HomeUSALsi Solutions, Inc.

Lsi Solutions, Inc.

USA · Victor
✓ Record-verifiedregistrations found in 9 markets

This company has registrations in United States, Brazil, Canada, Taiwan, Singapore, South Korea, Australia, Hong Kong, Israel — 9 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
20listed device types
Class I 10Class II 10Class III 0
plus 21 registration records and 15 510(k)
UKUnited KingdomMHRA PARD
pendingnot queried
BRBrazilANVISA
0registered devices
3 including historic records
SASaudi ArabiaSFDA
0registered imported devices
low-risk imported devices only; a 2023 snapshot, not updated since
CACanadaMDALL
0active device licences
10 including historic records
TWTaiwanTFDA
3valid device licences
Class I 1Class II 2
SGSingaporeHSA SMDR
2device registrations
CLASS D 2
KRSouth KoreaMFDS GMP
1GMP quality-system certificates
Import 1
AUAustraliaTGA ARTG
10active ARTG entries
Class III 7IIa 1Class Is (sterile) 2
HKHong KongMDACS
2valid listings
Class IV 2
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 States21 registration records, 15 510(k), 0 PMA, 1 excluded
Brazil0 confirmed, 1 excluded
Canada0 confirmed, 1 excluded
Manufacturer names merged into this page: LSI SOLUTIONS INC. · LSI SOLUTIONS, INC.

Company information

Country
USA
City
Victor

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

11997
11998
12001
22003
12004
12010
12012
12016
12017
22020
12021
22024

FDA listed device types

showing 8 of 20
Instrument, Ligature Passing And Knot Tying 1Cannula, Surgical, General & Plastic Surgery 1Retention Device, Suture 1Sound, Urethral, Metal Or Plastic 1Retractor 1Hysteroscope Accessories 1Guide, Needle, Surgical 1Instrument, Manual, Surgical, General Use 1

Registration details (sample)

MarketIdentifierNameClass / date
USDEN230069Mi-CHORD System2024-06-11
USK222783MD Mattress Suture Placement Device2024-01-12
USK202551Cor-Knot Micro2021-06-24

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