Panels › Gastroenterology, Urology › Product code KOD · Class 2
Catheter, Urological
Regulation 876.5130
1510(k)s in 12 months (238 all time)
1recalls in 12 months (108 all time)
80recalls that name a 510(k)
Top companies in KOD
| Company | 510(k)s | Recalls |
|---|---|---|
| Nurse Assist, Inc | 0 | 34 |
| C.R. Bard, Inc. | 10 | 12 |
| COVIDIEN LLC | 0 | 17 |
| Teleflex Medical | 0 | 17 |
| Rochester Medical Corp. | 2 | 14 |
| Convatec Limited | 3 | 7 |
| Abco Dealers, Inc. | 9 | 0 |
| Van-Tec, Inc. | 8 | 0 |
| Boston Scientific Corp | 5 | 2 |
| The Kendal Co. | 7 | 0 |
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jan 11, 2012 | Nurse Assist, Inc WELCON TM BRAND REORDER NO. 7401 (STERILE) URETHRAL CATHETER KIT With 3 Compartment Plastic Pouch. LOT 25 ea/Box nurse assist incorporated 800-649-6800 3400 Northern Cross Blvd. Fort Worth, TX 76137 w Terminated |
KOD | K830359 |
| Jan 11, 2012 | Nurse Assist, Inc WELCON TM BRAND REORDER NO. 7305 (STERILE) FOLEY CATHETER TRAY w/o Catheter w/10ml. Prefilled Syringe 20 ea/Box nurse assist incorporated 800-649-6800 3400 Northern Cross Blvd. Fort Worth, TX 76137 ww Terminated |
KOD | K830359 |
| Jan 11, 2012 | Nurse Assist, Inc WELCON TM BRAND REORDER NO. 7304 (STERILE) FOLEY CATHETER TRAY w/o Catheter w/30ml. Prefilled Syringe 20 ea/Box nurse assist incorporated 800-649-6800 3400 Northern Cross Blvd. Fort Worth, TX 76137 ww Terminated |
KOD | K830359 |
| Jan 11, 2012 | Nurse Assist, Inc WELCON TM BRAND REORDER NO. 7303 (STERILE) FOLEY CATHETER TRAY w/o Catheter w/10ml. Prefilled Syringe 20 ea/Box nurse assist incorporated 800-649-6800 3400 Northern Cross Blvd. Fort Worth, TX 76137 ww Terminated |
KOD | K830359 |
| Jan 11, 2012 | Nurse Assist, Inc WELCON TM BRAND REORDER NO. 7302 (STERILE) URETHRAL CATHETER TRAY w/ Red Rubber Catheter Caution: Contains Natural Latex 20 ea/Box nurse assist incorporated 800-649-6800 3400 Northern Cross Blvd. Fort Terminated |
KOD | K830359 |
| Jan 11, 2012 | Nurse Assist, Inc WELCON TM BRAND REORDER NO. 7301 (STERILE) URETHRAL CATHETER TRAY w/ Plastic Catheter 20 ea/Box nurse assist incorporated 800-649-6800 3400 Northern Cross Blvd. Fort Worth, TX 76137 www.nurseassist.co Terminated |
KOD | K830359 |
| Jan 11, 2012 | Nurse Assist, Inc WELCON TM BRAND REORDER NO. 7300 (STERILE) URETHRAL CATHETER TRAY w/o Plastic Catheter 20 ea/Box nurse assist incorporated 800-649-6800 3400 Northern Cross Blvd. Fort Worth, TX 76137 www.nurseassist.c Terminated |
KOD | K830359 |
| Jan 11, 2012 | Nurse Assist, Inc McKESSON Medi-Pak Foley Catheter Tray without Catheter For Use With 30 cc Foley Catheter Sterile.Single Use.Disposable.Latex-Free 20 Trays Per Case Reorder No. 37-234 Marketed by McKesson Corporation Terminated |
KOD | K830359 |
| Jan 11, 2012 | Nurse Assist, Inc McKESSON Medi-Pak Urethral Catheter Tray with Red Rubber Catheter Sterile.Single Use.Disposable 20 Trays Per Case Reorder No. 37-232 CAUTION: THIS PRODUCT CONTAINS NATURAL RUBBER LATEX WHICH MAY CAUSE Terminated |
KOD | K830359 |
| Jan 11, 2012 | Nurse Assist, Inc McKESSON Medi-Pak Urethral Catheter Tray with Plastic Catheter Sterile.Single Use.Disposable.Latex-Free 20 Trays Per Case Reorder No. 37-231 Marketed by McKesson Corporation McKesson Medical-Surgical, Terminated |
KOD | K830359 |
| Aug 3, 2011 | Teleflex Medical RUSCH, GB: Robinson/Nelaton Catheter, All Purpose PVC 40 Fr. 40 cm, Distributed by Teleflex Medical, Research Triangle Park, NC.
Product Usage: Catheter that is inserted through the urethra and used Terminated |
KOD | K896729 |
| Aug 3, 2011 | Teleflex Medical RUSCH, GB: Robinson/Nelaton Catheter, All Purpose PVC 22 Fr. 40 cm, Distributed by Teleflex Medical, Research Triangle Park, NC.
Product Usage: Catheter that is inserted through the urethra and used Terminated |
KOD | K896729 |
| Aug 3, 2011 | Teleflex Medical RUSCH, GB: Robinson/Nelaton Catheter, All Purpose PVC 20 Fr. 40 cm, Distributed by Teleflex Medical, Research Triangle Park, NC
Product Usage: Catheter that is inserted through the urethra and used t Terminated |
KOD | K896729 |
| Aug 3, 2011 | Teleflex Medical RUSCH, GB: Robinson/Nelaton Catheter, All Purpose PVC 18 Fr. 40 cm, Distributed by Teleflex Medical, Research Triangle Park, NC.
Product Usage: Catheter that is inserted through the urethra and used Terminated |
KOD | K896729 |
| Aug 3, 2011 | Teleflex Medical RUSCH, GB: Robinson/Nelaton Catheter, All Purpose PVC 16 Fr. 40 cm, Distributed by Teleflex Medical, Research Triangle Park, NC.
Product Usage: Catheter that is inserted through the urethra and used Terminated |
KOD | K896729 |
| Aug 3, 2011 | Teleflex Medical RUSCH, GB: Robinson/Nelaton Catheter, All Purpose PVC 14 Fr. 40 cm, Distributed by Teleflex Medical, Research Triangle Park, NC
Product Usage: Catheter that is inserted through the urethra and used t Terminated |
KOD | K896729 |
| Aug 3, 2011 | Teleflex Medical RUSCH, GB: Robinson/Nelaton Catheter, All Purpose PVC 12 Fr. 40 cm, Distributed by Teleflex Medical, Research Triangle Park, NC.
Product Usage: Catheter that is inserted through the urethra and used Terminated |
KOD | K896729 |
| Aug 3, 2011 | Teleflex Medical RUSCH, GB: Robinson/Nelaton Catheter, All Purpose PVC 10 Fr. 40 cm, Distributed by Teleflex Medical, Research Triangle Park, NC
Product Usage: Catheter that is inserted through the urethra and used t Terminated |
KOD | K896729 |
| Aug 3, 2011 | Teleflex Medical RUSCH, GB: Female Catheter, All Purpose PVC, 16 Fr. 18 cm, Distributed by Teleflex Medical, Research Triangle Park, NC
Product Usage: Catheter that is inserted through the urethra and used to pass fl Terminated |
KOD | K896729 |
| Aug 3, 2011 | Teleflex Medical RUSCH, GB: Female Catheter, All Purpose PVC, 14 Fr. 18 cm, Distributed by Teleflex Medical, Research Triangle Park, NC
Product Usage: Catheter that is inserted through the urethra and used to pass fl Terminated |
KOD | K896729 |
| Aug 3, 2011 | Teleflex Medical RUSCH, GB: Female Catheter, All Purpose PVC, 12 Fr. 18 cm, Distributed by Teleflex Medical, Research Triangle Park, NC
Product Usage: Catheter that is inserted through the urethra and used to pass fl Terminated |
KOD | K896729 |
| Aug 3, 2011 | Teleflex Medical RUSCH, GB: Female Catheter, All Purpose PVC, 10 Fr. 18 cm, Distributed by Teleflex Medical, Research Triangle Park, NC
Product Usage: Catheter that is inserted through the urethra and used to pass fl Terminated |
KOD | K896729 |
| Aug 3, 2011 | Teleflex Medical RUSCH, GB: Female Catheter, All Purpose PVC, 08 Fr. 18 cm, Distributed by Teleflex Medical, Research Triangle Park, NC
Product Usage: Catheter that is inserted through the urethra and used to pass fl Terminated |
KOD | K896729 |
| May 25, 2011 | Nurse Assist, Inc Case Label: REF UT7035 Catheter Insertion Tray 30cc Pre-Filled Syringe with BZK Swabs Qty: 20 For Rx Only Sterile unless package is damaged or opened. Latex Free STERILE EO Distributed by: Colopla Terminated |
KOD | None listed |
| May 25, 2011 | Nurse Assist, Inc Case Label: REF UT7030 Catheter Insertion Tray 30cc Pre-Filled Syringe with PVP Swabs Qty: 20 For Rx Only Sterile unless package is damaged or opened. Latex Free STERILE EO Distributed by: Coloplas Terminated |
KOD | None listed |
| May 25, 2011 | Nurse Assist, Inc Case Label: REF UT7015 Catheter Insertion Tray 10cc Pre-Filled Syringe with BZK Swabs Qty: 20 For Rx Only Sterile unless package is damaged or opened. Latex Free STERILE EO Distributed by: Coloplas Terminated |
KOD | None listed |
| May 25, 2011 | Nurse Assist, Inc Case Label: REF UT7010 Catheter Insertion Tray 10cc Pre-Filled Syringe with PVP Swabs Qty: 20 For Rx Only Sterile unless package is damaged or opened. Latex Free STERILE EO Manufactured for: Colop Terminated |
KOD | None listed |
| May 25, 2011 | Nurse Assist, Inc Case Label: REORDER NO. 7304 (STERILE) WELCON BRAND FOLEY CATHETER TRAY w/o Catheter w/30ml. Prefilled Syringe nurse assist incorporated 20 ea/Box 800-649-6800 3400 Northern Cross Blvd. Fort Worth, Terminated |
KOD | None listed |
| May 25, 2011 | Nurse Assist, Inc Case Label: REORDER NO. 7303 (STERILE) WELCON BRAND FOLEY CATHETER TRAY w/o Catheter w/10ml. Prefilled Syringe nurse assist incorporated 20 ea/Box 800-649-6800 3400 Northern Cross Blvd. Fort Worth, T Terminated |
KOD | None listed |
| May 25, 2011 | Nurse Assist, Inc Case Label: REORDER NO. 7302 (STERILE) WELCON BRAND URETHRAL CATHETER TRAY w/Red Rubber Catheter Caution: Contains Natural Latex nurse assist incorporated 20 ea/Box 800-649-6800 3400 Northern Cross Terminated |
KOD | None listed |
| May 25, 2011 | Nurse Assist, Inc Case Label: REORDER NO. 7301 (STERILE) WELCON BRAND URETHRAL CATHETER TRAY w/ Plastic Catheter nurse assist incorporated 20 ea/Box 800-649-6800 3400 Northern Cross Blvd. Fort Worth, TX 76137 www.nurs Terminated |
KOD | None listed |
| May 25, 2011 | Nurse Assist, Inc Case Label: REORDER NO. 7300 (STERILE) WELCON BRAND URETHRAL CATHETER TRAP w/o Plastic Catheter nurse assist incorporated 20 ea/Box 800-649-6800 3400 Northern Cross Blvd. Fort Worth, TX 76137 www.nur Terminated |
KOD | None listed |
| May 25, 2011 | Nurse Assist, Inc Case Label: REORDER NO. 7204 (STERILE) CSR WRAP WELCON BRAND FOLEY CATHETER TRAY w/o Catheter w/30ml. Prefilled Syringe nurse assist incorporated 20 ex/Box 800-649-6800 3400 Northern Cross Blvd. Fort Terminated |
KOD | None listed |
| May 25, 2011 | Nurse Assist, Inc Case Label: REORDER NO. 7203 (STERILE) CSR WRAP WELCON BRAND FOLEY CATHETER TRAY w/o Catheter w/10ml. Prefilled Syringe 20 ea/Box 800-649-6800 3400 Northern Cross Blvd. Fort Worth, TX 76137 www.nurse Terminated |
KOD | None listed |
| May 25, 2011 | Nurse Assist, Inc Case Label: REORDER NO. 7202 (STERILE) CSR WRAP WELCON BRAND URETHRAL CATHETER TRAY with 14 french red rubber catheter Caution: Contains Natural Latex nurse assist incorporated 20 ea/Box 800-649-680 Terminated |
KOD | None listed |
| May 25, 2011 | Nurse Assist, Inc Case Label: REORDER NO. 7201 (STERILE) CSR WRAP WELCON BRAND URETHRAL CATHETER TRAY w/ Plastic Catheter anureses assist incorporated 20 ea/Box 800-649-6800 3400 Northern Cross Blvd. Fort Worth, TX 76 Terminated |
KOD | None listed |
| May 25, 2011 | Nurse Assist, Inc Case Label: REORDER NO. 7200 (STERILE) CSR WRAP WELCON BRAND URETHRAL CATHETER TRAY w/o Catheter nurse assist incorporated 20 ex/Box 800-649-6800 3400 Northern Cross Blvd. Fort Worth, TX 76137 www.nu Terminated |
KOD | None listed |
| May 25, 2011 | Nurse Assist, Inc Case Label: McKESSON Medi-Pak LATEX FREE Foley Catheter Tray Without Catheter For Use With 30 cc Foley Catheter Sterile Single Use Disposable Latex-Free 20 Trays Per Case Reorder No. 37-234 Marketed Terminated |
KOD | None listed |
| May 25, 2011 | Nurse Assist, Inc Case Label: McKESSON Medi-Pak Ureteral Catheter Tray With Red Rubber Catheter Sterile Single Use Disposable 20 Trays Per Case Reorder No. 37-232 Marketed By McKesson Corporation McKesson Medical-Surg Terminated |
KOD | None listed |
| May 25, 2011 | Nurse Assist, Inc Case Label: McKESSON Medi-Pak Urethral Catheter Tray With Plastic Catheter Sterile Single Use Disposable Latex-Free 20 Trays Per Case Reorder No. 37-231 Marketed By McKesson Corporation McKesson Medi Terminated |
KOD | None listed |
| May 25, 2011 | Nurse Assist, Inc Case Label: McKESSON Medi-Pak Uretheral Catheter Tray With Red Rubber Catheter Sterile Single Use Disposable 20 Trays Per Case Reorder No. 37-202 Marketed By McKesson Corporation McKesson Medical-Sur Terminated |
KOD | None listed |
| Jan 25, 2011 | Vance Products Inc. dba Cook Urological Inc. & Cook OB/GYN Cook Urological, Inc. Koyle Diaper Stent 6.0 Fr, Sterile, GPN G17667, REF KDSCF-060050. Terminated |
KOD | K820313 |
| Jan 21, 2010 | Boston Scientific Corporation Imager" II Urology Torque Catheter, Sterilized with ethylene oxide gas, Manufactured for Boston Scientific Corporation, One Boston scientific Place, Natick, MA 01760-1537, USA, Made in Ireland, Unit 7 Terminated |
KOD | K011965 |
| Mar 16, 2009 | Rochester Medical Corp HydroSil (Intermittent Catheter) Hydrophilic 14 French Male Length REF#63614
Rochester Medical, Distributed by Rochester Medical Ltd 10 Commerce Way, Lancing West Sussex BN158TA, Sterile R, Rochester Terminated |
KOD | K000723 |
| Mar 16, 2009 | Rochester Medical Corp HydroSil (Intermittent Catheter), Hydrophilic 12 French Male Length REF#63612
Rochester Medical, Distributed by Rochester Medical Ltd 10 Commerce Way, Lancing West Sussex BN158TA, Sterile R, Rocheste Terminated |
KOD | K000723 |
| Mar 16, 2009 | Rochester Medical Corp HydroSil (Intermittent Catheter), Hydrophilic 14 French Male Length Sample Packs REF#63614SPL
Rochester Medical, Distributed by Rochester Medical Ltd 10 Commerce Way, Lancing West Sussex BN158TA, Ste Terminated |
KOD | K000723 |
| Mar 16, 2009 | Rochester Medical Corp HydroSil (Intermittent Urethral Catheter), Hydrophilic 12 French Male Length Sample Packs REF#63612SPL
Rochester Medical, Distributed by Rochester Medical Ltd 10 Commerce Way, Lancing West Sussex BN1 Terminated |
KOD | K000723 |
| Mar 16, 2009 | Rochester Medical Corp Magic3 (Intermittent Catheter), Sterile. Hydrophilic 16 French Male Length REF 53616
Rochester Medical, Rochester Medical Corporation, Stewartville, MN 55976.
Intended for use for bladder managemen Terminated |
KOD | K000723 |
| Mar 16, 2009 | Rochester Medical Corp Magic3 (Intermittent Catheter), Sterile. Hydrophilic 14 French Male Length REF 53614
Rochester Medical, Rochester Medical Corporation, Stewartville, MN 55976.
Intended for use for bladder managemen Terminated |
KOD | K000723 |
| Mar 16, 2009 | Rochester Medical Corp Magic3 (Intermittent Catheter), Sterile. Hydrophilic 12 French Male Length REF 53612
Rochester Medical, Rochester Medical Corporation, Stewartville, MN 55976.
Intended for use for bladder managemen Terminated |
KOD | K000723 |
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