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Isomedix Operations, Inc.

USA · Grand Prairie

✓ Record-verifiedregistrations found in 1 markets

This company has registrations in United States — 1 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

1,235listed device types

Class I 360Class II 740Class III 103unclassified 32

plus 7,076 registration records and 2 510(k)

UKUnited KingdomMHRA PARD

pendingnot queried

BRBrazilANVISA

0registered devices

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

0active device licences

TWTaiwanTFDA

pendingnot queried

SGSingaporeHSA SMDR

pendingnot queried

KRSouth KoreaMFDS GMP

pendingnot queried

AUAustraliaTGA ARTG

pendingnot queried

HKHong KongMDACS

pendingnot queried

ILIsraelAMAR

pendingnot queried

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 States7,076 registration records, 2 510(k), 0 PMA, 1 excluded

Manufacturer names merged into this page: Isomedix Operations Inc. · ISOMEDIX OPERATIONS INC. · Isomedix Operations, Inc. · Isomedix Operations, Inc

FDA 510(k) clearances by year

11995 · K950047

11997 · K970352

FDA listed device types

showing 8 of 1,235

Stimulator, Hypoglossal Nerve, Implanted, Apnea 1System, Appendage Closure, Left Atrial 1Device, Hemostasis, Vascular 1Electrical Tumor Treatment Fields For Non-Small Cell Lung Cancer 1Stimulator, Electrical, Implantable, For Incontinence 1Implanted Fecal Incontinence Device 1Prosthesis, Posterior Spinal Elements 1Transcatheter Septal Occluder 1

Market	Identifier	Name	Class / date
US	K970352	SMARTVAC SMOKE EVACUATION SYSTEM	1997-11-04
US	K950047	SCHNEIDER GEX(TM) .014/.018 GUIDEWIRE EXCHANGE CATHETER	1995-04-05

Isomedix Operations, 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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