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Burton Medical LLC

USA · Addison
✓ Record-verifiedregistrations found in 3 markets

This company has registrations in United States, Saudi Arabia, Israel — 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
4listed device types
Class I 2Class II 2Class III 0
plus 7 registration records and 15 510(k)
UKUnited KingdomMHRA PARD
pendingnot queried
BRBrazilANVISA
0registered devices
this export covers Class I / II only (the cadastro route)
SASaudi ArabiaSFDA
4registered imported devices
low-risk imported devices only; a 2023 snapshot, not updated since
CACanadaMDALL
0active device licences
TWTaiwanTFDA
pendingnot queried
SGSingaporeHSA SMDR
pendingnot queried
KRSouth KoreaMFDS GMP
pendingnot queried
AUAustraliaTGA ARTG
pendingnot queried
HKHong KongMDACS
pendingnot queried
ILIsraelAMAR
2registrations
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 States7 registration records, 15 510(k), 0 PMA, 5 excluded
Saudi Arabia4 confirmed, 0 excluded
Manufacturer names merged into this page: Burton Medical LLC
Same-named companies — This database also contains companies with near-identical names: Burton Medical Products Corp.. Company name alone cannot separate their registrations, so the figures below may include either.

Company information

Country
USA
City
Addison

Fields marked "pending" have not been obtained yet; that does not mean they do not exist. Risk records (litigation, penalties, operating anomalies) are kept internal and not published.

FDA 510(k) clearances by year

11985
21986
21989
11990
11993
31994
21996
12000
12004
12010

FDA listed device types

Light, Surgical, Floor Standing 1Light, Surgical, Ceiling Mounted 1Headlamp, Operating, Battery-Operated 1Device, Medical Examination, Ac Powered 1

Registration details (sample)

MarketIdentifierNameClass / date
USK101537AIM 200, MAJOR SURGICAL LIGHT2010-09-30
USK042395OUTPATIENT III MINOR SURGERY LIGHT2004-12-01
USK000639VISIONARY 20002000-05-25
SAME0000022513SFDAA00001NOVA Exam LED—
SAME0000022513SFDAA00002Outpatient LED—

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