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Lone Star Medical Products, Inc.

USA · Stafford

✓ Record-verifiedregistrations found in 4 markets

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

5listed device types

Class I 2Class II 3Class III 0

plus 8 registration records and 6 510(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

0active device licences

6 including historic records

TWTaiwanTFDA

0valid device licences

SGSingaporeHSA SMDR

2device registrations

CLASS B 1CLASS C 1

KRSouth KoreaMFDS GMP

pendingnot queried

AUAustraliaTGA ARTG

2active ARTG entries

Class I 1IIa 1

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 States8 registration records, 6 510(k), 0 PMA, 3 excluded

Canada0 confirmed, 1 excluded

Manufacturer names merged into this page: Lone Star Medical Products · COOPERSURGICAL, INC., ALSO TRADING AS LONE STAR MEDICAL PRODUCTS

Same-named companies — This database also contains companies with near-identical names: COOPERSURGICAL, INC., ALSO TRADING AS LONE STAR MEDICAL PRODUCTS. Company name alone cannot separate their registrations, so the figures below may include either.

FDA 510(k) clearances by year

11979 · K791665

11980 · K802983

11981 · K810915

11982 · K820015

11984 · K831531

11985 · K850041

FDA listed device types

Trocar 1Cannula, Manipulator/Injector, Uterine 1Culdoscope (And Accessories) 1Surgical Instruments, G-U, Manual (And Accessories) 1Retractor 1

Market	Identifier	Name	Class / date
US	K850041	P-3 CLOSING INSTRUMENT	1985-02-21
US	K831531	SURGICAL ISOLATION BARRIER SYSTEM	1984-06-05
US	K820015	URETHAL CUTTER CLAMP	1982-02-22

Lone Star Medical Products, 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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