Data / Medical devices / United States / Bard Brachytherapy, Inc

Bard Brachytherapy, Inc: FDA-registered device maker in Carol Stream, IL, United States, 4 510(k) clearances

Name: Bard Brachytherapy, Inc FDA registration, clearances, approvals and recalls
Creator: SpecStream
License: https://creativecommons.org/licenses/by/4.0/

Bard Brachytherapy, Inc is registered with the FDA (registration 1424526) in Carol Stream, IL, United States. It lists 2 device types. The FDA files 4 510(k) clearances under its listings, the newest dated May 2, 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: 1424526
FEI number: 3002942387
Address: 295 E. Lies RD., Carol Stream, IL, United States, 60188
Owner or operator: C. R. Bard, Inc. (2212754)
Roles: Manufacturer, Specification developer
First device listed: December 16, 1999
Registered through: 2027
Brand names listed: BrachySource Seed Implants, BrachyStar Brachytherapy Needles, BrachyStar Needles, Brachysource Seed Implants with Sourcecap Bioabsorbable Caps, Palladium-103 Seed Implant Kits, QuickLink Delivery System, QuickLink Loader, QuickLink Relay System and more

Devices it lists

Device	Product code	Class	Role	Source
Source, Brachytherapy, Radionuclide	KXK	2	Manufacturer	accessdata.fda.gov
System, Applicator, Radionuclide, Manual	IWJ	1	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
May 2, 2014	K140856	BRACHYSOURCE SEED IMPLANTS WITH SOURCECAP BIOABSORBABLE CAPS	KXK	Substantially Equivalent	C.R. Bard, Inc.	accessdata.fda.gov
December 23, 2009	K093663	RADIONUCLIDE BRACHYTHERAPY SOURCE	KXK	Substantially Equivalent	C.R. Bard, Inc.	accessdata.fda.gov
April 19, 2006	K060636	PALLADIUM-103 SEED IMPLANT KITS -MULTIPLE	KXK	Substantially Equivalent	C.R. Bard, Inc.	accessdata.fda.gov
March 28, 2003	K023210	SEEDLINKS, MODELS 70301, 70302, 70303	KXK	Substantially Equivalent	Sourcetech Medical, LLC	accessdata.fda.gov

Recalls

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

Initiated	Event	Class	Status	Product	Reason	Source
April 10, 2018	79972	Class II	Terminated	BARD BrachySource Iodine125 radioactive seeds consist of a welded titanium capsule containing the I125 absorbed onto a nickel / copper-coated, gold-cored aluminum wire (reference Figure 1 below). The I125 has a half-life	Bard Medical Division is recalling the BARD BrachySource Iodine125 Radioactive Seeds in Mick Applicators and BARD BrachySource Iodine125 Radioactive Seeds Loose in Vial with Sterile Spacers. Because the incorrect dosage level radioactive seeds were mixed up and sent to two hospitals. One Hospital ordered BrachySource Iodine125 0.36 mCi radioactive seeds but	accessdata.fda.gov

Compare with other makers

Updated April 27, 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.