Data / Medical devices / United States / E-Z-Em, Inc.

E-Z-Em, Inc.: FDA-registered device maker in Princeton, NJ, United States, 5 510(k) clearances

Name: E-Z-Em, Inc. FDA registration, clearances, approvals and recalls
Creator: SpecStream
License: https://creativecommons.org/licenses/by/4.0/

E-Z-Em, Inc. is registered with the FDA (registration 2411512) in Princeton, NJ, United States. It lists 9 device types. The FDA files 5 510(k) clearances under its listings, the newest dated June 12, 2018. 1 recall event names it as the recalling firm. Registered through 2026. FDA data exported November 2, 2026.

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FDA registration number: 2411512
Address: 510 Carnegie Center, Princeton, NJ, United States, 08540
Owner or operator: Bracco Diagnostics Inc. (2411512)
Roles: Specification developer
First device listed: August 18, 1992
Registered through: 2026
Brand names listed: Accessory Package for use with CardioGen-82 Infusion System, BAGS, CYSTO AID, CYSTO-AID (TM) VOIDING AID, CardioGen-82 Infusion System, E-Z Mark, EMPTY ENEMA KITS, Elution Test Vial Bottle use with CardioGen-82 Infusion Syst and more

Devices it lists

Device	Product code	Class	Role	Source
Catheter, Retention, Barium Enema With Bag	FGD	2	Specification developer	accessdata.fda.gov
Container, Liquid Medication, Graduated	KYW	1	Specification developer	accessdata.fda.gov
Container, Specimen, Sterile	FMH	1	Specification developer	accessdata.fda.gov
Insufflator, Automatic Carbon-Dioxide For Endoscope	FCX	2	Specification developer	accessdata.fda.gov
Pump, Infusion	FRN	2	Specification developer	accessdata.fda.gov
Shield, Vial	IWW	1	Specification developer	accessdata.fda.gov
System, Tomography, Computed, Emission	KPS	2	Specification developer	accessdata.fda.gov
System, X-Ray, Film Marking, Radiographic	JAC	1	Specification developer	accessdata.fda.gov
Urinal	FNP	1	Specification developer	accessdata.fda.gov

510(k) clearances

The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.

Decided	510(k) number	Device	Product code	Decision	Applicant	Source
June 12, 2018	K181343	HeartSee Cardiac P.E.T. Processing Software	KPS	Substantially Equivalent	Bracco Diagnostics, Inc.	accessdata.fda.gov
February 14, 2014	K132192	BRACCO DIAGNOSTICS INC. PROTOCO, L TOUCH COLON INSUFFLATOR	FCX	Substantially Equivalent	Bracco Diagnostic, Inc.	accessdata.fda.gov
April 16, 2003	K030854	PROTOCO2L COLON INSUFFLATOR WITH PERFORMANCE IMPROVEMENTS, MODEL 6400	FCX	Substantially Equivalent	E-Z-Em, Inc.	accessdata.fda.gov
April 14, 1989	K883609	ACCES. PACKAGE FOR USE W/CARDIOGEN-82 GENERATOR	FRN	Substantially Equivalent	Squibb Diagnostics	accessdata.fda.gov
October 19, 1984	K842568	RADIONUCLIDE INFUSION SYSTEM	FRN	Substantially Equivalent	Squibb Diagnostics	accessdata.fda.gov

Recalls

Recall events where this establishment is the recalling firm, matched on its FEI.

Initiated	Event	Class	Status	Product	Reason	Source
December 3, 2004	31007	Not yet classified	Terminated	Brand Name: EmpowerCT/EmpowerCTA Injector System Ceiling Column Accessory; Common/Usual Name: CT Injector System Ceiling Column Accessory, Catalog Number 9886S. Ceiling Column Accessory: The CT and CTA Injector Systems e	Out of specification welding could cause the ceiling mount accessory to detach from its mounting. The firm received 1 complaint from a hospital that the injector fell off the ceiling mounting bracket and landed on the floor.	accessdata.fda.gov

Compare with other makers

Updated June 12, 2018. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.