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Microaire Surgical Instruments, Inc.

USA · Charlottesville

✓ Record-verifiedregistrations found in 10 markets

This company has registrations in United States, Brazil, Canada, Taiwan, Singapore, South Korea, Australia, Hong Kong, Israel, Russia — 10 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 17Class II 9Class III 0

plus 39 registration records and 16 510(k)

UKUnited KingdomMHRA PARD

pendingnot queried

BRBrazilANVISA

18registered devices

Class I 1Class II 17

20 including historic records

SASaudi ArabiaSFDA

0registered imported devices

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

CACanadaMDALL

5active device licences

Class II 5

19 including historic records

TWTaiwanTFDA

15valid device licences

Class I 8Class II 7

SGSingaporeHSA SMDR

9device registrations

CLASS B 7CLASS C 1CLASS D 1

KRSouth KoreaMFDS GMP

2GMP quality-system certificates

Import 2

AUAustraliaTGA ARTG

51active ARTG entries

Class I 16IIa 34Class Is (sterile) 1

HKHong KongMDACS

1valid listings

Class II 1

ILIsraelAMAR

4registrations

RURussiaRoszdravnadzor

6active registrations

Class 2a 5Class 3 1

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 States39 registration records, 16 510(k), 0 PMA, 2 excluded

Brazil18 confirmed, 1 excluded

Canada5 confirmed, 0 excluded

Manufacturer names merged into this page: MICROAIRE SURGICAL INSTRUMENTS LLC · MICROAIRE SURGICAL INSTRUMENTS · MICROAIRE SURGICAL INSTRUMENTS, LLC · MICROAIRE SURGICAL INSTRUMENTS, INC.

FDA 510(k) clearances by year

11996

11997

11998

12002

12012

12015

12017

12018

12020

12021

22022

12023

12024

22025

FDA listed device types

showing 8 of 26

Instrument, Surgical, Orthopedic, Dc-Powered Motor And Accessory/Attachment 1Chisel (Osteotome) 1Stand, Infusion 1Bur, Surgical, General & Plastic Surgery 1Bit, Drill 1Motor, Surgical Instrument, Pneumatic Powered 1Knife, Surgical 1Rasp, Surgical, General & Plastic Surgery 1

Registration details (sample)

Market	Identifier	Name	Class / date
US	K243589	PAL Sterilization Case	2025-06-20
US	K244026	PAL 7020 Console	2025-04-25
US	K242804	PAL Aspiration System	2024-12-30
BR	80020720002	Sistema Pneumático Série 1000 MicroAire	Class II
BR	80020720040	CÂNULA DE ASPIRAÇÃO ESTÉRIL HD - MICROAIRE	Class II
BR	80020720022	SISTEMA DE LIBERACAO DO TUNEL CARPAL MICROAIRE	Class II
CA	68005	PNEUMATIC POWERED BONE SAWS	Class II
CA	68130	PNEUMATIC POWER HAND PIECES	Class II
CA	70807	EPICUT	Class II