SYNOVIS LIFE TECHNOLOGIES, Inc. (A Subsidiary of Baxter International Inc.)
Saint Paul, MN, US
SYNOVIS LIFE TECHNOLOGIES, INC. (A Subsidiary of Baxter International Inc.) appears in FDA device records in Saint Paul, MN. FDA records list 8 510(k) clearances between and , 7 PMA records and one registered establishment. As of , FDA records show 21 recalls for this company, and at least one establishment registration is current.
FDA records held for this company
FDA records under these names
2 namesFDA records resolved to SYNOVIS LIFE TECHNOLOGIES, Inc. (A Subsidiary of Baxter International Inc.) carry these names as well, as FDA wrote them. Each is the firm named on a registration, a 510(k), a PMA, a recall or an enforcement report that was joined to this company on a shared FDA identifier or on a matching name.
- Synovis Surgical Innovations510(k), PMA, enforcement report, recall
- Synovis Surgical Inovation Div. ofrecall
510(k) clearance history
FDA records hold 8 510(k) clearances for SYNOVIS LIFE TECHNOLOGIES, Inc. (A Subsidiary of Baxter International Inc.) between 2003 and 2013. The busiest year on record is 2004, with 4. The most recent is 2013, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 2003 | 1 |
| 2004 | 4 |
| 2006 | 1 |
| 2008 | 1 |
| 2013 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K122306 | SYNOVIS COLLAGEN MATRIX (TBD) | DXZ | Substantially Equivalent | |
| K083039 | VERITAS COLLAGEN MATRIX (DRY) | FTM | Substantially Equivalent | |
| K062915 | VERITAS COLLAGEN MATRIX | FTM | Substantially Equivalent | |
| K041669 | VERITAS DRY COLLAGEN MATRIX, VERITAS DRY OR VERITAS PSD | FTM | Substantially Equivalent | |
| K040415 | PERI-STRIPS STAPLE LINE REINFORCEMENT - SLEEVE AND STRIP CONFIGURATIONS - AND PERI-STRIPS DRY STAPLE LINE REINFORCEMENT | DXZ | Substantially Equivalent | |
| K040119 | PERI-STRIPS STAPLE LINE REINFORCEMENT-SLEEVE CONFIGURATION, PERI-STRIPS STAPLE LINE REINFORCEMENT-STRIP CONFIGURATION | FTM | Substantially Equivalent | |
| K040001 | STEERABLE STYLET | DRB | Substantially Equivalent | |
| K030879 | VERITAS COLLAGEN MATRIX | OXE | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 2183620 | 2183620 | SYNOVIS LIFE TECHNOLOGIES, INC. (A Subsidiary of Baxter International Inc.) | 2575 University Ave W, Saint Paul, MN 55114 US | 2026 |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
- DXCClamp, Vascular
- DWPDilator, Vessel, Surgical
- GXQDura Substitute
- PSQIntracardiac Patch Or Pledget, Biologically Derived
- FTMMesh, Surgical
- OXEMesh, Surgical, Collagen, Staple Line Reinforcement
- OXBMesh, Surgical, Collagen, Thoracic, Chest Wall Reconstruction
- PAJMesh, Surgical, Non-Synthetic, Urogynecologic, For Apical Vaginal And Uterine Prolapse, Transabdominally Placed
- DXZPatch, Pledget And Intracardiac, Petp, Ptfe, Polypropylene
- DRBStylet, Catheter
- KYZSyringe, Irrigating (Non Dental)
- LXATissue Graft Of 6mm And Greater
Recall records
| Recall | Product | Reason | Classification | Initiated | Status |
|---|---|---|---|---|---|
| Z-1637-2015 | 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-GUARD is packaged between two pieces of foam within a double sterile barrier pouch system. The contents of the unopened, undamaged package are sterile. VASCU-GUARD is intended for use in peripheral vascular reconstruction including the carotid, renal, iliac, femoral, profunda, and tibial blood vessels and arteriovenous access revisions. | 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. | Class I | Terminated | |
| Z-0339-2014 | Dura Guard, Dural Repair Patch with Apex Processing. For use as a dura substitute for the closure of dura mater during neurosurgery. Product Code: DG0209SN DG0209SN DG0209SN DG0209SN DG0209SN DG0209SN DG0209SN DG0209SN DG0404SN DG0404SN DG0404SN DG0404SN DG0404SN DG0404SN DG0404SN DG0404SN DG0404SN DG0404SN DG0404SN DG0404SN DG0404SN DG0404SN DG0404SN DG0608SN DG0608SN DG0608SN DG0608SN DG0608SN DG0608SN DG0608SN DG0608SN DG0608SN DG0608SN DG0608SN DG0608SN DG0608SN DG0608SN DG0608SN DG0608SN DG0608SN DG0608SN DG0608SN | 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 (IFU) shipped in a divided cell shipping | Class II | Terminated | |
| Z-0338-2014 | 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 VG0106N VG0106N VG0106N VG0106N VG0106N VG0106N VG0106N VG0106N VG0106N VG0106N VG0106N VG0106N VG0106N VG0106N VG0106N VG0106N VG0106N VG0108N VG0108N VG0108N VG0108N VG0108N VG0108N VG0108N VG0108N VG0108N VG0108N VG0108N VG0108N VG0108N VG0108N VG0108N VG0108N VG0108N VG0108N VG0108N VG0108N VG0108N VG0108N VG0108N VG0108N VG0108N VG0108N VG0108N VG0108N VG0108N VG0108N VG0108N VG0108N VG0108N VG0108N VG0108N VG0108N VG0108N VG0108N VG0108N VG0108N VG0108N VG0108N VG0108N VG0108N VG0108N VG0108N VG0108N VG0108N VG0108N VG0108N VG0108N VG0108N VG0108N VG0108N VG0108N VG0108N VG0108N VG0108N VG0108N VG0108N VG0108N VG0108N VG0108N VG0108N VG0108N VG0108N VG0108N VG0108N VG0108N VG0108N VG0108N VG0108N VG0108N VG0108N VG0108N VG0108N VG0108N VG0108N VG0108N VG0108N VG0108N VG0108N VG0108N VG0108N VG0108N VG0108N VG0108N VG0108N VG0108N VG0108N VG0108N VG0108N VG0108N VG0108N VG0108N VG0108N VG0108N VG0108N VG0108N VG0110N VG0110N VG0110N VG0110N VG0110N VG0110N VG0209N VG0209N VG0209N VG0209N VG0209N VG0209N VG0209N VG0209N VG0209N VG0209N VG0209N VG0209N VG0209N VG0209N VG0209N VG0209N VG0209N VG0209N VG0209N VG0209N VG0209N VG0209N VG0209N VG0209N VG0209N | 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 (IFU) shipped in a divided cell shipping | Class II | Terminated | |
| Z-0274-2012 | 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 55114-1024. The device is intended to be used as a staple line buttress | 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. | Terminated | ||
| Z-2447-2010 | 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 Surgical Innovations. Intended to be used as a staple line buttress. | 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 compromise the sterility of the outside of t | Terminated | ||
| Z-1085-2007 | Allez Medical Applications, Inc. 4Closure Surgical Fascia Closure System , Catalog ref. 4S. Sterile, One Time Use, Contents 4 sets 1- suture passer instrument. Distributed by Aliez Medical Applications, Inc., Santa Ana, CA 92707. Synovis over labels the "Distributed by....", For Customer Service Contact: Synovis Surgical Innovations 2575 University Ave W., St. Paul, MN 55114-1024 | There is a potential for the pouch to become damaged during shipping, compromising the sterility of the device inside. | Terminated | ||
| Z-1084-2007 | Allez Medical Applications, Inc. 4Closure Surgical Fascia Closure System , Catalog ref. 4-23DGPS . Sterile, One Time Use, Contents 4 sets 1- suture passer instrument, 1-guide rod, 23 mm, 250 mm long, dilating. Distributed by Aliez Medical Applications, Inc., Santa Ana, CA 92707. Synovis over labels the "Distributed by....", For Customer Service Contact: Synovis Surgical Innovations 2575 University Ave W., St. Paul, MN 55114-1024 | There is a potential for the pouch to become damaged during shipping, compromising the sterility of the device inside. | Terminated | ||
| Z-1083-2007 | Allez Medical Applications, Inc. 4Closure Surgical Fascia Closure System , Catalog ref. 4-23DG. Sterile, One Time Use, Contents 4 sets 1-guide rod, 23 mm, 250 mm long, dilating. Distributed by Aliez Medical Applications, Inc., Santa Ana, CA 92707. Synovis over labels the "Distributed by....", For Customer Service Contact: Synovis Surgical Innovations 2575 University Ave W., St. Paul, MN 55114-1024 | There is a potential for the pouch to become damaged during shipping, compromising the sterility of the device inside. | Terminated | ||
| Z-1082-2007 | Allez Medical Applications, Inc. 4Closure Surgical Fascia Closure System , Catalog ref. 4-15GPS . Sterile, One Time Use, Contents 4 sets 1- suture passer instrument, 1-guide rod, 15 mm, 250 mm long. Distributed by Aliez Medical Applications, Inc., Santa Ana, CA 92707. Synovis over labels the "Distributed by....", For Customer Service Contact: Synovis Surgical Innovations 2575 University Ave W., St. Paul, MN 55114-1024 | There is a potential for the pouch to become damaged during shipping, compromising the sterility of the device inside. | Terminated | ||
| Z-1081-2007 | Allez Medical Applications, Inc. 4Closure Surgical Fascia Closure System , Catalgo ref. 4-12GPS. Sterile, One Time Use, Contents 4 sets 1- suture passer instrument, 1-guide rod, 12mm, 250 mm long. Distributed by Aliez Medical Applications, Inc., Santa Ana, CA 92707. Synovis over labels the "Distributed by....", For Customer Service Contact: Synovis Surgical Innovations 2575 University Ave W., St. Paul, MN 55114-1024 | There is a potential for the pouch to become damaged during shipping, compromising the sterility of the device inside. | Terminated | ||
| Z-1080-2007 | 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 Medical Applications, Inc., Santa Ana, CA 92707. Synovis over labels the "Distributed by....", For Customer Service Contact: Synovis Surgical Innovations 2575 University Ave W., St. Paul, MN 55114-1024 | There is a potential for the pouch to become damaged during shipping, compromising the sterility of the device inside. | Terminated | ||
| Z-0965-2007 | Synovis Peri-Strips Dry with Veritas Collagen Matrix Circular Staple Line Reinforcement, (PSD 28-U-V), 28mm, US Surgical Staplers. Each package contains the following components: Cartridge and anvil assemblies, Cartridge cone, PSD Gel, & C-clip | 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. | Terminated | ||
| Z-0964-2007 | Synovis Peri-Strips Dry with Veritas Collagen Matrix Circular Staple Line Reinforcement, ( PSD 25-U-V), 25 mm, US Surgical Staplers. Each package contains the following components: Cartridge and anvil assemblies, Cartridge cone, PSD Gel, & C-clip | 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. | Terminated | ||
| Z-0963-2007 | Synovis Peri-Strips Dry with Veritas Collagen Matrix Circular Staple Line Reinforcement, ( PSD 21-U-V), 21mm, US Surgical Staplers. Each package contains the following components: Cartridge and anvil assemblies, Cartridge cone, PSD Gel, & C-clip | 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. | Terminated | ||
| Z-0962-2007 | Synovis Peri-Strips Dry with Veritas Collagen Matrix Circular Staple Line Reinforcement, ( PSD 29-E-V), 29 mm, Ethicon Circular stapler. Each package contains the following components: Cartridge and anvil assemblies, Cartridge cone, PSD Gel, & C-clip | 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. | Terminated | ||
| Z-0961-2007 | Synovis Peri-Strips Dry with Veritas Collagen Matrix Circular Staple Line Reinforcement, (PSD 25-E-V), 25mm, Ethicon Circular stapler. Each package contains the following components: Cartridge and anvil assemblies, Cartridge cone, PSD Gel, & C-clip | 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. | Terminated | ||
| Z-0960-2007 | 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, Cartridge cone, PSD Gel, & C-clip. | 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. | Terminated | ||
| Z-0764-06 | 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., 2575 University Ave. W., St. Paul, MN 55114-1024 USA. | 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. | Terminated | ||
| Z-0892-05 | Peri-Strips Dry with Veritas Collagen Matrix Staple Line Reinforcement (PSD-V), 4506 E-V. PSD-V is an implantable surgical mesh comprised of non-crosslinked bovine pericardium in a dehydrated form. Do not reuse. Consult Instructions for Use. Sterilized. Product treated with sodium hydroxide. Produt derived from USDA-inspected cattle. Made in the U.S.A. Rx Only. Synovis Surgical Innovations A Division of Synovis Life Technologies, Inc., 6575 University Ave W., St. Paul, MN 55114-1024 USA. 651 796-7300, 800.487.9627 | 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. | Terminated | ||
| Z-0891-05 | 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. Consult Instructions for Use. Sterilized. Product treated with sodium hydroxide. Produt derived from USDA-inspected cattle. Made in the U.S.A. Rx Only. Synovis Surgical Innovations A Division of Synovis Life Technologies, Inc., 6575 University Ave W., St. Paul, MN 55114-1024 USA. 651 796-7300, 800.487.9627 | 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. | Terminated | ||
| Z-0352-03 | Surgical Mesh | A gap in the exterior seal may lead to sterility concerns with the interior pouch. | Terminated |
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Data as of , FDA export datePage updated Source: openFDA, public domain