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Advanced Surgical Innovations, Inc.

Canada · Mississauga Ontario

✓ Record-verifiedregistrations found in 4 markets

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

3listed device types

Class I 0Class II 2Class III 1

plus 9 registration records and 15 510(k)

UKUnited KingdomMHRA PARD

pendingnot queried

BRBrazilANVISA

4registered devices

Class II 4

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

SASaudi ArabiaSFDA

8registered imported devices

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

CACanadaMDALL

4active device licences

Class II 4

13 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 States9 registration records, 15 510(k), 0 PMA, 244 excluded

Brazil4 confirmed, 30 excluded

Saudi Arabia8 confirmed, 6 excluded

Canada4 confirmed, 38 excluded

Manufacturer names merged into this page: SURGICAL INNOVATIONS LTD · SURGICAL INNOVATIONS LIMITED · SURGICAL INNOVATIONS LTD.

FDA 510(k) clearances by year

11991

21994

21996

11997

12006

12007

22010

22012

12013

12019

12021

FDA listed device types

Electrosurgical, Cutting & Coagulation & Accessories 1Laparoscope, General & Plastic Surgery 1Tissue Adhesive Internal Use 1

Registration details (sample)

Market	Identifier	Name	Class / date
US	K210495	Port Access System	2021-06-18
US	K190592	YelloPort Elite Port Access System	2019-04-29
US	K123110	PRETZELFLEX SURGICAL RETRACTOR MODEL SHR7301	2013-01-17
BR	82412459003	YelloPort Elite 5mm	Class II
BR	82412459004	YelloPort Elite 5mm - Obturador	Class II
BR	82412459005	YelloPort Elite 5mm - Cânulas com Válvula Stopcock	Class II
SA	ME0000003139SFDAA00007	FastClamp Bariatric Bar	—
SA	ME0000003139SFDAA00011	Table Clamp	—
CA	69508	YELLOPORT CANNNULA	Class II
CA	87920	QUICK - SINGLE USE INSTRUMENTS FOR LAPAROSCOPIC SURGERY	Class II
CA	89677	YELLOPORT PLUS OPTICAL TROCAR	Class II

Advanced Surgical Innovations, 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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