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Synovis Life Technologies, Inc.

USA · St. Paul

✓ Record-verifiedregistrations found in 3 markets

This company has registrations in United States, Canada, Singapore — 3 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

10listed device types

Class I 1Class II 9Class III 0

plus 17 registration records and 11 510(k)

UKUnited KingdomMHRA PARD

pendingnot queried

BRBrazilANVISA

0registered devices

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

SASaudi ArabiaSFDA

0registered imported devices

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

CACanadaMDALL

6active device licences

Class II 2Class IV 4

13 including historic records

TWTaiwanTFDA

pendingnot queried

SGSingaporeHSA SMDR

3device registrations

CLASS D 3

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 States17 registration records, 11 510(k), 0 PMA, 8 excluded

Saudi Arabia0 confirmed, 1 excluded

Canada6 confirmed, 1 excluded

Manufacturer names merged into this page: SYNOVIS LIFE TECHNOLOGIES, INC. (A Subsidiary of Baxter International Inc.) · SYNOVIS LIFE TECHNOLOGIES, INC. A SUBSIDIARY OF BAXTER INTERNATIONAL INC

FDA 510(k) clearances by year

22013

22014

22015

12019

12021

22022

12023

FDA listed device types

showing 8 of 10

Patch, Pledget And Intracardiac, Petp, Ptfe, Polypropylene 1Mesh, Surgical, Collagen, Staple Line Reinforcement 1Mesh, Surgical, Non-Synthetic, Urogynecologic, For Apical Vaginal And Uterine Prolapse, Transabdominally Placed 1Dura Substitute 1Mesh, Surgical, Collagen, Thoracic, Chest Wall Reconstruction 1Mesh, Surgical 1Intracardiac Patch Or Pledget, Biologically Derived 1Dilator, Vessel, Surgical 1

Registration details (sample)

Market	Identifier	Name	Class / date
US	K223052	Peri-Guard and Supple Peri-Guard	2023-04-07
US	K221029	PERI-GUARD Repair Patch, SUPPLE PERI-GUARD Repair Patch	2022-10-19
US	K221032	Vascu-Guard Vascular Repair Patch	2022-10-19
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 Life Technologies, 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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