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UNITED SURGICAL, LTD.

USA · Laotto

✓ Record-verifiedregistrations found in 3 markets

This company has registrations in United States, Brazil, Canada — 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

26listed device types

Class I 22Class II 4Class III 0

plus 33 registration records and 225 510(k)

UKUnited KingdomMHRA PARD

pendingnot queried

BRBrazilANVISA

13registered devices

Class II 13

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

37active device licences

Class II 18Class III 14Class IV 5

41 including historic records

TWTaiwanTFDA

pendingnot queried

SGSingaporeHSA SMDR

pendingnot queried

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 States33 registration records, 225 510(k), 0 PMA, 106 excluded

Brazil13 confirmed, 15 excluded

Saudi Arabia0 confirmed, 5 excluded

Canada37 confirmed, 8 excluded

Manufacturer names merged into this page: UNITED SURGICAL INDUSTRIES · UNITED SURGICAL LLC · UNITED SURGICAL, LTD. · UNITED STATES SURGICAL, A DIV. OF TYCO HEALTHCARE GROUP · UNITED STATES SURGICAL, A DIVISION OF TYCO HEALTHCARE GROUP, LP · UNITED STATES SURGICAL, A DIVISION OF TYCO HEALTHCARE GROUP

FDA 510(k) clearances by year

21988

71989

251990

161991

91992

111993

321994

171995

151996

131997

131998

81999

52000

62001

32002

32003

22004

12005

42006

22007

FDA listed device types

showing 8 of 26

Orthosis, Lumbar 1Splint, Hand, And Components 1Lift, Patient, Non-Ac-Powered 1Crutch 1Table, Surgical With Orthopedic Accessories, Manual 1Bed, Manual 1Orthosis, Limb Brace 1Binder, Abdominal 1

Registration details (sample)

Market	Identifier	Name	Class / date
US	K071406	AUTOSUTURE ENDO CLIP III 5 MM CLIP APPLIER	2007-11-21
US	K071920	AUTOSUTURE ABSORBABLE TACK AND APPLICATOR	2007-09-28
US	K061288	AUTO SUTURE ENDO CLIP III 5 MM CLIP APPLIER	2006-11-02
BR	10349000075	VISIPORT - TROCARTE OPTICO DESCARTAVEL COM CANULAAUTO SUTURE	Class II
BR	10349000004	VERSAPORT CÂNULA E TROCARTE DESCARTÁVEL AUTO SUTURE	Class II
BR	10349000117	ENDO CLOSE DISPOSITIVO DE SUTURA DESCARTAVEL AUTOSUTURE	Class II
CA	2842	CARDIOPLEGIA CANNULAE	Class II
CA	13384	VASCULAR THERAPIES TMLR SYSTEM	Class IV
CA	13513	SONOPSY SYSTEM	Class III

UNITED SURGICAL, LTD.

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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