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XODUS MEDICAL, INC.

USA · New Kensington

✓ Record-verifiedregistrations found in 6 markets

This company has registrations in United States, Brazil, Saudi Arabia, Taiwan, Australia, Israel — 6 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

30listed device types

Class I 24Class II 6Class III 0

plus 58 registration records and 6 510(k)

UKUnited KingdomMHRA PARD

pendingnot queried

BRBrazilANVISA

2registered devices

Class I 2

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

SASaudi ArabiaSFDA

9registered imported devices

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

CACanadaMDALL

0active device licences

TWTaiwanTFDA

1valid device licences

Class I 1

SGSingaporeHSA SMDR

pendingnot queried

KRSouth KoreaMFDS GMP

pendingnot queried

AUAustraliaTGA ARTG

22active ARTG entries

Class I 13IIa 2Class Is (sterile) 7

HKHong KongMDACS

pendingnot queried

ILIsraelAMAR

5registrations

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 States58 registration records, 6 510(k), 0 PMA

Brazil2 confirmed, 0 excluded

Saudi Arabia9 confirmed, 0 excluded

Manufacturer names merged into this page: XODUS MEDICAL, INC. · Shanghai Xodus Medical Company Limited · XODUS MEDICAL · Xodus Medical Inc.

FDA 510(k) clearances by year

22006 · K053321

12007 · K063587

12008 · K081647

12018 · K182080

12026 · K260903

FDA listed device types

showing 8 of 30

Stretcher, Hand-Carried 1Marker, Skin 1Label Or Tag, Sterile 1Handle, Scalpel 1Blade, Scalpel 1Scale, Surgical Sponge 1Device, Transfer, Patient, Manual 1Component, Traction, Non-Invasive 1

Registration details (sample)

Market	Identifier	Name	Class / date
US	K260903	Hot Pink Pad Warming System	2026-04-16
US	K182080	Scope Antifogging System	2018-09-19
US	K081647	ELECTROSURGICAL PENCIL WITH PTFE COATED & UNCOATED ELECTRODE TIPS	2008-08-12
BR	10315990069	SUPORTE EM GEL PARA ACOMODAÇÃO DE PACIENTE	Class I
BR	10315990070	SUPORTE EM ESPUMA PARA ACOMODAÇÃO DE PACIENTE	Class I
SA	ME0000005647SFDAA00004	PinkProtect positioning kit for the ICU	—
SA	ME0000005647SFDAA00010	Small Armboard	—

XODUS MEDICAL, INC.

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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