ClearanceBrief
Panels › Gastroenterology, Urology › Product code FCM · Class 2

Tray, Catheterization, Sterile Urethral, With Or Without Catheter (Kit)

Regulation 876.5130

1510(k)s in 12 months (60 all time)
0recalls in 12 months (43 all time)
16recalls that name a 510(k)
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Top companies in FCM

DateFirm and productCodeLinked 510(k)
Sep 6, 2024MEDLINE INDUSTRIES, LP - Northfield
Medline Convenience kits labeled as: 1) URETEROSCOPY CDS SC-LF, Pack Number CDS983922F ; 2) URETEROSCOPY TRAY-RF, Pack Number DYNJ27442U ; 3) URETHROPLASTY PACK, Pack Number DYNJ39700B ; 4) RRP P
Open, Classified
FCMNone listed
Feb 16, 2024Cardinal Health 200, LLC
Dover" 100% SILICONE 400 ML U/M FOLEY TRAY, NEEDLE PORT, 16 FR (5.3 MM), 5 CC, 2000 ML DRAIN BAG; Dover" HYDROGEL COATED LATEX 400 ML U/M FOLEY TRAY, NEEDLE, 16 FR (5.3 MM), 5 CC, 2000 ML BAG; Dover"
Open, Classified
FCMK903340
Aug 3, 2023MEDLINE INDUSTRIES, LP - Northfield
Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound Gel. Labeled as the following: a. LIVER 2018, Model Number: DYNJ905655A;
Open, Classified
FCMNone listed
Dec 2, 2022Cardinal Health
Dover Closed Urethral Tray with Vinyl Catheter 14 Fr/Ch (4.7 mm), 5 mL Catheter Pre-connected to 1000 mL Drainage Bag Product Code: 3450LF Intended for urinary drainage from the bladder of a patient.
Open, Classified
FCMK903340
Dec 2, 2022Cardinal Health
Dover Closed Urethral Tray with Vinyl Catheter 14 Fr/Ch (4.7 mm), 5 mL Catheter Pre-connected to 1000 mL Drainage Bag Product Code: 3450 Intended for urinary drainage from the bladder of a patient
Open, Classified
FCMK903340
Dec 2, 2022Cardinal Health
Dover Closed Urethral Tray with Vinyl Catheter Product Code: 3420 Intended for urinary drainage from the bladder of a patient
Open, Classified
FCMK903340
Dec 2, 2022Cardinal Health
Dover Closed Urethral Tray with Hydrogel Coated Red Rubber Catheter 14 Fr/Ch (4.7 mm) Product Code: 3410 Intended for urinary drainage from the bladder of a patient
Open, Classified
FCMK903340
Dec 2, 2022Cardinal Health
Dover Closed Urethral Tray with Hydrogel Coated Red Rubber Catheter 16 Fr/Ch (5.3 mm) Product Code: 3408 Intended for urinary drainage from the bladder of a patient
Open, Classified
FCMK903340
Dec 2, 2022Cardinal Health
Dover Closed Urethral Tray with Vinyl Catheter 14 Fr/Ch (4.7 ml) 5ml Catheter Product Code: 2480 Intended for urinary drainage from the bladder of a patient
Open, Classified
FCMK903340
Aug 26, 2022Mckesson Medical-Surgical Inc. Corporate Office
MEDLINE INDUSTRIES Medline Catheter Insertion Tray Medline Foley Without Catheter Without Balloon Model Number: DYND10160
Open, Classified
FCMNone listed
Aug 6, 2014Teleflex Medical
RUSCH Foley Urinary Catheter Insertion Tray with 10cc syringe, BZK Swabs, Sterile, Rx only, Teleflex Medical Product Code: 76730.
Terminated
FCMK901185
Mar 21, 2012Customed, Inc
Urethral Catheter Tray catalog# 900-278
Terminated
FCMK961442
Mar 21, 2012Customed, Inc
Universal drainage kit, catalog# 900-032
Terminated
FCMK961442
Oct 21, 2011Go Medical Industries Pty., Ltd.
O'Neil Sterile Field Intermittent Urinary Catheter Kit labeled in mart:"***ORIGINAL CLOSED SYSTEM BY DR O'NEIL O'NEIL STERILE FIELD INTERMITTENT URINARY CATHETER KIT WITH IODINE SWABSTICKS (3)*** REF:
Terminated
FCMK002803
Oct 21, 2011Go Medical Industries Pty., Ltd.
O'Neil Sterile Field Intermittent Urinary Catheter Kit labeled in mart:"***ORIGINAL CLOSED SYSTEM BY DR O'NEIL O'NEIL STERILE FIELD INTERMITTENT URINARY CATHETER KIT WITH IODINE SWABSTICKS (3)*** REF:
Terminated
FCMK002803
Oct 21, 2011Go Medical Industries Pty., Ltd.
O'Neil Sterile Field Intermittent Urinary Catheter Kit labeled in mart:"***ORIGINAL CLOSED SYSTEM BY DR O'NEIL O'NEIL STERILE FIELD INTERMITTENT URINARY CATHETER KIT WITH IODINE SWABSTICKS (3)*** REF:
Terminated
FCMK002803
Oct 21, 2011Go Medical Industries Pty., Ltd.
O'Neil Sterile Field Intermittent Urinary Catheter Kit labeled in mart:"***ORIGINAL CLOSED SYSTEM BY DR O'NEIL O'NEIL STERILE FIELD INTERMITTENT URINARY CATHETER KIT WITH IODINE SWABSTICKS (3)*** REF:
Terminated
FCMK002803
Oct 21, 2011Go Medical Industries Pty., Ltd.
O'Neil Sterile Field Intermittent Urinary Catheter Kit labeled in mart:"***ORIGINAL CLOSED SYSTEM BY DR O'NEIL O'NEIL STERILE FIELD INTERMITTENT URINARY CATHETER KIT WITH IODINE SWABSTICKS (3)*** REF:
Terminated
FCMK002803
May 25, 2011Nurse Assist, Inc
Case Label: REF UT8155 Urethal Insertion Tray 14 Fr Red Rubber Catheter with BZK Swabs Qty: 20 For Rx Only Sterile unless package is damaged or opened. STERILE EO Manufactured for: Coloplast A/S 30
Terminated
FCMNone listed
May 25, 2011Nurse Assist, Inc
Case Label: REF UT8150 Urethral Insertion Tray 14 Fr Red Rubber Catheter with PVP Swabs Qty: 20 For Rx Only Sterile unless package is damaged or opened. STERILE EO Manufactured for: Coloplast A/S
Terminated
FCMNone listed
May 25, 2011Nurse Assist, Inc
Case Label: REF UT 8145 Urethral Insertion Tray 14Fr Nelaton PVC Catheter with BZK Swabs Qty: 20 For Rx Only Sterile unless package is damaged or opened. Latex Free STERILE EO Distributed by: Colo
Terminated
FCMNone listed
May 25, 2011Nurse Assist, Inc
Case Label: UT8140 Urethral Insertion Tray 14 Fr Nelaton PVC Catheter with PVP Swabs Qty: 20 For Rx Only Sterile unless package is damaged or opened. Latex Free STERILE EO Distributed by: Coloplas
Terminated
FCMNone listed
May 25, 2011Nurse Assist, Inc
Case Label: REORDER NO. 7504 (STERILE) WELCON BRAND FOLEY CATHETER TRAY w/o Catheter w/30ml. Prefilled Syringe includes BZK Swabsticks nurse assist incorporated 20 ea/Box 800-649-6800 3400 Northern C
Terminated
FCMNone listed
May 25, 2011Nurse Assist, Inc
Case Label: REORDER NO. 7503 (STERILE) WELCON BRAND FOLEY CATHETER TRAY w/o Catheter w/10ml. Prefilled Syringe includes BZK Swabsticks nurse assist incorporated 20 ea/Box 800-649-6800 3400 Northern C
Terminated
FCMNone listed
May 25, 2011Nurse Assist, Inc
Case Label: REORDER NO. 7502 (STERILE) WELCON BRAND URETHRAL CATHETER TRAY w/Red Rubber Catheter includes BZK Swabsticks Caution: Contains Natural Latex nurse assist incorporated 20 ea/Box 800-649-6
Terminated
FCMNone listed
May 25, 2011Nurse Assist, Inc
Case Label: REORDER NO. 7501 (STERILE) WELCON BRAND URETHRAL CATHETER TRAY w/ Plastic Catheter includes BZK Swabsticks nurse assist incorporated 20 ea/Box 800-649-6800 3400 Northern Cross Blvd. Fort
Terminated
FCMNone listed
May 25, 2011Nurse Assist, Inc
Case Label: REORDER NO. 7500 (STERILE) WELCON BRAND URETHRAL CATHETER TRAY w/o Plastic Catheter includes BZK Swabsticks nurse assist incorporated 20 ea/Box 800-649-6800 3400 Northern Cross Blvd. For
Terminated
FCMNone listed
May 25, 2011Nurse Assist, Inc
Case Label: REORDER NO. 7402 (STERILE) WELCON BRAND URETHRAL CATHETER KIT (Female) nurse assist incorporated 25 ea/Box 800-649-6800 3400 Northern Cross Blvd. Fort Worth, TX 76137 www.nurseassist.com
Terminated
FCMNone listed
May 25, 2011Nurse Assist, Inc
REORDER NO. 7305WTU (NON-STERILE) WELCON BRAND FOLEY CATHETER TRAY w/o Catheter w/10ml. Prefilled Syringe this product is intended to be sterilized by the end processor nurse assist incorporated 20
Terminated
FCMNone listed
May 25, 2011Nurse Assist, Inc
Case Label: REORDER NO. 7305 (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
FCMNone listed
May 25, 2011Nurse Assist, Inc
Case Label: REF UT1002 Irrigation Tray with 60 cc Piston Syringe Qty: 20 For Rx Only Sterile unless package is damaged or opened. Latex Free Manufactured for: Coloplast A/S 3050 Denmark STERILE
Terminated
FCMNone listed
May 25, 2011Nurse Assist, Inc
Case Label: REF UT1001 Irrigation Tray with 60 cc Bulb Syringe Qty: 20 For Rx Only Sterile unless package is damaged or opened. Latex Free Manufactured for: Coloplast A/S 3050 Denmark STERILE EO
Terminated
FCMNone listed
May 25, 2011Nurse Assist, Inc
Case Label: REORDER NO. 6122 STERILE WELCON BRAND 60cc PISTON SYRINGE With Sterile Saline 20 ea/Box nurse assist incorporated 800-649-6800 3400 Northern Cross Blvd. Fort Worth, TX 76137 www.nurseassi
Terminated
FCMNone listed
May 25, 2011Nurse Assist, Inc
Case Label: REORDER NO. 6121 STERILE WELCON BRAND 2-Piece 60cc BULB SYRINGE With Sterile Saline 20 ea/Box nurse assist incorporated 800-649-6800 3400 Northern Cross Blvd. Fort Worth, TX 76137 www.nur
Terminated
FCMNone listed
May 25, 2011Nurse Assist, Inc
Case Label: REORDER NO. 6112 STERILE WELCON BRAND 60cc PISTON SYRINGE With Sterile Water 20 ea/Box nurse assist incorporated 800-649-6800 3400 Northern Cross Blvd. Fort Worth, TX 76137 www.nurseassis
Terminated
FCMNone listed
May 25, 2011Nurse Assist, Inc
REORDER NO. 6111 STERILE WELCON BRAND 60cc BULB SYRINGE With Sterile Water 20 ea/Box nurse assist incorporated 800-649-6800 3400 Northern Cross Blvd. Fort Worth, TX 76137 www.nurseassist.com Intended
Terminated
FCMNone listed
May 25, 2011Nurse Assist, Inc
Case Label: REORDER NO. 6104 STERILE WELCON BRAND Economy Irrigation Tray Grommetless Poly-Pro Piston Syringe 20 ea/Box nurse assist incorporated 800-649-6800 3400 Northern Cross Blvd. Fort Worth, TX
Terminated
FCMNone listed
May 25, 2011Nurse Assist, Inc
Case Label: REORDER NO. 6103 STERILE WELCON BRAND Economy Irrigation Tray Standard Green Bulb Syringe 20 ea/Box nurse assist incorporated 800-649-6800 3400 Northern Cross Blvd. Fort Worth, TX 76137 w
Terminated
FCMNone listed
May 25, 2011Nurse Assist, Inc
Case Label: REORDER NO. 6102 STERILE WELCON BRAND Standard Irrigation Tray Thumb Control Ring Piston Syringe 20 ea/Box nurse assist incorporated 800-649-6800 3400 Northern Cross Blvd. Fort Worth, TX
Terminated
FCMNone listed
May 25, 2011Nurse Assist, Inc
Case Label: REORDER NO. 6101 STERILE WELCON BRAND Standard Irrigation Tray Clear-Vu Bulb Syringe 20 ea/Box nurse assist incorporated 800-649-6800 3400 Northern Cross Blvd. Fort Worth, TX 76137 www.nu
Terminated
FCMNone listed
May 25, 2011Nurse Assist, Inc
Case Label: McKesson Medi-Pak Irrigation Tray With Thumb-Control Ring Piston Syringe Sterile Single Use Disposable Latex-Free 20 Trays Per Case Reorder No. 37-104 Marketed By McKesson Corporation McK
Terminated
FCMNone listed
May 25, 2011Nurse Assist, Inc
Case Label: McKESSON Medi-Pak Irrigation Tray With Bulb Syringe Sterile Single Use Disposable Latex-Free 20 Trays Per Case Reorder No. 37-103 Marketed By McKesson Corporation McKesson Medical-Surgica
Terminated
FCMNone listed
Aug 4, 2005Teleflex Medical
Rusch/MMG Urinary Catheterization System, 14 Fr; the single use sterile kit contains a Rusch/MMG Intermittent Catheter, gauze tissue, povidone iodine swabs, two vinyl gloves and underpad; 100 kits per
Terminated
FCMK010420

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