Synovis Surgical Innovations
Country not established
- Devices
- 9
- FDA recalls
- 3
At a glance
Market reach
- United States
- FDA recalls
What Synovis Surgical Innovations makes
The company manufactures collagen-based matrices and biological grafts for surgical reinforcement, including VERITAS Collagen Matrix (both hydrated and dry variants) for tissue integration and wound healing, as well as PERI-STRIPS Staple Line Reinforcement in sleeve and strip configurations to prevent dehiscence. It also produces the DARDIK Biograft, a modified human umbilical vein graft for vascular applications, and a steerable stylet for procedural guidance.
These devices are regulated under FDA pathways, with Class II products authorised via 510(k) clearance and Class III products through Premarket Approval (PMA). The company’s products are listed in the FDA’s 510(k) and PMA registries, and the manufacturer is based in the United States.
Catalogue
Veritas Collagen Matrix Ref K030879
510(k) 510(k)Synovis Collagen Matrix (Tbd) Ref K122306
510(k) 510(k)- 510(k) 510(k)
Steerable Stylet Ref K040001
510(k) 510(k)Veritas Collagen Matrix (Dry) Ref K083039
510(k) 510(k)- 510(k) 510(k)
- 510(k) 510(k)
Veritas Collagen Matrix Ref K062915
510(k) 510(k)- PMA, withdrawn PMA
FDA recalls
FDA recall records list 3 recalls initiated by Synovis Surgical Innovations, the earliest on 2013-10-28 and the most recent on 2015-05-02. By recorded status: 3 terminated. The reasons filed fall into these groups: other reasons as filed. A recall is often a precaution started by the manufacturer, and a count of records is not a verdict on a company.
2015
- 2 May 2015 Z-1637-2015 Class I Terminated 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.
2013
- 28 Oct 2013 Z-0338-2014 Class II Terminated 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
- 28 Oct 2013 Z-0339-2014 Class II Terminated 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
Frequently asked questions
How many devices does Synovis Surgical Innovations have in the registry?
The registry currently lists 9 devices for Synovis Surgical Innovations. Devices recorded under merged duplicate company entries are counted once.
Which registries list Synovis Surgical Innovations's devices?
Among its 9 most recently registered devices, Synovis Surgical Innovations has devices listed in FDA 510(k) (8 devices) and FDA PMA (1 device). A device can be listed in more than one registry, so these counts overlap.
What risk classes do Synovis Surgical Innovations's devices fall under?
Among its 9 most recently registered devices, the classes recorded for Synovis Surgical Innovations's devices are Class II and Class III. Each device page shows its own class and authorisation.
Are there FDA recall records for Synovis Surgical Innovations?
FDA recall records list 3 recalls initiated by Synovis Surgical Innovations, the most recent initiated on 2015-05-02. A recall is often a precaution started by the manufacturer; the records say nothing about the company's overall record.
What are the newest devices from Synovis Surgical Innovations in the registry?
The most recently registered devices listed for Synovis Surgical Innovations include VERITAS COLLAGEN MATRIX, SYNOVIS COLLAGEN MATRIX (TBD), PERI-STRIPS STAPLE LINE REINFORCEMENT - SLEEVE AND STRIP CONFIGURATIONS - AND PERI-STRIPS DRY STAPLE LINE REINFORCEMENT and STEERABLE STYLET.