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LEXION MEDICAL, LLC.

USA · St. Paul

✓ Record-verifiedregistrations found in 7 markets

This company has registrations in United States, Canada, Singapore, South Korea, Australia, Hong Kong, Israel — 7 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 6 registration records and 13 510(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

1active device licences

Class II 1

7 including historic records

TWTaiwanTFDA

pendingnot queried

SGSingaporeHSA SMDR

1device registrations

CLASS B 1

KRSouth KoreaMFDS GMP

1GMP quality-system certificates

Import 1

AUAustraliaTGA ARTG

4active ARTG entries

IIa 3Class Is (sterile) 1

HKHong KongMDACS

1valid listings

Class II 1

ILIsraelAMAR

1registrations

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 States6 registration records, 13 510(k), 0 PMA

Canada1 confirmed, 0 excluded

Manufacturer names merged into this page: LEXION MEDICAL, LLC. · LEXION MEDICAL, LLC

FDA 510(k) clearances by year

12007

32009

22010

12011

12012

22013

12014

12017

12019

FDA listed device types

Laparoscope, General & Plastic Surgery 1Insufflator, Endoscopic Vessel Harvesting 1Insufflator, Laparoscopic 1Tubing/Tubing With Filter, Insufflation, Laparoscopic 1Tube, Smoke Removal, Endoscopic 1

Registration details (sample)

Market	Identifier	Name	Class / date
US	K191780	AP50/30 Insufflator with Insuflow Port	2019-08-28
US	K170799	AP 50/30 Insufflator with Insuflow Port	2017-11-14
US	K140263	INSUFLOW SYNERGY PORT, INSUFLOW SYNERGY XL PORT	2014-03-05
CA	91929	INSUFLOW SYNERGY	Class II

LEXION MEDICAL, LLC.

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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