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
| Code | Device | Records |
|---|---|---|
| FFL | Dislodger, Stone, Basket, Ureteral, Metal | 2 |
| KOD | Catheter, Urological | 2 |
| BSY | Catheters, Suction, Tracheobronchial | 1 |
| EXS | Urinometer, Electrical | 1 |
| EZC | Catheter, Coude | 1 |
| EZN | Dilator, Catheter, Ureteral | 1 |
| FAQ | Bag, Urine Collection, Leg, For External Use, Sterile | 1 |
| FPA | Set, Administration, Intravascular | 1 |
| GBX | Catheter, Irrigation | 1 |
| KNT | Tubes, Gastrointestinal (And Accessories) | 1 |
| MJC | Catheter, Urological (Antimicrobial) And Accessories | 1 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| No clearances in this window. | |||
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Oct 4, 2012 | C.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 |
KOD | K821745 |
| Sep 7, 2012 | C.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 |
EZC | None listed |
| Dec 21, 2010 | C.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 |
EXS | None listed |
| Nov 26, 2010 | C.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 |
KNT | None listed |
| Jun 29, 2009 | C.R. Bard, Inc., Urological Division Bard StatLock Intravenous (IV) Catheter Stabilization Kit, Catalog number: IVK0124, C.R. Bard, Inc., Covington, GA 30014, USA. Terminated |
FPA | K980992 |
| Dec 3, 2005 | C.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 |
EZN | K993840 |
| Nov 23, 2005 | C.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 |
BSY | None listed |
| Sep 21, 2005 | C.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 |
GBX | None listed |
| Feb 27, 2004 | C.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 |
KOD | None listed |
| Jan 9, 2004 | C.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 |
FFL | None listed |
| Jan 9, 2004 | C.R. Bard, Inc., Urological Division Bard Dimension Stone Basket, Rx only, Sterile, C.R.Bard, Inc., Covington, GA 30014 Terminated |
FFL | None listed |
| Aug 21, 2003 | C.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 |
MJC | K984136 |
| Apr 17, 2003 | C.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 |
FAQ | K780032 |