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)
Top companies in FCM
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Sep 6, 2024 | MEDLINE 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 |
FCM | None listed |
| Feb 16, 2024 | Cardinal 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 |
FCM | K903340 |
| Aug 3, 2023 | MEDLINE 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 |
FCM | None listed |
| Dec 2, 2022 | Cardinal 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 |
FCM | K903340 |
| Dec 2, 2022 | Cardinal 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 |
FCM | K903340 |
| Dec 2, 2022 | Cardinal Health Dover Closed Urethral Tray with Vinyl Catheter
Product Code: 3420
Intended for urinary drainage from the bladder of a patient Open, Classified |
FCM | K903340 |
| Dec 2, 2022 | Cardinal 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 |
FCM | K903340 |
| Dec 2, 2022 | Cardinal 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 |
FCM | K903340 |
| Dec 2, 2022 | Cardinal 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 |
FCM | K903340 |
| Aug 26, 2022 | Mckesson Medical-Surgical Inc. Corporate Office MEDLINE INDUSTRIES Medline Catheter Insertion Tray Medline Foley Without Catheter Without Balloon
Model Number: DYND10160 Open, Classified |
FCM | None listed |
| Aug 6, 2014 | Teleflex Medical RUSCH Foley Urinary Catheter Insertion Tray with 10cc syringe, BZK Swabs, Sterile, Rx only, Teleflex Medical Product Code: 76730. Terminated |
FCM | K901185 |
| Mar 21, 2012 | Customed, Inc Urethral Catheter Tray catalog# 900-278 Terminated |
FCM | K961442 |
| Mar 21, 2012 | Customed, Inc Universal drainage kit, catalog# 900-032 Terminated |
FCM | K961442 |
| Oct 21, 2011 | Go 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 |
FCM | K002803 |
| Oct 21, 2011 | Go 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 |
FCM | K002803 |
| Oct 21, 2011 | Go 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 |
FCM | K002803 |
| Oct 21, 2011 | Go 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 |
FCM | K002803 |
| Oct 21, 2011 | Go 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 |
FCM | K002803 |
| May 25, 2011 | Nurse 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 |
FCM | None listed |
| May 25, 2011 | Nurse 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 |
FCM | None listed |
| May 25, 2011 | Nurse 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 |
FCM | None listed |
| May 25, 2011 | Nurse 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 |
FCM | None listed |
| May 25, 2011 | Nurse 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 |
FCM | None listed |
| May 25, 2011 | Nurse 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 |
FCM | None listed |
| May 25, 2011 | Nurse 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 |
FCM | None listed |
| May 25, 2011 | Nurse 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 |
FCM | None listed |
| May 25, 2011 | Nurse 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 |
FCM | None listed |
| May 25, 2011 | Nurse 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 |
FCM | None listed |
| May 25, 2011 | Nurse 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 |
FCM | None listed |
| May 25, 2011 | Nurse 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 |
FCM | None listed |
| May 25, 2011 | Nurse 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 |
FCM | None listed |
| May 25, 2011 | Nurse 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 |
FCM | None listed |
| May 25, 2011 | Nurse 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 |
FCM | None listed |
| May 25, 2011 | Nurse 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 |
FCM | None listed |
| May 25, 2011 | Nurse 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 |
FCM | None listed |
| May 25, 2011 | Nurse 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 |
FCM | None listed |
| May 25, 2011 | Nurse 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 |
FCM | None listed |
| May 25, 2011 | Nurse 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 |
FCM | None listed |
| May 25, 2011 | Nurse 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 |
FCM | None listed |
| May 25, 2011 | Nurse 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 |
FCM | None listed |
| May 25, 2011 | Nurse 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 |
FCM | None listed |
| May 25, 2011 | Nurse 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 |
FCM | None listed |
| Aug 4, 2005 | Teleflex 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 |
FCM | K010420 |
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