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MEDTRONIC XOMED, INC.

USA · Jacksonville

✓ 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

84listed device types

Class I 32Class II 50Class III 0unclassified 2

plus 151 registration records and 46 510(k), 9 PMA

UKUnited KingdomMHRA PARD

pendingnot queried

BRBrazilANVISA

74registered devices

Class I 17Class II 57

83 including historic records

SASaudi ArabiaSFDA

22registered imported devices

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

CACanadaMDALL

55active device licences

Class II 43Class III 12

153 including historic records

TWTaiwanTFDA

28valid device licences

Class I 7Class II 21

SGSingaporeHSA SMDR

47device registrations

CLASS B 27CLASS C 13CLASS D 7

KRSouth KoreaMFDS GMP

2GMP quality-system certificates

Import 2

AUAustraliaTGA ARTG

53active ARTG entries

Class I 17Class III 1IIa 21IIb 3Class Im (measuring) 1Class Is (sterile) 10

HKHong KongMDACS

9valid listings

Class II 9

ILIsraelAMAR

29registrations

RURussiaRoszdravnadzor

17active registrations

Class 2a 11Class 2b 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 States151 registration records, 46 510(k), 9 PMA, 2 excluded

Brazil74 confirmed, 0 excluded

Saudi Arabia22 confirmed, 0 excluded

Canada55 confirmed, 0 excluded

Manufacturer names merged into this page: MEDTRONIC XOMED, INC. · MEDTRONIC XOMED INC. · MEDTRONIC XOMED INC · MEDTRONIC XOMED INC · Medtronic Xomed Inc. · Medtronic Xomed, Inc.

FDA 510(k) clearances by year

11999

32000

42001

22002

32003

42004

12005

22006

42008

12009

12011

42012

22013

42015

12018

22020

12021

12022

22023

12026

FDA listed device types

showing 8 of 84

Electrode, Needle 1Polymer, Ent Synthetic-Polyamide (Mesh Or Foil Material) 1Thoracolumbosacral Pedicle Screw System 1Appliance, Fixation, Spinal Intervertebral Body 1Posterior Metal/Polymer Spinal System, Fusion 1Parathyroid Autofluorescence Detection Device 1Electromyograph, Diagnostic 1System, Suction, Lipoplasty For Removal 1

Registration details (sample)

Market	Identifier	Name	Class / date
US	K251672	NIM Essence EMG Endotracheal Tube (NIMEID060); NIM Essence EMG Endotracheal Tube (NIMEID065); NIM Essence EMG Endotracheal Tube (NIMEID070); NIM Essence EMG Endotracheal Tube (NIMEID075); NIM Essence EMG Endotracheal Tube (NIMEID080)	2026-02-10
US	K230320	NIM Standard Reinforced EMG Endotracheal Tube; CONTACT Reinforced EMG Endotracheal Tube	2023-10-26
US	K231580	NIM 35cm long Surgeon Control Probe, 1mm Ball-Tip (NIMDTP35)	2023-08-30
BR	10173550006	TAMPAO NASAL MEROCEL SEM CANULA XOMED	Class II
BR	10173550001	TAMPAO NASAL MEROCEL COM CANULA	Class II
BR	10173550032	LÂMINAS PARA SISTEMA DEBRIADOR	Class II
SA	ME0000009243SFDAA00001	Sharpsite Flexible ENT Scope	—
SA	ME0000008865SFDAA00001	Skeeter Ultra-Lite Sterilization Case	—
CA	80699	XOMED HYDRODEBRIDER HANDPIECE	Class II
CA	86600	SHARPSITE FLEXIBLE ENT SCOPE	Class II
CA	1318	PARELL T-STENT FRONTAL SINUS STENT	Class II