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W. L. Gore and Associates, Inc.

USA · Flagstaff

✓ Record-verifiedregistrations found in 8 markets

This company has registrations in United States, Brazil, Canada, Taiwan, Singapore, Australia, Hong Kong, Israel — 8 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

23listed device types

Class I 0Class II 14Class III 8unclassified 1

plus 54 registration records and 170 510(k), 1,007 PMA

UKUnited KingdomMHRA PARD

pendingnot queried

BRBrazilANVISA

0registered devices

50 including historic records

SASaudi ArabiaSFDA

0registered imported devices

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

CACanadaMDALL

14active device licences

Class II 6Class III 7Class IV 1

40 including historic records

TWTaiwanTFDA

14valid device licences

Class II 9Class III 5

SGSingaporeHSA SMDR

17device registrations

CLASS B 1CLASS C 4CLASS D 12

KRSouth KoreaMFDS GMP

pendingnot queried

AUAustraliaTGA ARTG

38active ARTG entries

Class III 36IIb 2

HKHong KongMDACS

10valid listings

Class IV 10

ILIsraelAMAR

12registrations

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 States54 registration records, 170 510(k), 1,007 PMA, 2 excluded

Canada14 confirmed, 0 excluded

Manufacturer names merged into this page: W. L. GORE & ASSOCIATES, INC. · W. L. GORE & ASSOCIATES, INC · W. L. Gore & Associates, Inc. · W.L. GORE & ASSOCIATES, INC. · W.L. GORE & ASSOCIATES DO BRASIL LTDA. · W.L. GORE & ASSOCIATES, INC (N. FOURTH STREET)

Same-named companies — This database also contains companies with near-identical names: W.L. GORE & ASSOCIATES DO BRASIL LTDA., W.L. Gore & Associates, Inc. Medical Products Div.. Company name alone cannot separate their registrations, so the figures below may include either.

FDA 510(k) clearances by year

42004

32005

32006

22007

42008

22009

22010

12011

42012

22013

12014

22015

12016

32017

42018

12019

12022

22023

22024

12025

FDA listed device types

showing 8 of 23

Patch, Pledget And Intracardiac, Petp, Ptfe, Polypropylene 1Mesh, Surgical, Absorbable, Abdominal Hernia 1Mesh, Surgical, Absorbable, Plastic And Reconstructive Surgery 1Dura Substitute 1Suture, Nonabsorbable, Synthetic, Polypropylene 1Mesh, Surgical, Absorbable, Staple Line Reinforcement 1Prosthesis, Vascular Graft, Of Less Then 6mm Diameter 1Prosthesis, Vascular Graft, Of 6mm And Greater Diameter 1

Registration details (sample)

Market	Identifier	Name	Class / date
US	K250410	GORE® Tri-Lobe Balloon Catheter	2025-06-02
US	K240083	GORE® PROPATEN® Vascular Graft	2024-03-01
US	K232312	GORE® PROPATEN® Vascular Graft	2024-01-09
CA	11065	TISSUE SUPPORT AND LIGATURE	Class III
CA	19661	GORE EXTERNAL VALUE SUPPORT DEVICE	Class III
CA	76558	GORE INTRODUCER SHEATH	Class II

W. L. Gore and Associates, 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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