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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)
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Top companies in KOD

DateFirm and productCodeLinked 510(k)
Jan 11, 2012Nurse 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
KODK830359
Jan 11, 2012Nurse 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
KODK830359
Jan 11, 2012Nurse 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
KODK830359
Jan 11, 2012Nurse 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
KODK830359
Jan 11, 2012Nurse 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
KODK830359
Jan 11, 2012Nurse 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
KODK830359
Jan 11, 2012Nurse 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
KODK830359
Jan 11, 2012Nurse 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
KODK830359
Jan 11, 2012Nurse 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
KODK830359
Jan 11, 2012Nurse 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
KODK830359
Aug 3, 2011Teleflex 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
KODK896729
Aug 3, 2011Teleflex 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
KODK896729
Aug 3, 2011Teleflex 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
KODK896729
Aug 3, 2011Teleflex 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
KODK896729
Aug 3, 2011Teleflex 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
KODK896729
Aug 3, 2011Teleflex 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
KODK896729
Aug 3, 2011Teleflex 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
KODK896729
Aug 3, 2011Teleflex 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
KODK896729
Aug 3, 2011Teleflex 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
KODK896729
Aug 3, 2011Teleflex 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
KODK896729
Aug 3, 2011Teleflex 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
KODK896729
Aug 3, 2011Teleflex 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
KODK896729
Aug 3, 2011Teleflex 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
KODK896729
May 25, 2011Nurse 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
KODNone listed
May 25, 2011Nurse 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
KODNone listed
May 25, 2011Nurse 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
KODNone listed
May 25, 2011Nurse 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
KODNone listed
May 25, 2011Nurse 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
KODNone listed
May 25, 2011Nurse 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
KODNone listed
May 25, 2011Nurse 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
KODNone listed
May 25, 2011Nurse 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
KODNone listed
May 25, 2011Nurse 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
KODNone listed
May 25, 2011Nurse 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
KODNone listed
May 25, 2011Nurse 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
KODNone listed
May 25, 2011Nurse 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
KODNone listed
May 25, 2011Nurse 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
KODNone listed
May 25, 2011Nurse 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
KODNone listed
May 25, 2011Nurse 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
KODNone listed
May 25, 2011Nurse 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
KODNone listed
May 25, 2011Nurse 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
KODNone listed
May 25, 2011Nurse 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
KODNone listed
Jan 25, 2011Vance 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
KODK820313
Jan 21, 2010Boston 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
KODK011965
Mar 16, 2009Rochester 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
KODK000723
Mar 16, 2009Rochester 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
KODK000723
Mar 16, 2009Rochester 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
KODK000723
Mar 16, 2009Rochester 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
KODK000723
Mar 16, 2009Rochester 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
KODK000723
Mar 16, 2009Rochester 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
KODK000723
Mar 16, 2009Rochester 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
KODK000723

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