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Misonix Incorporated

USA · Farmingdale

✓ Record-verifiedregistrations found in 9 markets

This company has registrations in United States, Brazil, Canada, Taiwan, Singapore, South Korea, Australia, Israel, Russia — 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

6listed device types

Class I 0Class II 5Class III 0unclassified 1

plus 11 registration records and 18 510(k)

UKUnited KingdomMHRA PARD

pendingnot queried

BRBrazilANVISA

5registered devices

Class II 5

7 including historic records

SASaudi ArabiaSFDA

0registered imported devices

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

CACanadaMDALL

1active device licences

Class III 1

5 including historic records

TWTaiwanTFDA

5valid device licences

Class I 1Class II 4

SGSingaporeHSA SMDR

4device registrations

CLASS B 1CLASS C 1CLASS D 2

KRSouth KoreaMFDS GMP

1GMP quality-system certificates

Import 1

AUAustraliaTGA ARTG

22active ARTG entries

Class I 11IIa 6IIb 5

HKHong KongMDACS

pendingnot queried

ILIsraelAMAR

1registrations

RURussiaRoszdravnadzor

2active registrations

Class 2b 2

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 States11 registration records, 18 510(k), 0 PMA, 1 excluded

Brazil5 confirmed, 0 excluded

Canada1 confirmed, 0 excluded

Manufacturer names merged into this page: MISONIX, LLC · Misonix Incorporated · MISONIX, INC

FDA 510(k) clearances by year

11998

12000

12001

12002

12003

12004

22005

22006

12007

12008

12011

12013

12019

12021

12022

12026

FDA listed device types

Electrosurgical, Cutting & Coagulation & Accessories 1Wound Cleaner, Ultrasound 1System, Suction, Lipoplasty For Removal 1Lithotriptor, Ultrasonic 1Lavage, Jet 1Instrument, Ultrasonic Surgical 1

Registration details (sample)

Market	Identifier	Name	Class / date
US	K261448	neXus Ultrasonic Surgical Aspirator System	2026-07-30
US	K221235	neXus Ultrasonic Surgical Aspirator System	2022-07-28
US	K212060	neXus Ultrasonic Surgical Aspirator System	2021-12-13
BR	81000030030	Sistema aspiração/irrigação com cânula laparoscópica - Misonix	Class II
BR	81000030101	CORTADOR DE OSSO ULTRASÔNICO MISONIX BONESCALPEL	Class II
BR	81000030004	Kit cânula descartável de procedimento estéril Misonix	Class II
CA	84062	MISONIX ULTRASOUND ASSISTED LIPOSUCTION CONSOLE	Class III

Misonix Incorporated

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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