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MEDTRONIC POWERED SURGICAL SOLUTION

USA

✓ Record-verifiedregistrations found in 11 markets

This company has registrations in United States, Brazil, Saudi Arabia, Canada, Taiwan, Singapore, South Korea, Australia, Hong Kong, Israel, Russia — 11 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

15listed device types

Class I 7Class II 8Class III 0

plus 23 registration records and 10 510(k)

UKUnited KingdomMHRA PARD

pendingnot queried

BRBrazilANVISA

31registered devices

Class II 31

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

SASaudi ArabiaSFDA

12registered imported devices

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

CACanadaMDALL

6active device licences

Class II 6

23 including historic records

TWTaiwanTFDA

15valid device licences

Class II 15

SGSingaporeHSA SMDR

10device registrations

CLASS B 10

KRSouth KoreaMFDS GMP

1GMP quality-system certificates

Import 1

AUAustraliaTGA ARTG

14active ARTG entries

Class I 4IIa 9Class Is (sterile) 1

HKHong KongMDACS

5valid listings

Class II 5

ILIsraelAMAR

7registrations

RURussiaRoszdravnadzor

11active registrations

Class 2a 10Class 2b 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 States23 registration records, 10 510(k), 0 PMA

Brazil31 confirmed, 0 excluded

Saudi Arabia12 confirmed, 0 excluded

Canada6 confirmed, 0 excluded

Manufacturer names merged into this page: MEDTRONIC POWERED SURGICAL SOLUTIONS · MEDTRONIC POWERED SURGICAL SOLUTION · MEDTRONIC INC. POWERED SURGICAL SOLUTIONS · Medtronic Powered Surgical Solutions · Medtronic Powered Surgical

FDA 510(k) clearances by year

12007

12009

12016

32017

22019

12020

12021

FDA listed device types

showing 8 of 15

Drill, Surgical, Ent (Electric Or Pneumatic) Including Handpiece 1Motor, Drill, Pneumatic 1Parathyroid Autofluorescence Detection Device 1Arthroscope 1Neurological Stereotaxic Instrument 1Motor, Drill, Electric 1Orthopedic Stereotaxic Instrument 1Drills, Burrs, Trephines & Accessories (Simple, Powered) 1

Registration details (sample)

Market	Identifier	Name	Class / date
US	K213454	Midas Rex MR8 Depth Stop Attachment, Midas Rex MR8 Depth Stop Tool 2.4mm, Midas Rex MR8 Depth Stop Tool 3.2mm, Midas Rex MR8 Depth Stop Tool 3.2mm Long, Midas Rex MR8 Depth Stop Tool 7.5mm	2021-11-23
US	K202552	Midas Rex Attachments and Dissecting Tools	2020-11-02
US	K183644	Stealth-Midas MR8 System	2019-05-22
BR	10349009024	Brocas ENT MR8 aço inoxidável	Class II
BR	10349009025	Brocas ENT MR8 aço	Class II
BR	10349009026	Brocas ENT MR8 DIAMANTADA	Class II
SA	ME0000003850SFDAA00001	MIDAS REX™ Bone Mill	—
SA	ME0000003850SFDAA00003	Lubricant / Diffuser	—
CA	30898	MIDAS REX III MOTORS	Class II
CA	30899	MIDAS REX CLASSIC MOTORS	Class II
CA	30900	MIDAS REX QUICK RELEASE TUBES	Class II