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SYNOVIS MICRO COMPANIES ALLIANCE, INC. (a subsidiary of Baxter International Inc.)

USA · Birmingham

✓ Record-verifiedregistrations found in 4 markets

This company has registrations in United States, Saudi Arabia, Canada, Taiwan — 4 overseas markets. The China NMPA lookup is still pending.

Registrations by market

Each market counts a different unit; figures are not directly comparable

CNChinaNMPA

n/aThis registry lists domestic registrants only

EUEuropean UnionEUDAMED

pendingnot queried

USUnited StatesFDA openFDA

27listed device types

Class I 6Class II 21Class III 0

plus 38 registration records and 10 510(k)

UKUnited KingdomMHRA PARD

pendingnot queried

BRBrazilANVISA

0registered devices

this export covers Class I / II only (the cadastro route)

SASaudi ArabiaSFDA

1registered imported devices

low-risk imported devices only; a 2023 snapshot, not updated since

CACanadaMDALL

6active device licences

Class II 2Class IV 4

19 including historic records

TWTaiwanTFDA

1valid device licences

Class II 1

SGSingaporeHSA SMDR

pendingnot queried

KRSouth KoreaMFDS GMP

pendingnot queried

AUAustraliaTGA ARTG

pendingnot queried

HKHong KongMDACS

pendingnot queried

ILIsraelAMAR

pendingnot queried

RURussiaRoszdravnadzor

pendingnot queried

Not yet connected: India CDSCO, Indonesia Kemenkes. The public search for Japan PMDA and Vietnam IMDA does not return manufacturer names, so entries cannot be linked to companies coming — where there is no data it is shown as "pending", never estimated.

How these numbers were verified

record-verified

Company-name search in every official database is a substring match and returns same-named but different companies. Each figure below is the count after re-checking every record against the manufacturer name.

United States38 registration records, 10 510(k), 0 PMA, 4 excluded

Saudi Arabia1 confirmed, 0 excluded

Canada6 confirmed, 0 excluded

Manufacturer names merged into this page: SYNOVIS MICRO COMPANIES ALLIANCE, INC. (a subsidiary of Baxter International Inc.) · SYNOVIS LIFE TECHNOLOGIES, INC. (A Subsidiary of Baxter International Inc.) · SYNOVIS LIFE TECHNOLOGIES, INC. A SUBSIDIARY OF BAXTER INTERNATIONAL INC · SYNOVIS MICRO COMPANIES ALLIANCE, INC. (A SUBSIDIARY OF BAXTER INTERNATIONAL INC.) · Synovis Micro Companies Alliance, Inc.

Same-named companies — This database also contains companies with near-identical names: Baxter/ Synovis Micro Companies Alliance, Inc., Synovis Life Technologies. Inc. (A Subsidiary of Baxter, SYNOVIS LIFE TECHNOLOGIES, INC. (A Subsidiary of Baxter International Inc.), Synovis Life Technologies, Inc. (Baxter International Inc.). Company name alone cannot separate their registrations, so the figures below may include either.

FDA 510(k) clearances by year

12004

12010

32019

12021

22022

12024

12025

FDA listed device types

showing 8 of 27

Electrosurgical, Cutting & Coagulation & Accessories 1Mesh, Surgical, Collagen, Thoracic, Chest Wall Reconstruction 1Device, Anastomotic, Microvascular 1Sterilization Wrap Containers, Trays, Cassettes & Other Accessories 1Clip, Implantable 1Dilator, Vessel, Surgical 1Clamp, Vascular 1Mesh, Surgical, Collagen, Staple Line Reinforcement 1

Registration details (sample)

Market	Identifier	Name	Class / date
US	K242541	GEM ZIPCLIP	2025-01-15
US	K233394	Gem Flow Now (GEM2770-FN)	2024-01-28
US	K221843	GEM Biover Microvascular Clamps	2022-09-14
SA	ME0000011871SFDAA00003	GEM Microvascular Anastomotic COUPLER System	—
CA	60429	VERITAS COLLAGEN MATRIX	Class IV
CA	2149	FLO-RESTER SIZER	Class II
CA	7319	PERI-STRIPS STAPLE LINE REINFORCEMENT (SLEEVE AND STRIP)	Class IV

SYNOVIS MICRO COMPANIES ALLIANCE, INC. (a subsidiary of Baxter International Inc.)

Registrations by market

How these numbers were verified

Company information

FDA 510(k) clearances by year

FDA listed device types

Registration details (sample)

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