510(k) Report

FDA applicant

Synovis Surgical Innovations

St. Paul, MN9 decisions1979–201310 recalls

FDA records 9 decisions for Synovis Surgical Innovations (St. Paul, MN) from 1979 to 2013: 8 510(k) clearances and 1 original PMA approval. Most are in product codes FTM (Mesh, Surgical) and DXZ (Patch, Pledget And Intracardiac, Petp, Ptfe…). Its devices cite 30 predicates, 8 of them its own earlier devices. 10 recalls are linked to its devices.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly, last Nov 3, 2026

FIG. A — Illustration, general and plastic surgery panel, where it files most

How often FDA has decided Synovis Surgical Innovations’s devices, and how often a recall has named them.

FDA decisions per year

1in 2013

2008: 12013: 1
2007high 1 (2008) · low 0 (2007)2026

2026 so far, outlined.

Recalls per year

1in 2020

2007: 62010: 12011: 12020: 1
2007high 6 (2007) · low 0 (2008)2026

Class I Class II/III not classified

FIG. 1 — Synovis Surgical Innovations by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Which product codes does it file in?

  • FTMMesh, Surgical4decisions
  • DXZPatch, Pledget And Intracardiac, Petp, Ptfe, Polypropylene2decisions
  • LXATissue Graft Of 6mm And Greater1decision
  • OXEMesh, Surgical, Collagen, Staple Line Reinforcement1decision
  • DRBStylet, Catheter1decision

Whose devices does it build on?

Its devices cite 30 predicates; 8 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 20 times; 8 of those are its own. The firms that cite it most:

Which of its devices are cited most?

Its devices that later submissions most often claim equivalence to.

  • K062915Veritas Collagen MatrixSynovis Surgical Innovations · 20065cite it
  • K030879Veritas Collagen MatrixSynovis Surgical Innovations · 20034cite it
  • K040415Peri-Strips Staple Line Reinforcement - Sleeve and Strip Configurations - and Peri-Strips Dry Staple Line…Synovis Surgical Innovations · 20044cite it
  • K040119Peri-Strips Staple Line Reinforcement-Sleeve Configuration, Peri-Strips Staple Line Reinforcement-Strip…Synovis Surgical Innovations · 20043cite it
  • K041669Veritas Dry Collagen Matrix, Veritas Dry or Veritas PSDSynovis Surgical Innovations · 20043cite it
  • K083039Veritas Collagen Matrix (Dry)Synovis Surgical Innovations · 20081cites it

What has FDA decided for it lately?

  • K122306Synovis Collagen Matrix (TBD)Synovis Surgical Innovations · 2013
  • K083039Veritas Collagen Matrix (Dry)Synovis Surgical Innovations · 2008
  • K062915Veritas Collagen MatrixSynovis Surgical Innovations · 20061 recall
  • K041669Veritas Dry Collagen Matrix, Veritas Dry or Veritas PSDSynovis Surgical Innovations · 20048 recalls
  • K040415Peri-Strips Staple Line Reinforcement - Sleeve and Strip Configurations - and Peri-Strips Dry Staple Line…Synovis Surgical Innovations · 20041 recall
  • K040119Peri-Strips Staple Line Reinforcement-Sleeve Configuration, Peri-Strips Staple Line Reinforcement-Strip…Synovis Surgical Innovations · 2004
  • K040001Steerable StyletSynovis Surgical Innovations · 2004
  • K030879Veritas Collagen MatrixSynovis Surgical Innovations · 2003

All 9 as Synovis Surgical Innovations →

What has been recalled?

10 recalls linked to its devices; the latest:

  • K062915VERITAS Collagen Matrix - Product Usage: intended for use in reconstruction of the…Dec 11, 2020Class II
  • K041669Peri-Strips Dry with Veritas Collagen Matrix Staple Line Reinforcement (PSDV), sterile…Oct 26, 2011
  • K040415PSD Gel that's provided with Peri-Strips Dry Staple Line Reinforcement with Apex…Jun 30, 2010
  • K041669Synovis Peri-Strips Dry with Veritas Collagen Matrix Circular Staple Line Reinforcement…Mar 16, 2007
  • K041669Synovis Peri-Strips Dry with Veritas Collagen Matrix Circular Staple Line Reinforcement…Mar 16, 2007
  • K041669Synovis Peri-Strips Dry with Veritas Collagen Matrix Circular Staple Line Reinforcement…Mar 16, 2007

Other applicant names beginning “Synovis”

FDA records each applicant name separately; these may or may not be the same firm.

Synovis Life Technologies, Inc. 9Synovis Micro Companies Alliance, Inc. 5Synovis Orthopedic & Woundcare 3Synovis Orthopedic and Woundcare, Inc. 1Synovis Life Technologies. Inc. (A Subsidiary of Baxter 1Synovis Micro Companies Alliance A Subsidiary of… 1Synovis Life Technologies, Inc. (Baxter International… 1