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Synovis Micro Companies Alliance, Inc.

USA · Birmingham

✓ Record-verifiedregistrations found in 5 markets

This company has registrations in United States, Saudi Arabia, Canada, Australia, Israel — 5 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

18listed device types

Class I 5Class II 13Class III 0

plus 21 registration records and 8 510(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

0active device licences

6 including historic records

TWTaiwanTFDA

0valid device licences

SGSingaporeHSA SMDR

pendingnot queried

KRSouth KoreaMFDS GMP

pendingnot queried

AUAustraliaTGA ARTG

11active ARTG entries

Class I 6IIa 3IIb 2

HKHong KongMDACS

pendingnot queried

ILIsraelAMAR

4registrations

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 States21 registration records, 8 510(k), 0 PMA, 7 excluded

Saudi Arabia1 confirmed, 0 excluded

Canada0 confirmed, 1 excluded

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

FDA 510(k) clearances by year

12004 · K040163

12010 · K093310

22019 · K190499

22022 · K221843

12024 · K233394

12025 · K242541

FDA listed device types

showing 8 of 18

Electrosurgical, Cutting & Coagulation & Accessories 1Suture, Nonabsorbable, Synthetic, Polyester 1Transducer, Ultrasonic, Diagnostic 1Flowmeter, Blood, Cardiovascular 1Suture, Nonabsorbable, Silk 1Suture, Nonabsorbable, Synthetic, Polypropylene 1System, Imaging, Pulsed Doppler, Ultrasonic 1Suture, Nonabsorbable, Synthetic, Polyethylene 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	—

Synovis Micro Companies Alliance, 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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