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E-Z-EM, INC.

USA · Princeton

✓ 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

9listed device types

Class I 5Class II 4Class III 0

plus 11 registration records and 56 510(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

0valid device licences

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 States11 registration records, 56 510(k), 0 PMA, 12 excluded

Brazil0 confirmed, 36 excluded

Saudi Arabia0 confirmed, 1 excluded

Canada0 confirmed, 4 excluded

Manufacturer names merged into this page: E-Z-EM, INC.

FDA 510(k) clearances by year

71985

11986

11987

11988

61989

21990

81991

81992

11994

11995

11996

11997

11998

12001

12002

22003

12004

12005

12006

22007

FDA listed device types

showing 8 of 9

Container, Specimen, Sterile 1Container, Liquid Medication, Graduated 1Shield, Vial 1Urinal 1System, X-Ray, Film Marking, Radiographic 1System, Tomography, Computed, Emission 1Pump, Infusion 1Insufflator, Automatic Carbon-Dioxide For Endoscope 1

Registration details (sample)

Market	Identifier	Name	Class / date
US	K071378	MODIFICATION TO EMPOWER CT/CTA INJECTOR SYSTEM, MODELS 9800/9900 PRODUCT SERIES	2007-06-13
US	K062449	EMPOWERMR INJECTOR SYSTEM, MODEL 9730	2007-04-13
US	K063029	EMPOWER CT/CTA INJECTOR SYSTEM, MODEL 9800/9900	2006-11-02

E-Z-EM, 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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