| 25 Jun 2026 | Products that contain the Pericare Wipes: Bardex Lubricath Foley Catheter Tray REF: 899914 899916 899918 UDI codes: 00801741024801¿ 10801741024808 00801741024818¿ 10801741024815 00801741024825¿ 10801741024822 SureStep" Foley Tray System with Bardex¿ Lubricath Temp Sensing Foley Catheter REF: A119416M UDI code:… | Device | Class II | 6 | Ongoing |
| 23 Apr 2026 | Silastic Foley Catheters Silastic Brand Foley Catheter 30cc REF: 33416 33418 33420 33422 33424 Silastic Brand Foley Catheter 5cc REF: 33614 33616 33618 33620 33622 33624 | Device | Class II | 1 | Ongoing |
| 6 Nov 2025 | Bard InLay Optima Size: 6 Fr. x 14 cm, Ureteral Stent Kit REF 787614 | Device | Class II | 4 | Ongoing |
| 17 Jul 2025 | SureStep Foley Tray System Bardex I.C. Complete Care Infection Control Foley Catheter Tray, REF: A303316A | Device | Class II | 3 | Ongoing |
| 18 Jun 2025 | Bardex Lubri-Sil I.C. 400-series Temperature Sensing Silver/Hydrogel Coated All-Silicone Foley Catheter 5cc Balloon, REF: 119314; SureStep Foley Tray System Lubri-Sil I.C. Complete Care, REF: A319514A; Bard Silver Lubri-Sil Foley Tray Temperature Sensing with Bard Hydrogel and Bacti-Guard Silver Alloy Coating, 14Fr,… | Device | Class II | 1 | Ongoing |
| 3 Jun 2025 | BD Heyman Follower Straight Tip for following sizes: 10Fr - REF:21110, 12Fr - REF:21112, 14Fr - REF: 21114, 20Fr - REF: 21120 | Device | Class II | 3 | Ongoing |
| 17 Apr 2025 | Bard Minnesota Four Lumen Esophagogastric Tamponade Tube, REF:0092220 18 Fr. (6mm, 7/32"), 41" Length (104cm) with 8" (20.3cm) Balloon X-Ray Opaque Rubber | Device | Class I | 5 | Ongoing |
| 9 May 2024 | Bard Medical SureStep Foley Tray System, 16 Fr., Catalog #A319416AM; and Bard Medical Bardex IC Complete Care Infection Control Temperature-Sensing Foley Catheter Tray with Bard Hydrogel and Bacti-Guard Silver Alloy Coating, 350 ml Urine Meter, 16 Fr, Catalog #319416AM. Intended for use in the drainage and/or… | Device | Class II | 1 | Ongoing |
| 20 Dec 2023 | Bard Nasogastric Sump Tube with ENFit, 10Fr., 36in Long, REF EN0042100 | Device | Class II | 17 | Ongoing |
| 15 Nov 2023 | Sensica Urine Output System, Catalog Number SCCS1002 | Device | Class II | 1 | Ongoing |
| 20 Apr 2023 | Magic3 Go Intermittent Urinary Catheters, Female Catalog Numbers: a) REF 51808, b) REF 51810, c) REF 51812, d) REF 51814, e) REF 51816, f) REF 51818 | Device | Class II | 4 | Ongoing |
| 19 May 2022 | Sensica Urine Output System | Device | Class II | 1 | Ongoing |
| 27 Jan 2022 | BARD SURESTEP INTERMITTENT CATHETER TRAY, 14Fr, REF INTS14C | Device | Class II | 2 | Terminated |
| 5 Aug 2021 | Catalog A119216M, SureStep" Foley Tray, Lubri-Sil", Urine Meter, Temperature Sensing Dual, StatLock" Stabilization Device | Device | Class II | 21 | Ongoing |
| 11 Jan 2021 | Bard Clean-Cath Intermittent Catheter, 12 French female length (catheter, urological) - Product Usage: for urological use only. | Device | Class II | 1 | Terminated |
| 15 Apr 2020 | SureStep Foley Tray System - Product Usage: Intended for use in the drainage and/or collection and/or measurement of urine. Generally, drainage is accomplished by inserting the catheter through the urethra and into the bladder. However, drainage is sometimes accomplished by suprapubic or other placement of the… | Device | Class II | 1 | Terminated |
| 13 Jan 2020 | The Bard Intra-abdominal Pressure Monitoring Device is composed of a tubing set used for infusing fluid into the urinary bladder through the Foley catheter sampling port. It utilizes a clamping device to occlude the urinary drainage tubing to form a fluid column through which pressure is measured. | Device | Class II | 1 | Terminated |
| 27 Feb 2018 | Bard(R) Premature Infant Feeding Tube, ENFit(TM), REF EN0036400 Product Usage: BARD(R) Nasogastric Sump Tubes with ENFit(TM) connector are intended to be used for: Decompression of stomach by suction or aspiration of gastric contents Short-term administration of term tube feeding, lavage fluid and medications Feeding… | Device | Class II | 4 | Terminated |
| 13 Dec 2017 | Bardex Lubricath 3-Way 75cc Continuous Irrigation Foley Catheter (Creevy), 22Fr. Rx (01267522) | Device | Class II | 1 | Terminated |
| 10 Nov 2017 | CritiCore Automated Urine Output and Temperature Monitor | Device | Class II | 1 | Ongoing |
| 10 Nov 2017 | BARD(R) CRITICORE(R) MONITOR, Model: 000002N Series The CritiCore(R) Automated Urine Output and Temperature Monitor is indicated to monitor urine output and core bladder temperature. | Device | Class II | 1 | Terminated |
| 16 Oct 2017 | Medivance ArcticGel Small Pad Kit - a box containing a single foil pouch, which contains a set of four (4) pads. A set of pads comprise a left and a right torso pad, and a left and a right thigh pad. Is a Thermal regulating system, indicated for monitoring and controlling patient temperature in adult and pediatric… | Device | Class II | 1 | Terminated |
| 29 Sep 2017 | BARD UROS AUTOMATED URINE OUPTUT AND TEMPERATURE MONITOR, MODEL BK10001M The Uros(TM) Automated Urine Output and Temperature Monitor is indicated to monitor urine output and core bladder temperature. | Device | Class II | 1 | Terminated |
| 14 Sep 2017 | HydroSil Gripper Intermittent Catheters- 10" lengths - 30 catheters per box, each catheter is packaged in an individual pouch. MGC3 Product Usage Intermittent catheters are intended for urinary bladder drainage in patients requiring catheterization for management of incontinence, voiding dysfunction, and surgical… | Device | Class II | 3 | Terminated |
| 28 Jul 2017 | Bard Magic 3 Antibacterial Hydrophilic Intermittent Catheter Female, 14 FR (30/box), Rx Only intended for urinary bladder drainage in patients requiring catheterization for management of incontinence, voiding dysfunction, and surgical procedures. | Device | Class II | 1 | Terminated |
| 2 Jun 2017 | BARD DISPOZ-A-BAG Leg Bag with Flip-Flo Valve with Drain Extension, Extension Tube and Latex Straps, 19 oz. Packaged as single unit in thermoformed trays. There are 50 units per case. Product Usage: Vinyl leg bag to be used with male external catheters, Foley catheters, or moth other types of urinary catheters, which… | Device | Class II | 1 | Terminated |
| 2 Jun 2017 | Arctic Sun ArcticGel Pads - Medium, Product Code 317-07 | Device | Class III | 1 | Ongoing |
| 31 Mar 2017 | Arctic Sun 5000 Temperature Management System, 100-120 V North America and 100-120 V US | Device | Class II | 1 | Ongoing |
| 9 Mar 2017 | SURESTEP Tray, Bardex I.C. Complete Care Drainage Bag, 2000 ml Drainage Bag, 16 Fr., Sterile. | Device | Class II | 1 | Completed |
| 9 Dec 2016 | I-125 CE Marked QuickLink Cartridges; Sterile; Bard Brachysource Radioactive Seeds in QuickLink Cartridges Indicated for permanent interstitial treatment of selected localized tumors such as: head and neck, lung, pancreas, and early stage prostate. Implants are indicated to treat residual tumors following completion… | Device | Class II | 1 | Terminated |
| 13 Oct 2016 | Bard Fluoro-4 Silicone Ureteral Stent, Bard¿ Fluoro-4", Silicone Ureteral Coil Stent; Bard¿ Silicone Uretera l Coil Stent with Figure Four, End, Manufacturer: C.R. Bard, Inc., Covington, GA 30014. | Device | Class II | 4 | Terminated |
| 12 Oct 2016 | C-Max" Cutting Loop Electrodes, Storz One-Stem, 24 Fr, .014in., .35 mm, Sterile, Rx only, Manufactured by: C.R. Bard, Inc., Covington, GA 30014. | Device | Class II | 1 | Terminated |
| 12 Oct 2016 | X-Force Nephrostomy Balloon Dilation Catheter Kit with Inflation Device, PTFE Sheath, 8 mm x 15 cm, Product Code 996081 The product is a dual lumen catheter with a 24 (8mm) or 30Fr (10mm) balloon mounted on the distal tip. It has a radiopaque tip and radiopaque marker beneath the balloon. It is recommended for use in… | Device | Class II | 1 | Terminated |
| 5 Oct 2016 | Magic3 Antibacterial Hydrophilic Intermittent Catheter, Male 14 Fr. (30/Box), Sterile Product Usage: The catheter is an all silicone, single lumen, drainage tube with drainage eyes at the proximal end and a tapered funnel at the distal end. The outer surface of the catheter has an antibacterial and hydrophilic… | Device | Class II | 1 | Terminated |
| 3 Aug 2016 | BARD¿ Irrigation, Syringe 70cc With Resectoscope Tip, Catheter Tip, Luer Adapter And Cap, Rx Only, Sterile, The BARD¿ Syringe is available in a single use plastic design which features a 60cc or 70cc capacity graduated barrel. It has a thumb ring plunger for one-handed use. A catheter adapter tip and Luer adapter tip… | Device | Class II | 4 | Terminated |
| 11 Jul 2016 | Option-vf Urinary Catheter. Female use only. Latex Free. Sterile, Rx only. | Device | Class II | 2 | Terminated |
| 11 Jul 2016 | SURESTEP Tray, BARDEX I.C. COMPLETE CARE, Urine Meter, Temperature STATLOCK Stabilization Device | Device | Class II | 1 | Terminated |
| 30 Jun 2016 | Medivance ArcticGel Neonatal Pad The pad is designed to fit into an incubator and provide whole body cooling for patients. | Device | Class III | 1 | Terminated |
| 29 Jun 2016 | SureStep Tray, with Add-a-Foley, COMPLETE CARE, Drainage Bag, and STATLOCK Stabilization The product is a urine collection system that includes a STATLOCK Foley Stabilization Device | Device | Class III | 1 | Terminated |
| 4 Mar 2016 | BARD ArcticGel Pads Product Usage: The Arctic Sun Temperature Management System is intended for monitoring and controlling patient temperature. ArcticGel Pads are only for use with an Arctic Sun Temperature Management System Control Module. | Device | Class II | 1 | Terminated |
| 4 Jan 2016 | REF 0038460 Toomey Syringe 70cc Syringe with Catheter Tip and Luer Tip Adapters, Single Use, Rx Only, Latex Free, 50 units. Product Usage: Product is intended for Resectoscope irrigation, catheter irrigation and Foley catheter inflation. | Device | Class III | 1 | Terminated |
| 18 Dec 2015 | BARDEX I.C. Anti-Infective 2-Way 3cc Foley Catheter, Rx only. Intended for urinary bladder drainage in female patients requiring catheterization for management of incontinence, voiding dysfunction and surgical procedure. | Device | Class II | 3 | Terminated |
| 10 Nov 2015 | Arctic Sun 5000 and Arctic Sun 2000; Intended for monitoring and controlling patient temperatures. | Device | Class II | 1 | Terminated |
| 9 Nov 2015 | Arctic Sun Temperature Management System, 5000, 100-120V and 220-240V The product is a thermal regulating system indicated for monitoring and controlling patient temperature | Device | Class II | 1 | Terminated |
| 2 Oct 2015 | Antibacterial Hydro Personal Catheter, Male 12 Fr, Product Code 63512, sold in boxes of 30 units | Device | Class III | 1 | Terminated |
| 24 Aug 2015 | 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 Intermittent Urinary Catheter | Device | Class II | 1 | Terminated |
| 7 Jul 2015 | Magic3 Hydrophilic-coated Female Intermittent Urinary Catheters (6"), 10 Fr, (30/box), Product Code 51610. Intermittent catheter. | Device | Class II | 5 | Terminated |
| 30 Jan 2015 | Bard 100% Latex-Free Urinary Drainage Bag with Anti-Reflux Chamber and Bard EX-Lok Sampling; Product Code 154006: Lot # NGYJ0603 and NGYJ1671 | Device | Class II | 1 | Terminated |
| 7 Oct 2014 | Bard Dimension Stone Basket Product Usage: The Bard Dimension Stone basket is a teardrop-shaped basket with the ability to capture stones by, opening and closing the basket and articulating or moving the basket from side to side. The device consists of 3 main parts; handle, shaft and basket. It is intended to use in… | Device | Class II | 1 | Terminated |