ClearanceBrief
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)
Get daily alerts for KODSample briefCSV

Top companies in KOD

DateFirm and productCodeLinked 510(k)
Sep 4, 2026C.R. Bard Inc
Products that contain the Pericare Wipes: SureStep Intermittent Catheter Tray REF: INTP16 INTS14 INTS14C INTS16 INTS16C PEDINTS06 PEDINTS08 PEDINTS10 UDI code: 00801741183300 10801741183307 008017411
Open, Classified
KODK000723
K802665
Jul 3, 2025C.R. Bard Inc
BD Heyman Follower Coude Tip for following sizes: 12Fr - REF:021312 14Fr - REF:021314, 16Fr - REF: 021316
Open, Classified
KODNone listed
Jul 3, 2025C.R. Bard Inc
BD Heyman Follower Straight Tip for following sizes: 10Fr - REF:21110, 12Fr - REF:21112, 14Fr - REF: 21114, 20Fr - REF: 21120
Open, Classified
KODNone listed
Feb 16, 2024Cardinal Health 200, LLC
Dover" 100% SILICONE FOLEY TRAY, NEEDLELESS, 14 FR (4.7 MM), 5 CC, 2000 ML DRAIN BAG, DRAIN SPOUT; Dover" HYDROGEL COATED LATEX FOLEY CATHETER KIT, 5 CC, 2-WAY, 14 FR (4.7 MM), 10 CC WATER SYRINGE
Open, Classified
KODK860484
Nov 11, 2022TELEFLEX LLC
Teleflex Medical RUSCH Pocket Pac i.c. Closed System Intermittent Catheter Kit, 14 Fr (4.7mm), REF 10096140 (IPN050116). Urinary catheter.
Open, Classified
KODK010420
Jan 27, 2022C.R. Bard Inc
BARD SURESTEP INTERMITTENT CATHETER TRAY, 14Fr, REF INTS16C
Terminated
KODK000723
Jan 27, 2022C.R. Bard Inc
BARD SURESTEP INTERMITTENT CATHETER TRAY, 14Fr, REF INTS14C
Terminated
KODK000723
Jan 11, 2021C.R. Bard, Inc.
Bard Clean-Cath Intermittent Catheter, 12 French female length (catheter, urological) - Product Usage: for urological use only.
Terminated
KODK802665
Apr 30, 2020Covidien Llc
Dover 400 ml 100% Silicone Silver-Hydrogel Coated Premium Urine Meter Foley Tray, 18 Fr/Ch (6.0 mm), 5 mL Catheter Pre-connected to 2000 mL Drainage Bag with Luer-Lock Sampling, Temperature Sensor and
Terminated
KODK933400
Apr 30, 2020Covidien Llc
Dover 400 ml 100% Silicone Silver-Hydrogel Coated Premium Urine Meter Foley Tray,18 Fr/Ch (6.0 mm), 5 mL Catheter Pre-connected to 2000 mL Drainage Bag with Temperature Sensor, Sterile, Product Code:
Terminated
KODK933400
Apr 30, 2020Covidien Llc
Dover 100% Silicone Silver-Hydrogel Coated Premium Urine Meter Foley Tray 400mL, 16 Fr/Ch (5.3 mm), 5 mL Catheter Pre-connected to 2000 mL Drainage Bag with Luer-Lock Sampling, Temperature Sensor and
Terminated
KODK933400
Apr 30, 2020Covidien Llc
Dover 100% Silicone Silver-Hydrogel Coated Premium Urine Meter Foley Tray 400mL, Premium, Urine Meter, 16 Fr/Ch (5.3 mm), 5 mL Catheter Pre-connected to 2000 mL Drainage Bag with Luer-Lock Sampling, T
Terminated
KODK933400
Apr 30, 2020Covidien Llc
Dover 400mL, 100% Silicone Premium Urine Meter Foley Tray, 16 Fr/Ch (5.3 mm), 5 mL Catheter Pre-connected to 2000 mL Drainage Bag with Luer-Lock Sampling, Temperature Sensor and Adhesive Catheter Sec
Terminated
KODK933400
Apr 30, 2020Covidien Llc
Dover 100% Silicone Premium Urine Meter Tray 400mL, 16 Fr/Ch (5.3 mm), 5 mL Foley Catheter Pre-connected to 2000 mL Drainage Bag with Temperature Sensor, Sterile, Product Code: P4P16TS - Product Usage
Terminated
KODK933400
Apr 30, 2020Covidien Llc
Dover 100% Silicone Premium Urine Meter Foley Tray, 400mL, 14 Fr/Ch (4.7 mm), 5 mL Catheter Pre-connected to 2000 mL Drainage Bag with Luer-Lock Sampling, Temperature Sensor and Adhesive Catheter Secu
Terminated
KODK933400
Apr 30, 2020Covidien Llc
Dover 100% Silicone Silver-Hydrogel Coated Foley Catheter with Temperature Sensor 18FR 5CCCC2W, Product Code: 50518ICT - Product Usage: for Drainage of the Urinary bladder and simultaneous monitoring
Terminated
KODK933400
Apr 30, 2020Covidien Llc
Dover 100% Silicone Foley Catheter with Temperature 16FR 5CC2W, Product Code: 50516T - Product Usage: for Drainage of the Urinary bladder and simultaneous monitoring of temperature. Prescription use
Terminated
KODK933400
Apr 30, 2020Covidien Llc
Dover 100% Silicone Silver-Hydrogel Coated Foley Catheter with Temperature Sensor 16FR 5CCCC2W, Product Code: 50516ICT - Product Usage: for Drainage of the Urinary bladder and simultaneous monitoring
Terminated
KODK933400
Apr 30, 2020Covidien Llc
Dover 100% Silicone Foley Catheter with Temperature Sensor 14FR 5CC2W, Product Code: 50514T - Product Usage: for Drainage of the Urinary bladder and simultaneous monitoring of temperature. Prescriptio
Terminated
KODK933400
Jul 1, 2019Teleflex Medical
Rusch EasyCath Kit
Terminated
KODK000070
Jan 9, 2019ConvaTec, Inc
Nelaton Urinary Catheter, disposable, sterile, 100 eaches per sales unit. Labeled as: CH16/40CM and CH14/40CM Product Usage: Urinary Catheters are sterile disposable devices intended to provide an in
Open, Classified
KODK896729
Jul 11, 2018COVIDIEN LLC
P400 PREM U/M 16FR TMPSNS, Item Code P4P16TS
Terminated
KODK933400
Jul 11, 2018COVIDIEN LLC
P400 PREM U/M 18FR TMPSNS, Item Code P4P18TS
Terminated
KODK933400
Jul 11, 2018COVIDIEN LLC
400mL, Premium, Urine Meter, 16 FR, Silicone Temperature Sensing Foley Traywith Cath-Secure Plus, Sterile, Item Code P4P16TSD
Terminated
KODK933400
Jul 11, 2018COVIDIEN LLC
400mL, Premium, Urine Meter, 14 FR, Silicone Temperature Sensing Foley Traywith Cath-Secure Plus, Sterile, Item Code P4P14TSD
Terminated
KODK933400
Jul 11, 2018COVIDIEN LLC
TEMP SENSE SILICONE 14FR5CC2W, Item Code 50514T
Terminated
KODK933400
Jul 11, 2018COVIDIEN LLC
400mL, Premium, Urine Meter, 16 FR, Silicone Temperature Sensing Foley Traywith Cath-Secure Plus, Sterile, Item Code P4P16XTSD
Terminated
KODK933400
Nov 22, 2016Teleflex Medical
RUSCH, Pocket PAC IC Intermittent Cath Kit, 8 FR, 12 FR, 14 FR, 10 FR and 16 FR, Rx Only, Sterile, Intermittent self-catheterization
Terminated
KODK010420
Sep 3, 2015C.R. Bard, Inc.
Magic3 Intermittent Catheter with Sure Grip Hydrophilic Coated Silicone Coude tip, Product Code 50614. The catheters are packaged in film-to-film pouches and packaged 30 per box. Used as an Intermitt
Terminated
KODK000723
Aug 14, 2015C.R. Bard, Inc.
Magic3 Hydrophilic-coated Female Intermittent Urinary Catheter 14 Fr in the Insertion Supply Kit, Product Code 51614S. Intermittent catheter.
Terminated
KODK000723
Aug 14, 2015C.R. Bard, Inc.
Magic3 Hydrophilic-coated Female Intermittent Urinary Catheters (6"), 16 Fr, (30/box), Product Code 51616. Intermittent catheter.
Terminated
KODK000723
Aug 14, 2015C.R. Bard, Inc.
Magic3 Hydrophilic-coated Female Intermittent Urinary Catheters (6"), 14 Fr, (30/box), Product Code 51614. Intermittent catheter.
Terminated
KODK000723
Aug 14, 2015C.R. Bard, Inc.
Magic3 Hydrophilic-coated Female Intermittent Urinary Catheters (6"), 12 Fr, (30/box), Product Code 51612. Intermittent catheter.
Terminated
KODK000723
Aug 14, 2015C.R. Bard, Inc.
Magic3 Hydrophilic-coated Female Intermittent Urinary Catheters (6"), 10 Fr, (30/box), Product Code 51610. Intermittent catheter.
Terminated
KODK000723
Sep 18, 2014Teleflex Medical
Rusch, Soft Rubber (Nelaton and Nelaton Robinson), Bladder Catheter, Sterile. These catheters are indicated for the routine drainage of urine from the bladder. These catheters are not intended or des
Terminated
KODNone listed
Jun 9, 2014Teleflex Medical
RUSCH Easy Cath Coude Kit, 10 FR, Rx Only, Sterile, Distributed by: Teleflex Medical, Research Triangle Park, NC 27708. A tubular device that is inserted through the urethera and is used to pass flui
Terminated
KODK000070
Mar 20, 2014Convatec Inc.
SLC 3-way standard Lubricious Coated 20Ch/Fr 30 mL/cc Product Usage: Latex Lubricous Coated Foley Catheters The standard catheter essentially consists of a flexible lubricous coated latex tube which
Terminated
KODNone listed
Mar 20, 2014Convatec Inc.
'TORAY' Hydrocoat Foley Catheter 12 x10 4.00 mm Fr x mL Product Usage: Latex Lubricous Coated Foley Catheters The standard catheter essentially consists of a flexible lubricous coated latex tube whic
Terminated
KODNone listed
Mar 20, 2014Convatec Inc.
JMS, Japan, 3 WAY, 20 FR 10 mL Product Usage: Latex Lubricous Coated Foley Catheters The standard catheter essentially consists of a flexible lubricous coated latex tube which incorporates one majo
Terminated
KODNone listed
Mar 20, 2014Convatec Inc.
SLC 2-way standard Lubricious Coated 14ch/FR 5/10ml/cc Product Usage: Usage: Latex Lubricous Coated Foley Catheters The standard catheter essentially consists of a flexible lubricous coated latex tu
Terminated
KODNone listed
Mar 20, 2014Convatec Inc.
Curion CuriStay Nelaton CH - 14 2-W Hydrogel Coated (Latex) 5- 10 mL Product Usage: Latex Lubricous Coated Foley Catheters The standard catheter essentially consists of a flexible lubricous coated
Terminated
KODNone listed
Mar 20, 2014Convatec Inc.
Medline Sterile Foley Catheter 14 fr 5 cc 12 pieces model number DNYD11914 Product Usage:Latex Lubricous Coated Foley Catheters The standard catheter essentially consists of a flexible lubricous c
Terminated
KODNone listed
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
Apr 11, 2012Boston Scientific Corporation
Boston Scientific, IMAGER II Urology Torque Catheter, Sterilized with ethylene oxide gas. Made in Ireland, Manufactured for Boston Scientific Corporation, One Boston Scientific Place, Natick, MA 01760
Terminated
KODK011965
K102527
Jan 11, 2012Nurse Assist, Inc
REF UT8150 Urethal Insertion Tray 14Fr Red Rubber Catheter with PVP Swabs Qty: 20 For Rx Only Sterile unless package is damaged or opened. Latex Free Manufactured for: Coloplast A/S 3050 Denmark STERI
Terminated
KODK830359
Jan 11, 2012Nurse Assist, Inc
REF UT8140 Urethal Insertion Tray Qty: 20 For Rx Only Sterile unless package is damaged or opened. Latex Free Manufactured for: Coloplast A/S 3050 Denmark STERILE EO Distributed by: Coloplast Corp. Mi
Terminated
KODK830359
Jan 11, 2012Nurse Assist, Inc
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 Manufactured for: Coloplast A/S 3050 Denmark STERI
Terminated
KODK830359
Jan 11, 2012Nurse Assist, Inc
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 Manufactured for: Coloplast A/S 3050 Denmark STERI
Terminated
KODK830359
Jan 11, 2012Nurse Assist, Inc
WELCON TM BRAND REORDER NO. 8012 (STERILE) CATHETER CARE KIT 60 ea/Box nurse assist incorporated 800-649-6800 3400 Northern Cross Blvd. Fort Worth, TX 76137 www.nurseassist.com CATHETER CARE KIT
Terminated
KODK830359
Jan 11, 2012Nurse Assist, Inc
WELCON TM BRAND REORDER NO. 7402 (STERILE) URETHRAL CATHETER KIT (Female) 25 ea/Box nurse assist incorporated 800-649-6800 3400 Northern Cross Blvd. Fort Worth, TX 76137 www.nurseassist.com URETHRAL
Terminated
KODK830359

Free CSV: newest 100 rows. Paid plans export up to 1,000 or 10,000 rows.