510(k) Report

FDA applicant

Synovis Micro Companies Alliance, Inc.

Birmingham, AL5 decisions2004–20241 recall

FDA records 5 decisions for Synovis Micro Companies Alliance, Inc. (Birmingham, AL) from 2004 to 2024: 5 510(k) clearances. Most are in product codes MVR (Device, Anastomotic, Microvascular) and DXC (Clamp, Vascular). Its devices cite 4 predicates, 0 of them its own earlier devices. 1 recall is linked to its devices.

FDA’s records also spell it “Synovis Micro Companies Alliance”.

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 Micro Companies Alliance, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2024

2010: 12022: 22024: 1
2007high 2 (2022) · low 0 (2007)2026

2026 so far, outlined.

Recalls per year

1in 2008

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

Class I Class II/III not classified

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

Planning a device like Synovis Micro Companies Alliance, Inc.’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.

See the 510(k) Report

Which product codes does it file in?

  • MVRDevice, Anastomotic, Microvascular2decisions
  • DXCClamp, Vascular1decision
  • DPWFlowmeter, Blood, Cardiovascular1decision
  • IYNSystem, Imaging, Pulsed Doppler, Ultrasonic1decision

Whose devices does it build on?

Its devices cite 4 predicates; 0 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 4 times; 0 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.

  • K093310Gem Flow Coupler Device and SystemSynovis Micro Companies Alliance, Inc. · 20103cite it
  • K040163Microvascular Anastomotic DeviceSynovis Micro Companies Alliance, Inc. · 20041cites it

What has FDA decided for it lately?

  • K233394Gem Flow Now (GEM2770-FN)Synovis Micro Companies Alliance · 2024
  • K221843GEM Biover Microvascular ClampsSynovis Micro Companies Alliance, Inc. · 2022
  • K213974GEM FLOW COUPLER Monitor (GEM1020M-2)Synovis Micro Companies Alliance, Inc. · 2022
  • K093310Gem Flow Coupler Device and SystemSynovis Micro Companies Alliance, Inc. · 2010
  • K040163Microvascular Anastomotic DeviceSynovis Micro Companies Alliance, Inc. · 20041 recall

All 4 as Synovis Micro Companies Alliance, Inc. →The one decision as Synovis Micro Companies Alliance →

What has been recalled?

1 recall linked to its devices; the latest:

  • K040163GEM 2753 Microvascular Anastomotic Coupler, 2.5 mm, REF GEM2753/I, P/N 5111-00250-010…May 14, 2008

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 Surgical Innovations 9Synovis 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