ClearanceBrief
Company

C.R. Bard, Inc., Urological Division

FDA 510(k) clearances and medical device recalls filed under this name. Name variants (Inc, Corp, punctuation) are merged.

0510(k) clearances (0 in 12 months)
13recalls (0 in 12 months)
5recalls that name a 510(k)

Product codes

CodeDeviceRecords
FFLDislodger, Stone, Basket, Ureteral, Metal2
KODCatheter, Urological2
BSYCatheters, Suction, Tracheobronchial1
EXSUrinometer, Electrical1
EZCCatheter, Coude1
EZNDilator, Catheter, Ureteral1
FAQBag, Urine Collection, Leg, For External Use, Sterile1
FPASet, Administration, Intravascular1
GBXCatheter, Irrigation1
KNTTubes, Gastrointestinal (And Accessories)1
MJCCatheter, Urological (Antimicrobial) And Accessories1

Latest 510(k) clearances

Decided510(k)Device and applicantCode
No clearances in this window.

Latest recalls

DateFirm and productCodeLinked 510(k)
Oct 4, 2012C.R. Bard, Inc., Urological Division
8 Fr. Bardex Pediatric All-Silicone Foley Catheter with a 3cc balloon. The product is packaged individually with 12 units per corrugated case. The product is sold sterile for single use and is used
Terminated
KODK821745
Sep 7, 2012C.R. Bard, Inc., Urological Division
Bard Foley procedural trays packaged in breather bags. The product is packaged ten units in each shipper box, and are sold sterile for single use. Used to catheterize patients. The finished trays ar
Terminated
EZCNone listed
Dec 21, 2010C.R. Bard, Inc., Urological Division
Bard CritiCore Monitor, Software Version 2.1, Catalog number 000002N, C.R. Bard, Inc., Covington, GA 30014. Intended for multiple uses as it is an electronic battery-operated monitor used in conjunct
Terminated
EXSNone listed
Nov 26, 2010C.R. Bard, Inc., Urological Division
Bard Rectal Tubes, 22 French, 20 Long (51 cm), X-Ray Opaque Rubber with Funnel end, Open Tip, One Eye , Non sterile, 12 Each, C.R. Bard, Inc., Covington, GA 30014
Terminated
KNTNone listed
Jun 29, 2009C.R. Bard, Inc., Urological Division
Bard StatLock Intravenous (IV) Catheter Stabilization Kit, Catalog number: IVK0124, C.R. Bard, Inc., Covington, GA 30014, USA.
Terminated
FPAK980992
Dec 3, 2005C.R. Bard, Inc., Urological Division
Bard UroForce Balloon Dilation Catheter with Glissando Coating * BARD * C.R. Bard, Inc. Covington, Georgia 30014 * 1-800-526-4455 * Sterile/EO
Terminated
EZNK993840
Nov 23, 2005C.R. Bard, Inc., Urological Division
Bard RespiShield * Closed Suction System with InnoValve * Endotracheal Start Kit * QTY 1 Unit * 14F/4.7mm * Sterile * Rx Only * C.R.Bard, Inc., Covington, GA 30014, 800-526-4455, www. bardmedical.com
Terminated
BSYNone listed
Sep 21, 2005C.R. Bard, Inc., Urological Division
Bard * Davol Reliavac 400 Closed Wound Suction Kit * Sterile/EO * Single use * Medium-Large 3/16'' (15 Fr., 4.7mm) O.D. PVC Drain * 12.5'' (31.7cm) Hole Pattern, X-ray Opaque Stripe Attached Trocar *
Terminated
GBXNone listed
Feb 27, 2004C.R. Bard, Inc., Urological Division
BardiaComplete Foley Kit, Single use only, Do not resterilize, For urological use only, Reorder: 800518, 18 Fr., Lot 76IN0317, Inflate with 10ml sterile water, Contents: 5cc Silicone Elastomer-Coated
Terminated
KODNone listed
Jan 9, 2004C.R. Bard, Inc., Urological Division
Bard Platinum Class II Flat Wire Stone Basket, Ureteral Stone Dislodger, Rx only, Sterile, C.R.Bard, Inc., Covington, GA 30014
Terminated
FFLNone listed
Jan 9, 2004C.R. Bard, Inc., Urological Division
Bard Dimension Stone Basket, Rx only, Sterile, C.R.Bard, Inc., Covington, GA 30014
Terminated
FFLNone listed
Aug 21, 2003C.R. Bard, Inc., Urological Division
Bardex Foley Catheter, 22 Fr 40cc- 20cc Ribbed Balloons, Coleman Model Red Latex, 3 Way Radiopaque, Lubricath Coated, Sterile, Single Use Device, C.R. Bard, Inc., Covington, GA 30014. The catheter is
Terminated
MJCK984136
Apr 17, 2003C.R. Bard, Inc., Urological Division
Bard Dispoz-A-Bag, Disposable Urinary Leg Bags, with Flip-Flo Drainage Valve, 19 oz or 32 oz with a Fabric Leg Strap, C.R.Bard, Inc., Covington, GA 30014, Contents Sterile.
Terminated
FAQK780032
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