status | Product | Reason | Source |
|---|---|---|---|---|---|---|
| May 2, 2015 | 71191 | Class I | Terminated | Synovis VASCU-GUARD Peripheral Vascular Patch in the following sizes and product codes: 1x6cm, product code 1504026, 0.8x8cm, product code 1504028, 1x10cm, product code 1504030, and 2x9cm, product code 1504032. VASCU-GUA | Baxter healthcare is recalling specific product codes of Vascu-Guard Peripheral Vascular Patch due to complaints received for difficulty in distinguishing the smooth from rough surface. | accessdata.fda.gov |
| October 28, 2013 | 66763 | Class II | Terminated | Vascu Guard, Peripheral Vascular Patch with Apex Processing. For use in peripheral vascular reconstruction. Product Code: VG0106N VG0106N VG0106N VG0106N VG0106N VG0106N VG0106N VG0106N VG0106N VG0106N VG0106N VG0106N VG | Synovis, a subsidiary of Baxter International Inc., is recalling certain shipments of VASCUGUARD and DURA-GUARD because Synovis, a subsidiary of Baxter International Inc., is recalling certain shipments of VASCUGUARD and DURA-GUARD because the shipping configurations in which the 6 fluid ounce units containing a specific revision of the Instructions for Use | accessdata.fda.gov |
| October 26, 2011 | 60328 | Not yet classified | Terminated | Peri-Strips Dry with Veritas Collagen Matrix Staple Line Reinforcement (PSDV), sterile EO, Rx Only, Synovis Surgical Innovations, A Division of Synovis Life Technologies, Inc, 2575 University Ave W., St Paul, MN 55114-10 | Synovis Surgical Innovations is voluntarily recalling one lot of Peri-Strips Dry with Veritas Collagen Matrix Staple Line Reinforcement (PSD-V) product because some of the devices were mislabeled. | accessdata.fda.gov |
| June 30, 2010 | 56327 | Not yet classified | Terminated | PSD Gel that's provided with Peri-Strips Dry Staple Line Reinforcement with Apex Processing (PSD) and Peri-Strips Dry with Veritas Collagen Matrix Staple Line Reinforcement (PSD-V) products. Sterile, Rx only, Synovis Sur | Synovis Surgical Innovations is voluntarily recalling PSD Gel that's provided with Peri-Strips Dry Staple Line Reinforcement with Apex Processing (PSD) and Peri-Strips Dry with Veritas Collagen Matrix Staple line Reinforcement (PSD-V) products. Internal investigation have shown there is a potential for small defects in the PSD gel tube pouch which may compro | accessdata.fda.gov |
| June 19, 2007 | 38261 | Not yet classified | Terminated | Allez Medical Applications, Inc. 4Closure Surgical Fascia Closure System, Catalog ref. 4-10GPS. Sterile, One Time Use, Contents 4 sets 1- suture passer instrument, 1-guide rod, 10 mm, 250 mm long. Distributed by Aliez Me | There is a potential for the pouch to become damaged during shipping, compromising the sterility of the device inside. | accessdata.fda.gov |
| March 16, 2007 | 37671 | Not yet classified | Terminated | Synovis Peri-Strips Dry with Veritas Collagen Matrix Circular Staple Line Reinforcement,( PSD 21-E-V), 21mm, Ethicon Circular stapler. Each package contains the following components: Cartridge and anvil assemblies, Cartr | Package Integrity/Sterility Compromised: The foil pouch in the Peri-Strips Dry with Veritas Collagen Matrix Circular Staple Line Reinforcement has a potential for minute defects which may compromise the sterility of the outside of the tray in which the device is packaged. | accessdata.fda.gov |
| November 1, 2005 | 34052 | Not yet classified | Terminated | Peri-Strips Dry with Veritas Collagen Matrix Circular Staple Line Reinforcement. Do not reuse. Ethylene Oxide Sterilized. Made in the U.S.A. Synovis Surgical Innovations A division of Synovis Life Technologies, Inc., 257 | The Peri-Strips Dry with Veritas Collagen Matrix Staple Line Reinforcement devices involved have a small chance that a seal on the outer pouch may not be completely reliable. | accessdata.fda.gov |
| May 23, 2005 | 32264 | Not yet classified | Terminated | Peri-Strips Dry with Veritas Collagen Matrix Staple Line Reinforcement (PSD-V), 4506 ETS-V. PSD-V is an implantable surgical mesh comprised of non-crosslinked bovine pericardium in a dehydrated form. Do not reuse. Consul | Device is contained in 2 pouches. The outer pouch's seal may be compromised; this may render the exterior of the interior pouch non-sterile. | accessdata.fda.gov |
| December 11, 2002 | 25226 | Not yet classified | Terminated | Surgical Mesh | A gap in the exterior seal may lead to sterility concerns with the interior pouch. | accessdata.fda.gov |
Compare with other makers
- All makers of Dilator, Vessel, Surgical
- All makers of Mesh, Surgical
- All makers of Mesh, Surgical, Non-Synthetic, Urogynecologic, For Apical Vaginal And Uterine Prolapse, Transabdominally Placed
- All makers of Patch, Pledget And Intracardiac, Petp, Ptfe, Polypropylene
Updated April 7, 2023. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.