Data / Medical devices / Switzerland / Bracco Injeneering S.A.

Bracco Injeneering S.A.: FDA-registered device maker in LAUSANNE Vaud, Switzerland, 10 510(k) clearances

Name: Bracco Injeneering S.A. FDA registration, clearances, approvals and recalls
Creator: SpecStream
License: https://creativecommons.org/licenses/by/4.0/

Bracco Injeneering S.A. is registered with the FDA (registration 3004753774) in LAUSANNE Vaud, Switzerland. It lists 6 device types. The FDA files 10 510(k) clearances under its listings, the newest dated June 20, 2014. 1 recall event names it as the recalling firm. Registered through 2027. FDA data exported November 2, 2026.

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FDA registration number: 3004753774
Address: Avenue De Sevelin 46, LAUSANNE Vaud, Switzerland, 1004
Owner or operator: Bracco Injeneering (9066379)
Roles: Manufacturer, Specification developer
First device listed: April 14, 2014
Registered through: 2027
Brand names listed: Bracco Injeneering Transfer Set, EmpowerCTA+ Injector System, EmpowerMR® Injector System, FastLoad¿ CT Syringe Pack, FastLoad¿ CT Syringe Pack with spike, FastLoad¿ CTA dual Syringe Pack, FastLoad¿ CTA dual Syringe Pack with spikes, FastLoad¿ MR Syringe Pack

Devices it lists

Device	Product code	Class	Role	Source
Injector And Syringe, Angiographic	DXT	2	Specification developer	accessdata.fda.gov
Injector, Contrast Medium, Automatic	IZQ	2	Manufacturer, Specification developer	accessdata.fda.gov
Iodinated Contrast Media Transfer Tubing Set	PQH	2	Specification developer	accessdata.fda.gov
Plethysmograph, Impedance	DSB	2	Manufacturer, Specification developer	accessdata.fda.gov
Pump, Infusion Or Syringe, Extra-Luminal	FIH	2	Specification developer	accessdata.fda.gov
System, X-Ray, Tomography, Computed	JAK	2	Manufacturer, 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 20, 2014	K133147	BRACCO INJEENERING TRANSFER SET	PQH	Substantially Equivalent	Bracco Injeneering S.A.	accessdata.fda.gov
June 13, 2007	K071378	MODIFICATION TO EMPOWER CT/CTA INJECTOR SYSTEM, MODELS 9800/9900 PRODUCT SERIES	JAK	Substantially Equivalent	E-Z-Em, Inc.	accessdata.fda.gov
April 13, 2007	K062449	EMPOWERMR INJECTOR SYSTEM, MODEL 9730	IZQ	Substantially Equivalent	E-Z-Em, Inc.	accessdata.fda.gov
November 2, 2006	K063029	EMPOWER CT/CTA INJECTOR SYSTEM, MODEL 9800/9900	JAK	Substantially Equivalent	E-Z-Em, Inc.	accessdata.fda.gov
June 19, 2003	K031571	EMPOWERCTA INJECTOR SYSTEM, MODELS 9930 & 9910 & 9825	IZQ	Substantially Equivalent	E-Z-Em, Inc.	accessdata.fda.gov
May 16, 2001	K011160	E-Z EM PERCUPUMP 2001 CT INJECTOR	JAK	Substantially Equivalent	E-Z-Em, Inc.	accessdata.fda.gov
January 27, 1998	K974621	PERCUPUMP II WITH EDA	DSB	Substantially Equivalent	E-Z-Em, Inc.	accessdata.fda.gov
January 23, 1997	K961845	PERCUPUMP II WITH EDA	DSB	Substantially Equivalent	E-Z-Em, Inc.	accessdata.fda.gov
March 21, 1995	K932055	PERCUPUMP II	FIH	Substantially Equivalent	E-Z-Em, Inc.	accessdata.fda.gov
December 13, 1994	K933846	ANGIOGRAPHY SYRINGE KITS	DXT	Substantially Equivalent	Angiodynamics, Div. E-Z-Em, Inc.	accessdata.fda.gov

Recalls

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

Initiated	Event	Class	Status	Product	Reason	Source
November 12, 2018	81616	Class II	Terminated	Empower FastLoad CT Syringe Pack -sterile disposable syringe kit for use with the EmpowerCT, EmpowerCTA and EmpowerCTA+ Injector Systems SKU 017344/6720 Empower FastLoad" CT Syringe Pack is a sterile, disposable syringe	Insufficient seal on the sterile barrier of the device, compromising the sterility of the device	accessdata.fda.gov

Compare with other makers

Updated June 20, 2014. 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.