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CADWELL INDUSTRIES, INC.

USA · Kennewick

✓ Record-verifiedregistrations found in 9 markets

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

24listed device types

Class I 1Class II 23Class III 0

plus 28 registration records and 13 510(k)

UKUnited KingdomMHRA PARD

pendingnot queried

BRBrazilANVISA

3registered devices

Class I 1Class II 2

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

SASaudi ArabiaSFDA

0registered imported devices

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

CACanadaMDALL

21active device licences

Class II 21

61 including historic records

TWTaiwanTFDA

10valid device licences

Class I 1Class II 9

SGSingaporeHSA SMDR

5device registrations

CLASS B 5

KRSouth KoreaMFDS GMP

1GMP quality-system certificates

Import 1

AUAustraliaTGA ARTG

3active ARTG entries

IIa 2Class Is (sterile) 1

HKHong KongMDACS

3valid listings

Class II 3

ILIsraelAMAR

4registrations

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 States28 registration records, 13 510(k), 0 PMA, 3 excluded

Brazil3 confirmed, 0 excluded

Canada21 confirmed, 0 excluded

Manufacturer names merged into this page: CADWELL INDUSTRIES, INC.

FDA 510(k) clearances by year

12014

12016

22017

22018

12019

22020

12023

12024

12025

12026

FDA listed device types

showing 8 of 24

System, Communication, Powered 1Electrode, Cortical 1Electromyograph, Diagnostic 1Device, Nerve Conduction Velocity Measurement 1Neurosurgical Nerve Locator 1Oximeter 1Device, Galvanic Skin Response Measurement 1Device, Sleep Assessment 1

Registration details (sample)

Market	Identifier	Name	Class / date
US	K261442	Charlotte ACC25 Surface Electrode Array; Charlotte ACC25 Reusable Surface Electrode Array	2026-06-26
US	K250851	Hypnos (369054-200)	2025-12-14
US	K242424	Bluebird Single-Use Respiratory Effort Belt	2024-12-18
BR	80386689020	Cascade Iomax	Class II
BR	80386689009	ELETRODO DE CONTATO ADESIVO	Class I
BR	80386689019	SIERRA SUMMIT	Class II
CA	3285	BIPOLAR CONCENTRIC NEEDLE ELECTRODE, REUSABLE	Class II
CA	3300	ELECTRICAL STIMULATOR-CONSTANT CURRENT LOW OUTPUT	Class II
CA	4639	AUDITORY STIMULATOR - ADULT HEADPHONES	Class II

CADWELL INDUSTRIES, 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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