Panels › Gastroenterology, Urology › Product code KNX · Class 2
Collector, Urine, (And Accessories) For Indwelling Catheter
Regulation 876.5250
0510(k)s in 12 months (206 all time)
2recalls in 12 months (21 all time)
9recalls that name a 510(k)
Top companies in KNX
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Sep 4, 2026 | C.R. Bard Inc Products that contain the Pericare Wipes:
(Canada Only)
SureStep" Foley Tray System Bardex IC Complete Care
REF: A300314AC
UDI-DI code: 00801741143243
SureStep" Foley Tray System Bardex IC Complete C Open, Classified |
KNX | None listed |
| Sep 4, 2026 | C.R. Bard Inc Products that contain the Pericare Wipes:
SureStep" Foley Tray System Add-A-Foley Catheter
REF: A153200
UDI code: 00801741121067 10801741121064
SureStep" Foley Tray System Complete Care Add-A-Foley Open, Classified |
KNX | None listed |
| Feb 16, 2024 | Cardinal Health 200, LLC Dover URINE METER ADD-A-FOLEY TRAY, 200 ML, NEEDLE SAMPLING PORT, DRAIN TUBE, PREP TRAY; Dover UNIVERSAL TRAY, 1000 ML BASIN, PVP SWAB STICKS, PREPPING COMPONENTS, 30 CC PRE-FILLED SYRINGE; Dover URIN Open, Classified |
KNX | None listed |
| Jan 14, 2019 | Teleflex Medical RUSCH Urinary Drainage bag, 2000mlm REF 390060
urine collection device Terminated |
KNX | None listed |
| Jan 14, 2019 | Teleflex Medical RUSCH CARE Premium Drain bag, 2000mlm REF 390000
urine collection device Terminated |
KNX | None listed |
| Jun 2, 2017 | C.R. Bard, Inc. BARD DISPOZ-A-BAG Leg Bag with Flip-Flo Valve with Drain Extension, Extension Tube and Latex Straps, 19 oz. Packaged as single unit in thermoformed trays. There are 50 units per case.
Product Usa Terminated |
KNX | None listed |
| Jul 11, 2016 | C.R. Bard, Inc. SURESTEP Tray, BARDEX I.C. COMPLETE CARE, Urine Meter, Temperature STATLOCK Stabilization Device Terminated |
KNX | None listed |
| Jun 29, 2016 | C.R. Bard, Inc. SureStep Tray, with Add-a-Foley, COMPLETE CARE, Drainage Bag, and STATLOCK Stabilization
The product is a urine collection system that includes a STATLOCK Foley Stabilization Device Terminated |
KNX | None listed |
| Sep 3, 2015 | Customed, Inc UROLOGY PACK 5/CS
Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
. Terminated |
KNX | None listed |
| Sep 3, 2015 | Customed, Inc UROLOGY PK 5/CS
Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
. Terminated |
KNX | K902886 |
| Sep 3, 2015 | Customed, Inc UROLOGY PK 5/CS
Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
. Terminated |
KNX | K962652 |
| Sep 3, 2015 | Customed, Inc UROLOGY PACK 4/CS
Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
. Terminated |
KNX | K962652 |
| Sep 3, 2015 | Customed, Inc FOLEY CATH KIT 16FR. W/FOLEY S SENSOR 20/CS
Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
. Terminated |
KNX | K962652 |
| Sep 3, 2015 | Customed, Inc UROLOGY CUSTOMED PACK 5/CS
Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
. Terminated |
KNX | K962652 |
| Apr 1, 2015 | C.R. Bard, Inc. Bard 100% Latex-Free Urinary Drainage Bag with Anti-Reflux Chamber and Bard EX-Lok Sampling; Product Code 154006: Lot # NGYJ0603 and NGYJ1671 Terminated |
KNX | None listed |
| Apr 22, 2013 | Teleflex Medical Belly Bag Urine Collection Bag with Hip Belt.
The product is a sterile urine collection device that collects urine by mechanical means when attached to an indwelling Foley or suprapubic catheter. Terminated |
KNX | None listed |
| May 27, 2011 | Covidien LP URI-DRAIN Male Urinary Control Device - Large
Product ID: 8884732598 (sold in Canada only)
Intended use:Collector urine from male patients (and accessories) for indwelling catheter Terminated |
KNX | K770789 |
| May 27, 2011 | Covidien LP URI-DRAIN Standard Male External Catheter with Two-Sided Adhesive Strap and Skin Protective Wipe
Product ID: 8884732500
Intended use: Collector urine from male patients (and accessories) for indwelli Terminated |
KNX | K770789 |
| May 27, 2011 | Covidien LP URI-DRAIN Medium Male External Catheter With Two-Sided Adhesive Strap and Skin Protective Wipe
Product ID: 8884732000
Intended use: Collector urine from male patients (and accessories) for indwelling Terminated |
KNX | K770789 |
| Mar 23, 2005 | Teleflex Medical, Inc. Latex Free*** REF B1000P Belly Bag Urine Collection Bag with Sample Port***1000 ml LOT***Sterile EO*** Single use only, Manufactured and Distributed by***Rusch Inc., 245 Meadowbrook Parkway, Duluth, G Terminated |
KNX | None listed |
| Mar 23, 2005 | Teleflex Medical, Inc. Latex-Free REF B1000, Belly Bag Urine Collection Bag with Hip Belt, ***1000 ml Lot***Sterile EO***Manufactured and Distributed by***Rusch Inc. 245 Meadowbrook Parkway, Duluth, GA 30096***Quantity 1 Terminated |
KNX | K871387 |
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