Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

1018233

FEI Number

1018233

Entity Name

C.R. BARD, INC.

City/State/Country

COVINGTON, GA, US

Establishment Address

8195 INDUSTRIAL BLVD., COVINGTON, GA 30014, US

Establishment Type(s)

Sterilize Medical Device for Another Party (Contract Sterilizer)

Owner / Operator

C. R. Bard, Inc. (Owner Number: 2212754)

Owner / Operator Contact Address

1 Becton Drive, Franklin Lakes, NJ 07417, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Ultraverse 014 and 018 PTA Balloon Dilatation Catheters Bardex Lubri-Sil 3-Way Foley Cathet Bardex Lubri-Sil I.C. Foley Cathete BD Intelliport Sensor CO-SET+ Loc-Strap Bard Male External Catheter (OTC) Bard Infection Control Urinary Needleless Sample Port Control Fit Urine Collection Container - bag/urinary drainage unit Bard Deluxe Dispoz-A-Bag Drainage Bag (Leg Bag) Urinary Drainage Unit(urinary leg Urotrack Plus (Model 220) Bard Leg Bag Holder w/ accessories) Bed Bag SureStep Foley Tray System Add-A-Foley Catheter (for Canada) Bard Foley Catheterization Tray Uro-Prep Tray (for Canada) SureStep Foley Tray System Complete Care Add-A-Foley Catheter (for Canada) Bard Standard Latex Free Foley Tray without Catheter (for Canada) Bard Male External Latex Disposable Catheter Bardia Foley Catheter Insertion w/o Catheter with Lubricant in SureStep Intermittent Catheter Tray Bard® Universal Catheterization Tray Bardia Urethral Catheter Tray 5cc Balloon w/o Catheter w/o Catheter Foley Catheter Insertion Tray for 30cc Balloon w/o Catheter Bard Foley Catheterization Tray IMPRA Carboflo ePTFE Vascular Grafts True Flow Valvulplasty Perfusion Catheter PelviLace TO BioUrethral Support Sy Per-Q-Cath Catheter Introducer Bardex Lubri-Sil I.C. Foley Cath Lubri-Sil I.C. Foley Catheter (offered in strips and trays) Tracheal Suction Latex rubber Suction System Trach-Eze Closed Ventilation Bard Plastic Cath N Sleeve Bard Cath'N Sleeve with Solution Container Davol DeLee Tracheal Davol Tracheal Suction Catheter Bard Suction Catheter, DeLee Tracheal Bard Cath'N Sleeve Suction Kit Bard Catheter and Glove Suction Kit Davol Suction Catheter Bard Suction Catheter Bard Plastic Suction Catheter Davol Bronchial Aspirating Catheter Bard Tracheal Suction Tray Align Urethral Support System Economy 400 CWS with PVC Drain 100cc Silicone Evacuator ReliaVac 100 Closed Wound Suction 3-spring Y-connector BD Curve Ascites Shunt 42-4016, Introducer Kit 42-4012, Introducer Kit Bard Malleable Tip Catheter Stylet "J" Guidewires Bard Nitinol Guidewires Hyrdo-Glide Guidewire Bard Van Buren Curve Catheter Style NiCore Nitinol Guidewires Bard Mission Disposable Core Biopsy Instrument Bard Mission Disposable Core Biopsy Instrument Kit Bardex 9cm Latex Right Angle Drain Bard Heyman Nephrostomy Short Tip Bard Suprapubic Needle Adapter Bardex Heyman Nephrostomy Short Tip Councill Model Hollow Stylet Suprapubic Trocar and Cannula (Campbell Model) Concil Model Hollow Stylet Bard Specimen Container Hysterectomy "T" Drain Bard Suction Connector Catheter Repair Kit with Replacement Connector UltraScore Focused Force PTA Balloon Bard Cunnigham Incontinence Clamp Bard Penile Clamp Safe-T-Plus Safe-T-Centesis Dilation Catheter X-Force TM Nephrostomy Balloon BARD CARDIOTHORACIC ADAPTOR Max-Blade Coagulating Resector Bard Woven Phillips Follower PHILLIPS AND HEYMAN Bard Heyman Follower Straight Tip Huber Plus EndoBeam Holmium Laser Fibers Catheter Plug Bard Fecal Containment Device with Adhesive and Accessories Provena Midline Catheter SureStep Foley Tray System (for Canada) Bardex Lubricath Foley Catheter (for Canada) Preconnected Bardex Lubricath Catheter (for Canada) Bard Urine Meter Bladder Care Tray with Bardex Lubricath Foley Catheter (for Canada) SureStep Foley Tray System Bardex Lubricath Coude Foley Catheter (for Canada) Bard Urine Meter Foley Tray with Bardex Lubricath Foley Catheter (for Canada) Bard Foley Tray with Bard HydrophilicCoated Foley Catheter (for Canada) SureStep Foley Tray System Bard Lubricath Foley (for Canada) VAMP Venous/Arterial Blood Management Protection System PowerGlide Pro Midline Catheter PowerGlide Pro Midline Catheter with Cue Needle Tracking System StruXure Guidewire Alphacurve HemoSplit XK Rosenblatt Port Align Introducers Fast Track Tunneler Set PelviSoft Introducers InSnare Introducers Bard Latex Urethral Catheter (Tieman Model) Coude Tip Bardia Red Rubber Intermittent Catheters Syringe Assist Irrigation System Bard Syringe Assist Irrigation Syst PowerPort ClearVUE Slim Implantable Port MRI Port Anti-Reflux Filter Nasogastric Sump Tube with PreVent Pressure Monitoring Set Bardex I.C. Pediatric Foley Cath Whelan Moss T-Tubes (biliary catheter) Statlock Foley Catheter Stabilization Device VAMP Plus Venous/Arterial Blood Management Protection System Swan-Ganz Catheter MRI Hard Base Port UltraClip II MR Tissue Marker Pediatric & Infant Catheter Kit PowerPort with Groshong Catheter Fogarty Thru-Lumen Embolectomy Catheter MRI PowerPort DENVER PLEURAL EFFUSION SHUNT WITH EXTERNAL PUMP CHAMBER DENVER PLEURAL EFFUSION SHUNT Bard Mesh BARD Bard Mesh Pre-Shaped UltraCor Twirl Breast Tissue Marker VAMP Venous/Arterial Blood Management Protection System Pressure Monitoring Set Acumen IQ Fluid Meter Hohn Broviac Stabilization Device Statlock Endotracheal Tube Bone marrow collection/transfusion kit Reliacath Nelation Catheter Safe-T-Centesis Titanium Port Bardex Lubri-Sil Foley Catheter Lubri-Sil Foley Catheter Nasogastric Sump Tube Dual Lumen, w Radiopaque Stripe Marks Groshong NXT Groshong NXT ClearVue Bard Extension Set Silastic Brand Foley Catheter Bard® Silastic® Foley Catheter DuaLok Breast Lesion Localization Wire Ghiatas Beaded Breast Localization Wire Eagle Inflation Device Bard Nylon Catheter Plug Bard Catheter Plug and Cap Foley Catheters Drains, Balloon Inflation Funnel on Bard "C" Clamp for Occluding Tubes, Hydrogel-Coated Urethral Catheter Bardex I.C. 4-Way Foley Catheter Pristine Long Term Hemodialysis Catheter Poly Per-Q-Cath Silicone Ureteral Coil Stent with Figure Four End Fluoro-4 Silicone Ureteral Coil Stent Fluoro-4 Silicone Ureteral Stent Urinary Diversion Stent Bard Silicone Ureteral Stenting BrachyStar Brachytherapy Needles brachytherapy seed implant needles BrachyStar Needles QuickLink Loader QuickLink Relay System SourceLink Loader Bard Davol ReliVac Stainless Steel Trocar Fogarty Graft Thrombectomy Catheter Fogarty Corkscrew Catheter Safe-T-Centesis Thora-Para Safe-T PLUS Option-VF Urinary Catheter with Adaptor Bard Magnum Reusable Core Biopsy Instrument Ultraverse 035 PTA Balloon Dilatation Catheter Fogarty Arterial Embolectomy Catheter PleurX Peritoneal Catheter System Tridyne PowerPICC Swan-Ganz Pacing-TD Catheter BARD URODYNAMIC CATHETER Groshong PICC Latex Foley Catheter Bardex I.C. Foley Catheter (offered in strips and trays) TruGuide Coaxial Biopsy Needles Bard TruGuide Disposable Coaxial Biopsy Needles PTFE Coated Foley Catheter w/ urine collection bag LubriSil Foley Catheter w/ collection bag PTFE Coated Foley Catheter w/ Leg Bag Hydrogel Coated Foley Catheter with Leg Bag Silicone Catheter Tray with Accessories including Leg Bag Hydrogel Coated Foley Catheter with Urine Collection Bag LubriSil Foley Catheter with Leg Bag Bard Foley Tray with Bardex All Silicone Foley Catheter (for Canada) PTFE Coated Foley Catheter w/ Urine Meter SureStep Foley Tray System Bardex All- Silicone Foley Catheter Tray (for Canada) Silicone Catheter Tray with accessories LubriSil Foley Catheter with urine collection bag Silicone Foley Catheter w/ urine collection bag PTFE Coated Foley Catheter w/ Bed Bag Hydrogel Coated Foley Catheter w/ urine collection container LubriSil Foley Catheter w/ urine collection container PTFE Coated Foley Catheter w/ urine collection container SureStep Foley Tray System Lubri-Sil Complete Care (for Canada) Bard Urine Meter Foley Tray With Bardex All-Silicone Foley Catheter (for Canada) SureStep Foley Tray System Bard Lubri-Sil Foley Catheter Tray (for Canada) SureStep Foley Tray System Bard All Silicone Foley Catheter Tray (for Canada) T-Handle Jamshidi Bone Marrow Biopsy and Aspiration Tray Rubber Utility Catheter Bard Red Rubber Utility Catheter SureStep Intermittent Catheter Tray Viking Diagnostic Electrode Tango Electrode Catheters Viking Soft Tip Electrode Catheters Presto Inflation Device X-Force Ureteral Dilation Balloon C Bard U-Balloon Dilation Catheter UROFORCE Ultraverse 014 and 018 PTA Balloon Dilatation Catheters Balloon Bipolar Temporary Pacing Electrode Catheter Illinois Bone Marrow Aspiration Needle Illinois Bone Marrow Aspiration Tray T-Handle Illinois Bone Marrow Aspiration Tray Safe-T PLUS Tray T-Handle Illinois Bone Marrow Aspiration Needle PowerPort ClearVUE isp Implantable Ports PowerPort ClearVUE Slim Implantable Ports Hydro-Surg Extension tube Ajust Adjustable Single Incision Plastic Catheter Bard Silicone Elastomer-Coated Latex Foley Catheter Flexxicon Niagara Non-Sterile Vinyl Inlay Ureteral Stent with Hydroglid Inlay VersaFit Multilength Ureteral Inlay Uteral Stent Inlay VersaFit Ureteral Stent UltraClip II Tissue Marker Wing and UltraClip II Tissue Marker Coil Non-sterile Urine Collection Bag Bard Jejunal Tube Gastrointestinal Tube X-Force Nephrostomy Balloon Dilation Catheter Recon Support Catheter Vacuum Tubing Patient Tubing PureWick FEC Collection Canister PureWick Urine Collection Accessories Kit PureWick Urine Collection System PureWick MEC PureWick Male External Catheter PureWick Female External Catheter Pressure Monitoring Set Nasopharyngeal Airway Solution Container Acumen IQ Sensor FloTrac Sensor VolumeView Sensor Sherlock GlidePath 10F Long Term Dialysis Catheter Sentrinex 3D Port Dressing Statlock Stabilization Device Accessory - Foam Strips Sensor Holder Wound Closure Tape Strips AllPoints Dressing Change Kit EnCor Breast Biopsy System Accessories Jamshidi Bone Marrow Biopsy and Aspiration Tray T-Handle Jamshidi Bone Marrow Biopsy/Aspiration Needle Instrument, biopsy Jamshidi Bone Marrow Biopsy/Aspiration Needle Jamshidi Evolve Bone Marrow Biopsy and Aspiration Trays Safe-T PLUS Trays Jamshidi Evolve Bone Marrow Biopsy/Aspiration Needle T-Handle Jamshidi Bone Marrow Biopsy and Aspiration Trays Magic3 Go Intermittent Urinary Catheter Arctic Sun Temperature Management System BARDEX LUBRI-SIL LUBRICATH Conquest 40 PTA Dilatation Catheter Atlas Gold PTA Dilatation Catheter Swan-Ganz Catheter FloTrac Jr. Sensor UltraClip II US Tissue Marker Marker (Ribbon) UltraClip Dual Trigger Tissue I.C. Foley Catheter with Urine Collection Container I.C. Foley Catheter AquaFil Foley Catheter with Syringe Foley Catheter with AquaFil Magic3 Touchless Hydrophilic Intermittent Catheter System (for Canada) SureStep Foley Tray System Bardex IC Complete Care (for Canada) Lubri-Sil I.C. Complete Care Urine Meter Foley Tray (for Canada) SureStep Foley Tray System Bardex I.C. Complete Care Foley Catheter (for Canada) SureStep Foley Tray System Lubri-Sil IC Complete Care (for Canada) HemoSplit Alphacurve Bardex All-Silicone Pediatric Cath Bard Silver-Coated Endotracheal Tub True Dilatation Balloon Valvuloplasty Catheter Davol/Simon Dermatone Atlas PTA Balloon Dilatation Catheter Bard Dual Connector to 3.5 mm Plug 12' Monitor Cable Sensica UO System Bard CritiCore Venaflo II Bypass Graft Forceps SureStep Foley Tray System Bard All Silicone Foley Catheter Tray (for Canada) SureStep Foley Tray System Bardex All Silicone Foley Catheter Tray (for Canada) Bard Foley Tray with Bardex All Silicone Foley Catheter (for Canada) Chiba Fine Needle Aspiration Device Avaulta Support System Avaulta Solo Support System Avaulta Plus Support System Magnum Core Biopsy Needles Bard Snare Retrieval Kit Coude Tip Temperature-Sensing Cath CritiCore (Coude) Foley Tray ALIGN AND ALIGN TO URETHRAL SUPPORT SYSTEMS Magic3 UroForce Balloon Dilation Catheter UROFORCE Fogarty Fortis Arterial Embolectomy Catheter Dorado PTA Balloon Catheter Bardex Pezzers Bardex Nephrostomy Bardex Angel Drain Bardex Malecot SorbaFix PermaFix HydroSil Magic3 Clear Advantage ULtraflex Natural Aurora Transfix Wideband PopOn Spirit BD Trek Bone Marrow Biopsy System BD Trek Power Driver BD Trek Bone Lesion Biopsy System BD Trek Sterile Sleeve X-Port Inline X-Port duo Port Evacuator Ellik Evacuator Bard Ellik Bladder Evacuator Avaulta Plus Biosynthetic Support Avualta Solo Synthetic Support Groshong NXT V-Max Roller Bar Electrodes Proxis Ureteral Access Sheath NBIH Temporary Pacing Electrode Catheter Balloon Bipolar Temporary Pacing Electrode Catheter, Right Heart Curve Balloon Bipolar Temporary Pacing Electrode Catheter Semi-Floating Temporary Pacing Electrode Catheter GOETZ Temporary Pacing Electrode Catheter Ureteral Catheter Plastic Adapter SureLink Extension Cables Poly Per-Q-Cath PICC & Midline Vertus Foley Catheter SureStep Recovery Cone Removal System PTFE Felt Bard PTFE Felt Pledget Low Porosity PTFE Felt PTFE Felt (Thick) Bard PTFE Braided Tape Bard PTFE Thick Felt Pledget Campbell Surprapubic Trocar and Cannula Bard Intra-Abdominal Pressure Monitoring Device BARD INTRA-ABDOMINAL PR Bardex Lubri-Sil All-Silicone Lubricious Coated Foley Catheter 6F Bardex Lubri-Sil Catheter (strips and trays) UltraCor Twirl Breast Tissue Marker SlimPort MRI Ultra Low Profile Port MRI Low Profile Port Soft Tissue Biopsy Drug Free Tray Jamshidi Menghini Soft Tissue Biopsy Needle/Syringe Economy Illinois Sternal/lliac Bone Marrow Aspiration Tray Safety Soft Tissue Biopsy Tray Economy Soft Tissue Biopsy Tray Illinois Bone Marrow Aspiration/Intraosseous Infusion Needle Soft Tissue Biopsy Tray Jamshidi Bone Marrow Biopsy/Aspiration Needle Jamshidi Menghini Soft Tissue Biopsy Tray PelviSoft Acellular Collagen Matrix PELVISOFT Magic3 Go Intermittent Urinary Catheter HydroSil Go Intermittent Urinary Catheter GlidePath 13F Long Term Hemodialysis Catheter Niagara SlimCath Bardex All-Silicone Temperature- Sensing Foley Catheter Lubri-Sil I.C. Temperature-Sensing Foley Catheter (offered in strips and trays) Vaccess CT Low-Profile Power-Injectable Implantable Port Vaccess CT Power-Injectable Implantable Port PowerPort duo M.R.I. Implantable Port Kugel Bard Urethral Catheterization Tray Navarre Universal Drainage Catheter Navarre Opti-Drain Drainage Catheter Groshong Stabilization System SurePoint Tracker Stepping and All-Silicone Foley Catheter Lubri-Sil Foley Catheter (offered in strips and trays) Lubri-Sil I.C. Foley Catheter (offered in strips and trays) Bardex Silicone Foley Catheter (offered in strips and trays) and Kit Model 2012 (Urotrack) Temperature Sensing Foley Catheter Urinary Drainage Container with Preattached Foley Catheter and Kit ArcticGel Pads Denali Vena Cava Filter System Femoral and Jugular/Subclavian Delivery Kit Groshong Marquee Disposable Core Biopsy Instrument Marquee Disposable Core Biopsy Instrument Kit Edwards Oximetry Central Venous Catheter BD Oximetry Central Venous Catheter PleurX Touchless II Pre-Lubricated Urethral Kit FloTrac Sensor VolumeView sensor Acumen IQ sensor UltraClip II Tissue Marker Titanium PowerPort isp Site-Rite Needle Guide Kits and Pro Composix Bardex Silicone Foley Catheter Bardex Silicone Foley Catheter (offered in strips and trays) Positioning System Stylet Sherlock 3CG Tip Positioning System Sensor & Sherlock 3CG Tip Bard DigniShield Stool Management System ENFit Bard DigniShield Stool Management System Bard® DigniShield® Stool Management System Collection Bags Bile Bag Crosser iQ CTO Recanalization System Ultraverse RX PTA Balloon Dilatation Catheter ePTFE Cardiovascular Patch PowerLine PowerHohn Dynamic Tip Steerable Catheter Fogarty Spring Clips Clamp Inserts Handleless Clamps Advance Introducer and SecureLoc Safety Introducer SecureLoc Titanium Low Profile Port BardPort Titanium Ports X-Port Low Profile Port UDM-10 Urinary Drainage Monitoring Highlander 014 PTA Balloon Dilatation Catheter PelviLace BioUrethral Dilators Dualator Alyte Y-Mesh Graft Hickman Trifusion Distaflo Bypass Graft PeritX 2L Drainage Starter Pack PeritX 2L Drainage Kit PeritX 2L Drainage Starter Tote PeritX Peritoneal Catheter System PowerPICC SV Catheter Edwards Oximetry Central Venous Catheter PediaSat Oximetry Catheter BD Oximetry Central Venous Catheter Latex Foley Catheter with 30cc Preformed Balloon Bardia Foley Catheter Bard Lubricath Foley Catheter Intravascular Catheter Securement Device IMPRA Carboflo ePTFE Vascular Grafts PowerGroshong PerFix SurePoint Stepping and Stabilization System Pezzer-Malecot Stylet Fogarty Occlusion Catheter GlidePath 7.5F Long-Term Hemodialysis Catheter

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
KNW	Instrument, Biopsy	Gastroenterology, Urology	Class 2	876.1075	2021-07-19
QSY	Hemostatic Wound Dressing Without Thrombin Or Other Biologics	Unknown	Class U	N/A	2013-05-10
LJS	Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days	General Hospital	Class 2	880.5970	2015-11-10
LIT	Catheter, Angioplasty, Peripheral, Transluminal	Cardiovascular	Class 2	870.1250	2019-10-21
MJC	Catheter, Urological (Antimicrobial) And Accessories	Gastroenterology, Urology	Class 2	876.5130	2008-01-07
EZL	Catheter, Retention Type, Balloon	Gastroenterology, Urology	Class 2	876.5130	2008-01-07
FPA	Set, Administration, Intravascular	General Hospital	Class 2	880.5440	2025-08-26
PHC	Infusion Safety Management Software	General Hospital	Class 2	880.5725	2025-08-26
KRB	Probe, Thermodilution	Cardiovascular	Class 2	870.1915	2026-03-26
KNX	Collector, Urine, (And Accessories) For Indwelling Catheter	Gastroenterology, Urology	Class 2	876.5250	2007-02-27
DSY	Prosthesis, Vascular Graft, Of 6mm And Greater Diameter	Cardiovascular	Class 2	870.3450	2007-12-05
OZT	Balloon Aortic Valvuloplasty	Cardiovascular	Class 2	870.1255	2017-12-18
PAG	Mesh, Surgical, Non-Synthetic, Urogynecologic, For Stress Urinary Incontinence, Retropubic Or Transobturator	General, Plastic Surgery	Class 2	878.3300	2007-12-10
DYB	Introducer, Catheter	Cardiovascular	Class 2	870.1340	2007-10-22
MJC	Catheter, Urological (Antimicrobial) And Accessories	Gastroenterology, Urology	Class 2	876.5130	2007-12-07
DYB	Introducer, Catheter	Cardiovascular	Class 2	870.1340	2007-10-22
BSY	Catheters, Suction, Tracheobronchial	Anesthesiology	Class 1	868.6810	2007-02-27
OTN	Mesh, Surgical, Synthetic, Urogynecologic, For Stress Urinary Incontinence, Retropubic Or Transobturator	General, Plastic Surgery	Class 2	878.3300	2007-12-10
GCY	Apparatus, Suction, Single Patient Use, Portable, Nonpowered	General, Plastic Surgery	Class 1	878.4680	2007-02-27
KPM	Shunt, Peritoneal	Gastroenterology, Urology	Class 2	876.5955	2025-09-12
DYB	Introducer, Catheter	Cardiovascular	Class 2	870.1340	2025-09-12
EZB	Stylet For Catheter, Gastro-Urology	Gastroenterology, Urology	Class 1	876.5130	2007-03-14
PTI	Non-Coring (Huber) Needle	General Hospital	Class 2	880.5570	2017-08-11
KNW	Instrument, Biopsy	Gastroenterology, Urology	Class 2	876.1075	2017-10-26
QGC	Suprapubic Catheter Accessories	Gastroenterology, Urology	Class 1	876.5100	2025-07-31
NNI	Container, Specimen, Non-Sterile	Pathology	Class 1	864.3250	2012-01-06
JOL	Catheter And Tip, Suction	General Hospital	Class 2	880.6740	2008-04-01
NFK	Kit, Repair, Catheter, Hemodialysis	Gastroenterology, Urology	Class 2	876.5540	2010-09-08
PNO	Catheter, Percutaneous, Cutting/Scoring	Cardiovascular	Class 2	870.1250	2018-02-08
FHA	Clamp, Penile	Gastroenterology, Urology	Class 1	876.5160	1994-03-18
GCB	Needle, Catheter	General, Plastic Surgery	Class 1	878.4200	1992-07-25
LJE	Catheter, Nephrostomy	Unknown	Class U	N/A	2008-07-11
GCE	Adaptor, Catheter	General, Plastic Surgery	Class 1	878.4200	2005-06-10
FMI	Needle, Hypodermic, Single Lumen	General Hospital	Class 2	880.5570	2019-11-22
FAS	Electrode, Electrosurgical, Active, Urological	Gastroenterology, Urology	Class 2	876.4300	2007-02-27
FBW	Filiform And Filiform Follower	Gastroenterology, Urology	Class 1	876.5520	2007-03-14
FPA	Set, Administration, Intravascular	General Hospital	Class 2	880.5440	2007-10-22
GEX	Powered Laser Surgical Instrument	General, Plastic Surgery	Class 2	878.4810	2012-08-03
PND	Midline Catheter	General Hospital	Class 2	880.5200	2016-06-28
FKC	Clamp, Cannula	Gastroenterology, Urology	Class 1	876.5540	2012-05-31
EXB	Collector, Ostomy	Gastroenterology, Urology	Class 1	876.5900	1995-06-21
PND	Midline Catheter	General Hospital	Class 2	880.5200	2022-07-28
DYB	Introducer, Catheter	Cardiovascular	Class 2	870.1340	2015-04-15
EZC	Catheter, Coude	Gastroenterology, Urology	Class 2	876.5130	2018-07-25
KRA	Catheter, Continuous Flush	Cardiovascular	Class 2	870.1210	2026-03-26
FOZ	Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days	General Hospital	Class 2	880.5200	2024-09-20
PND	Midline Catheter	General Hospital	Class 2	880.5200	2016-12-15
DQX	Wire, Guide, Catheter	Cardiovascular	Class 2	870.1330	2015-06-16
ITX	Transducer, Ultrasonic, Diagnostic	Radiology	Class 2	892.1570	2017-05-23
LJS	Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days	General Hospital	Class 2	880.5970	2021-08-18
MSD	Catheter, Hemodialysis, Implanted	Gastroenterology, Urology	Class 2	876.5540	2007-10-22
LJT	Port & Catheter, Implanted, Subcutaneous, Intravascular	General Hospital	Class 2	880.5965	2007-10-23
MDM	Instrument, Manual, Surgical, General Use	General, Plastic Surgery	Class 1	878.4800	1994-03-18
DWM	Apparatus, Suction, Patient Care	Cardiovascular	Class 2	870.5050	2011-05-13
KOD	Catheter, Urological	Gastroenterology, Urology	Class 2	876.5130	2007-12-12
OCX	Endoscopic Irrigation/Suction System	Gastroenterology, Urology	Class 2	876.1500	2007-12-10
LJT	Port & Catheter, Implanted, Subcutaneous, Intravascular	General Hospital	Class 2	880.5965	2012-12-11
LJT	Port & Catheter, Implanted, Subcutaneous, Intravascular	General Hospital	Class 2	880.5965	2007-10-23
FEG	Tube, Double Lumen For Intestinal Decompression And/Or Intubation	Gastroenterology, Urology	Class 2	876.5980	2007-02-27
DXO	Transducer, Pressure, Catheter Tip	Cardiovascular	Class 2	870.2870	2026-03-26
MJC	Catheter, Urological (Antimicrobial) And Accessories	Gastroenterology, Urology	Class 2	876.5130	2007-12-07
KOD	Catheter, Urological	Gastroenterology, Urology	Class 2	876.5130	2007-12-07
PTT	Biliary Catheter For Irrigation And Contrast Injection, Exempt	Gastroenterology, Urology	Class 2	876.5010	2017-10-24
EXF	Bag, Bile Collecting	Gastroenterology, Urology	Class 2	876.5010	2007-03-14
EYJ	Holder, Ureteral Catheter	Gastroenterology, Urology	Class 1	876.5130	2008-03-31
KRA	Catheter, Continuous Flush	Cardiovascular	Class 2	870.1210	2026-03-26
DQO	Catheter, Intravascular, Diagnostic	Cardiovascular	Class 2	870.1200	2026-03-27
KRA	Catheter, Continuous Flush	Cardiovascular	Class 2	870.1210	2026-03-27
DYG	Catheter, Flow Directed	Cardiovascular	Class 2	870.1240	2026-03-27
DQE	Catheter, Oximeter, Fiber-Optic	Cardiovascular	Class 2	870.1230	2026-03-27
LJT	Port & Catheter, Implanted, Subcutaneous, Intravascular	General Hospital	Class 2	880.5965	2007-10-23
GDW	Staple, Implantable	General, Plastic Surgery	Class 2	878.4750	2008-11-11
FFH	Collector, Urine, Pediatric, For Indwelling Catheter	Gastroenterology, Urology	Class 2	876.5250	2007-02-27
LJT	Port & Catheter, Implanted, Subcutaneous, Intravascular	General Hospital	Class 2	880.5965	2008-06-19
KRA	Catheter, Continuous Flush	Cardiovascular	Class 2	870.1210	2026-03-26
DXE	Catheter, Embolectomy	Cardiovascular	Class 2	870.5150	2026-03-26
LJT	Port & Catheter, Implanted, Subcutaneous, Intravascular	General Hospital	Class 2	880.5965	2007-10-23
KPM	Shunt, Peritoneal	Gastroenterology, Urology	Class 2	876.5955	2025-09-12
FTL	Mesh, Surgical, Polymeric	General, Plastic Surgery	Class 2	878.3300	2025-06-16
NEU	Marker, Radiographic, Implantable	General, Plastic Surgery	Class 2	878.4300	2016-06-14
KRA	Catheter, Continuous Flush	Cardiovascular	Class 2	870.1210	2026-03-26
DXO	Transducer, Pressure, Catheter Tip	Cardiovascular	Class 2	870.2870	2026-03-26
QMS	Adjunctive Open Loop Fluid Therapy Recommender	Cardiovascular	Class 2	870.5600	2026-03-26
DQK	Computer, Diagnostic, Programmable	Cardiovascular	Class 2	870.1425	2026-03-26
FLL	Continuous Measurement Thermometer	General Hospital	Class 2	880.2910	2026-03-26
DXN	System, Measurement, Blood-Pressure, Non-Invasive	Cardiovascular	Class 2	870.1130	2026-03-26
QAQ	Adjunctive Predictive Cardiovascular Indicator	Cardiovascular	Class 2	870.2210	2026-03-26
DQE	Catheter, Oximeter, Fiber-Optic	Cardiovascular	Class 2	870.1230	2026-03-26
MUD	Oximeter, Tissue Saturation	Cardiovascular	Class 2	870.2700	2026-03-26
DSB	Plethysmograph, Impedance	Cardiovascular	Class 2	870.2770	2026-03-26
LJS	Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days	General Hospital	Class 2	880.5970	2007-10-22
CBH	Device, Fixation, Tracheal Tube	Anesthesiology	Class 1	868.5770	2009-04-24
LJS	Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days	General Hospital	Class 2	880.5970	2018-08-15
LWE	Bone Marrow Collection/Transfusion Kit	Unknown	Class 2	N/A	2019-06-05
EZD	Catheter, Straight	Gastroenterology, Urology	Class 2	876.5130	2018-01-25
PXU	Fluid Drainage Tray	General, Plastic Surgery	Class 1	878.4200	2023-01-13
NFK	Kit, Repair, Catheter, Hemodialysis	Gastroenterology, Urology	Class 2	876.5540	2007-10-23
LJT	Port & Catheter, Implanted, Subcutaneous, Intravascular	General Hospital	Class 2	880.5965	2007-10-23
EZL	Catheter, Retention Type, Balloon	Gastroenterology, Urology	Class 2	876.5130	2007-12-07
BSS	Tube, Nasogastric	Gastroenterology, Urology	Class 2	876.5980	2011-12-07
LJS	Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days	General Hospital	Class 2	880.5970	2007-10-22
FPA	Set, Administration, Intravascular	General Hospital	Class 2	880.5440	2007-12-07
LJS	Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days	General Hospital	Class 2	880.5970	2011-09-08
FPA	Set, Administration, Intravascular	General Hospital	Class 2	880.5440	2011-08-03
EZL	Catheter, Retention Type, Balloon	Gastroenterology, Urology	Class 2	876.5130	2007-03-14
GDF	Guide, Needle, Surgical	General, Plastic Surgery	Class 1	878.4800	2003-10-31
KOE	Dilator, Urethral	Gastroenterology, Urology	Class 2	876.5520	2008-02-13
FPA	Set, Administration, Intravascular	General Hospital	Class 2	880.5440	2010-09-08
FPA	Set, Administration, Intravascular	General Hospital	Class 2	880.5440	2007-12-07
KNY	Accessories, Catheter, G-U	Gastroenterology, Urology	Class 2	876.5130	2010-02-22
EZC	Catheter, Coude	Gastroenterology, Urology	Class 2	876.5130	2007-12-07
LJS	Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days	General Hospital	Class 2	880.5970	2007-12-13
FPA	Set, Administration, Intravascular	General Hospital	Class 2	880.5440	2010-09-08
MJC	Catheter, Urological (Antimicrobial) And Accessories	Gastroenterology, Urology	Class 2	876.5130	2007-12-07
MSD	Catheter, Hemodialysis, Implanted	Gastroenterology, Urology	Class 2	876.5540	2021-04-05
LJS	Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days	General Hospital	Class 2	880.5970	2016-06-22
LJS	Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days	General Hospital	Class 2	880.5970	2007-10-22
FAD	Stent, Ureteral	Gastroenterology, Urology	Class 2	876.4620	2009-07-10
IWJ	System, Applicator, Radionuclide, Manual	Radiology	Class 1	892.5650	1999-12-16
KDC	Instrument, Surgical, Disposable	General, Plastic Surgery	Class 1	878.4800	2011-12-07
DXE	Catheter, Embolectomy	Cardiovascular	Class 2	870.5150	2026-03-26
PXI	Thoracentesis Tray	General Hospital	Class 2	880.5570	2024-11-15
EZL	Catheter, Retention Type, Balloon	Gastroenterology, Urology	Class 2	876.5130	2016-07-01
KNX	Collector, Urine, (And Accessories) For Indwelling Catheter	Gastroenterology, Urology	Class 2	876.5250	2016-07-01
KNW	Instrument, Biopsy	Gastroenterology, Urology	Class 2	876.1075	2007-12-05
LIT	Catheter, Angioplasty, Peripheral, Transluminal	Cardiovascular	Class 2	870.1250	2014-09-24
DXE	Catheter, Embolectomy	Cardiovascular	Class 2	870.5150	2026-03-26
PNG	Peritoneal, Drainage Catheter For Refractory Ascites, Long-Term Indwelling	Gastroenterology, Urology	Class 2	876.5630	2025-09-12
NBE	Sealant, Polymerizing	Unknown	Class 3	N/A	2024-02-05
LJS	Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days	General Hospital	Class 2	880.5970	2007-10-22
LDF	Electrode, Pacemaker, Temporary	Cardiovascular	Class 2	870.3680	2026-03-26
FEN	Device, Cystometric, Hydraulic	Gastroenterology, Urology	Class 2	876.1620	2006-03-01
DQY	Catheter, Percutaneous	Cardiovascular	Class 2	870.1250	2007-10-22
MJC	Catheter, Urological (Antimicrobial) And Accessories	Gastroenterology, Urology	Class 2	876.5130	2007-02-27
DWM	Apparatus, Suction, Patient Care	Cardiovascular	Class 2	870.5050	2007-08-24
FCG	Biopsy Needle	Gastroenterology, Urology	Class 2	876.1075	2007-03-14
EZL	Catheter, Retention Type, Balloon	Gastroenterology, Urology	Class 2	876.5130	2018-01-25
KNW	Instrument, Biopsy	Gastroenterology, Urology	Class 2	876.1075	2019-06-05
KOD	Catheter, Urological	Gastroenterology, Urology	Class 2	876.5130	2026-02-25
DRF	Catheter, Electrode Recording, Or Probe, Electrode Recording	Cardiovascular	Class 2	870.1220	2008-01-31
MAV	Syringe, Balloon Inflation	Cardiovascular	Class 2	870.1650	2015-02-02
FPA	Set, Administration, Intravascular	General Hospital	Class 2	880.5440	2007-12-07
FOZ	Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days	General Hospital	Class 2	880.5200	2020-02-10
EZN	Dilator, Catheter, Ureteral	Gastroenterology, Urology	Class 2	876.5470	2007-02-27
LIT	Catheter, Angioplasty, Peripheral, Transluminal	Cardiovascular	Class 2	870.1250	2012-09-27
LDF	Electrode, Pacemaker, Temporary	Cardiovascular	Class 2	870.3680	2008-01-31
FMI	Needle, Hypodermic, Single Lumen	General Hospital	Class 2	880.5570	2019-06-05
LJT	Port & Catheter, Implanted, Subcutaneous, Intravascular	General Hospital	Class 2	880.5965	2025-01-29
GCJ	Laparoscope, General & Plastic Surgery	Gastroenterology, Urology	Class 2	876.1500	2008-01-09
FAQ	Bag, Urine Collection, Leg, For External Use, Sterile	Gastroenterology, Urology	Class 1	876.5250	2007-02-27
FPA	Set, Administration, Intravascular	General Hospital	Class 2	880.5440	2007-05-31
PAH	Mesh, Surgical, Synthetic, Urogynecologic, For Stress Urinary Incontinence, Female, Mini-Sling	General, Plastic Surgery	Class 2	878.3300	2009-12-23
KOD	Catheter, Urological	Gastroenterology, Urology	Class 2	876.5130	2007-12-12
MPB	Catheter, Hemodialysis, Non-Implanted	Gastroenterology, Urology	Class 2	876.5540	2007-10-22
KYR	Bag, Ice	General Hospital	Class 1	880.6050	1999-08-05
FAD	Stent, Ureteral	Gastroenterology, Urology	Class 2	876.4620	2007-12-10
LJT	Port & Catheter, Implanted, Subcutaneous, Intravascular	General Hospital	Class 2	880.5965	2008-01-15
NIE	Catheter, Hemodialysis, Triple Lumen, Non-Implanted	Gastroenterology, Urology	Class 2	876.5540	2015-06-19
NEU	Marker, Radiographic, Implantable	General, Plastic Surgery	Class 2	878.4300	2008-11-11
GDW	Staple, Implantable	General, Plastic Surgery	Class 2	878.4750	2008-11-11
NNW	Bag, Urine Collection, Leg, For External Use, Non-Sterile	Gastroenterology, Urology	Class 1	876.5250	2009-03-13
LJS	Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days	General Hospital	Class 2	880.5970	2017-10-11
KNT	Tubes, Gastrointestinal (And Accessories)	Gastroenterology, Urology	Class 2	876.5980	2007-11-27
LJE	Catheter, Nephrostomy	Unknown	Class U	N/A	2009-04-14
DQY	Catheter, Percutaneous	Cardiovascular	Class 2	870.1250	2021-07-28
NZU	Collector, Urine, Powered, Non Indwelling Catheter	Gastroenterology, Urology	Class 1	876.5250	2018-01-10
DXO	Transducer, Pressure, Catheter Tip	Cardiovascular	Class 2	870.2870	2026-03-26
BTQ	Airway, Nasopharyngeal	Anesthesiology	Class 1	868.5100	1995-06-21
KYW	Container, Liquid Medication, Graduated	General Hospital	Class 1	880.6430	2014-01-15
DRS	Transducer, Blood-Pressure, Extravascular	Cardiovascular	Class 2	870.2850	2026-03-26
FOZ	Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days	General Hospital	Class 2	880.5200	2007-10-22
MSD	Catheter, Hemodialysis, Implanted	Gastroenterology, Urology	Class 2	876.5540	2020-07-17
KGX	Tape And Bandage, Adhesive	General Hospital	Class 1	880.5240	2008-08-29
KNW	Instrument, Biopsy	Gastroenterology, Urology	Class 2	876.1075	2010-09-02
GEI	Electrosurgical, Cutting & Coagulation & Accessories	General, Plastic Surgery	Class 2	878.4400	2010-09-02
KNW	Instrument, Biopsy	Gastroenterology, Urology	Class 2	876.1075	2019-06-05
DYB	Introducer, Catheter	Cardiovascular	Class 2	870.1340	2007-12-13
EZD	Catheter, Straight	Gastroenterology, Urology	Class 2	876.5130	2018-05-10
DWJ	System, Thermal Regulating	Cardiovascular	Class 2	870.5900	2016-09-07
KOD	Catheter, Urological	Gastroenterology, Urology	Class 2	876.5130	2007-02-27
LIT	Catheter, Angioplasty, Peripheral, Transluminal	Cardiovascular	Class 2	870.1250	2012-04-26
DQY	Catheter, Percutaneous	Cardiovascular	Class 2	870.1250	2012-04-26
LIT	Catheter, Angioplasty, Peripheral, Transluminal	Cardiovascular	Class 2	870.1250	2018-08-06
DQY	Catheter, Percutaneous	Cardiovascular	Class 2	870.1250	2018-08-06
DQO	Catheter, Intravascular, Diagnostic	Cardiovascular	Class 2	870.1200	2026-03-26
QAQ	Adjunctive Predictive Cardiovascular Indicator	Cardiovascular	Class 2	870.2210	2026-03-26
DXN	System, Measurement, Blood-Pressure, Non-Invasive	Cardiovascular	Class 2	870.1130	2026-03-26
DRS	Transducer, Blood-Pressure, Extravascular	Cardiovascular	Class 2	870.2850	2026-03-26
DYG	Catheter, Flow Directed	Cardiovascular	Class 2	870.1240	2026-03-26
DQE	Catheter, Oximeter, Fiber-Optic	Cardiovascular	Class 2	870.1230	2026-03-26
DSB	Plethysmograph, Impedance	Cardiovascular	Class 2	870.2770	2026-03-26
DQK	Computer, Diagnostic, Programmable	Cardiovascular	Class 2	870.1425	2026-03-26
NEU	Marker, Radiographic, Implantable	General, Plastic Surgery	Class 2	878.4300	2008-11-11
GDW	Staple, Implantable	General, Plastic Surgery	Class 2	878.4750	2008-11-11
MJC	Catheter, Urological (Antimicrobial) And Accessories	Gastroenterology, Urology	Class 2	876.5130	2018-01-25
OIE	Urine Collection Kit (Excludes Hiv Testing)	Pathology	Class 1	864.3250	2019-08-07
MSD	Catheter, Hemodialysis, Implanted	Gastroenterology, Urology	Class 2	876.5540	2007-10-22
KOD	Catheter, Urological	Gastroenterology, Urology	Class 2	876.5130	2007-12-07
BTR	Tube, Tracheal (W/Wo Connector)	Anesthesiology	Class 2	868.5730	2007-12-07
OZT	Balloon Aortic Valvuloplasty	Cardiovascular	Class 2	870.1255	2015-06-18
GFD	Dermatome	General, Plastic Surgery	Class 1	878.4820	2007-02-27
DQY	Catheter, Percutaneous	Cardiovascular	Class 2	870.1250	2014-01-29
LIT	Catheter, Angioplasty, Peripheral, Transluminal	Cardiovascular	Class 2	870.1250	2014-01-29
EXS	Urinometer, Electrical	Gastroenterology, Urology	Class 2	876.1800	2012-02-24
DSY	Prosthesis, Vascular Graft, Of 6mm And Greater Diameter	Cardiovascular	Class 2	870.3450	2007-11-30
HTD	Forceps	General, Plastic Surgery	Class 1	878.4800	2012-01-06
GBM	Catheter, Urethral	Gastroenterology, Urology	Class 2	876.5130	2018-07-25
GAA	Needle, Aspiration And Injection, Disposable	General, Plastic Surgery	Class 1	878.4800	1998-03-19
PAI	Mesh, Surgical, Non-Synthetic, Urogynecologic, For Pelvic Organ Prolapse, Transvaginally Placed	Obstetrics/Gynecology	Class 3	884.5980	2008-12-12
OTP	Mesh, Surgical, Synthetic, Urogynecologic, For Pelvic Organ Prolapse, Transvaginally Placed	Obstetrics/Gynecology	Class 3	884.5980	2008-12-12
FCG	Biopsy Needle	Gastroenterology, Urology	Class 2	876.1075	2007-03-14
MMX	Device, Percutaneous Retrieval	Cardiovascular	Class 2	870.5150	2016-08-30
EZC	Catheter, Coude	Gastroenterology, Urology	Class 2	876.5130	2007-03-14
LJS	Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days	General Hospital	Class 2	880.5970	2007-10-22
OTN	Mesh, Surgical, Synthetic, Urogynecologic, For Stress Urinary Incontinence, Retropubic Or Transobturator	General, Plastic Surgery	Class 2	878.3300	2014-03-28
MJC	Catheter, Urological (Antimicrobial) And Accessories	Gastroenterology, Urology	Class 2	876.5130	2014-10-26
EZN	Dilator, Catheter, Ureteral	Gastroenterology, Urology	Class 2	876.5470	2007-02-27
DXE	Catheter, Embolectomy	Cardiovascular	Class 2	870.5150	2026-03-26
LIT	Catheter, Angioplasty, Peripheral, Transluminal	Cardiovascular	Class 2	870.1250	2007-12-05
DQY	Catheter, Percutaneous	Cardiovascular	Class 2	870.1250	2007-12-05
FEW	Catheter, Malecot	Gastroenterology, Urology	Class 2	876.5090	2007-12-10
FOZ	Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days	General Hospital	Class 2	880.5200	2014-01-27
NIE	Catheter, Hemodialysis, Triple Lumen, Non-Implanted	Gastroenterology, Urology	Class 2	876.5540	2015-01-05
GDW	Staple, Implantable	General, Plastic Surgery	Class 2	878.4750	2011-06-29
KOD	Catheter, Urological	Gastroenterology, Urology	Class 2	876.5130	2014-10-26
MPB	Catheter, Hemodialysis, Non-Implanted	Gastroenterology, Urology	Class 2	876.5540	2009-03-13
NNX	Device, Incontinence, Urosheath Type, Non-Sterile	Gastroenterology, Urology	Class 1	876.5250	2014-10-26
KNW	Instrument, Biopsy	Gastroenterology, Urology	Class 2	876.1075	2022-03-30
LJT	Port & Catheter, Implanted, Subcutaneous, Intravascular	General Hospital	Class 2	880.5965	2007-10-22
KQT	Evacuator, Gastro-Urology	Gastroenterology, Urology	Class 2	876.4370	2007-02-27
PAI	Mesh, Surgical, Non-Synthetic, Urogynecologic, For Pelvic Organ Prolapse, Transvaginally Placed	Obstetrics/Gynecology	Class 3	884.5980	2007-12-10
OTP	Mesh, Surgical, Synthetic, Urogynecologic, For Pelvic Organ Prolapse, Transvaginally Placed	Obstetrics/Gynecology	Class 3	884.5980	2007-12-10
LJS	Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days	General Hospital	Class 2	880.5970	2007-10-22
FAS	Electrode, Electrosurgical, Active, Urological	Gastroenterology, Urology	Class 2	876.4300	2007-02-27
FED	Endoscopic Access Overtube, Gastroenterology-Urology	Gastroenterology, Urology	Class 2	876.1500	2016-04-25
PND	Midline Catheter	General Hospital	Class 2	880.5200	2017-06-02
DYB	Introducer, Catheter	Cardiovascular	Class 2	870.1340	2026-05-28
LDF	Electrode, Pacemaker, Temporary	Cardiovascular	Class 2	870.3680	2026-05-28
EYI	Adaptor, Ureteral Catheter	Gastroenterology, Urology	Class 1	876.5130	2025-07-31
DSA	Cable, Transducer And Electrode, Patient, (Including Connector)	Cardiovascular	Class 2	870.2900	2008-02-08
LJS	Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days	General Hospital	Class 2	880.5970	2012-04-10
FOZ	Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days	General Hospital	Class 2	880.5200	2020-04-15
EZL	Catheter, Retention Type, Balloon	Gastroenterology, Urology	Class 2	876.5130	2019-06-14
MMX	Device, Percutaneous Retrieval	Cardiovascular	Class 2	870.5150	2016-03-24
DXZ	Patch, Pledget And Intracardiac, Petp, Ptfe, Polypropylene	Cardiovascular	Class 2	870.3470	2010-04-13
FBM	Cannula And Trocar, Suprapubic, Non-Disposable	Gastroenterology, Urology	Class 1	876.5090	2014-07-09
PHU	Intra-Abdominal Pressure Monitoring Device	Unknown	Class U	N/A	2007-09-07
EZL	Catheter, Retention Type, Balloon	Gastroenterology, Urology	Class 2	876.5130	2007-12-07
NEU	Marker, Radiographic, Implantable	General, Plastic Surgery	Class 2	878.4300	2018-03-15
LJT	Port & Catheter, Implanted, Subcutaneous, Intravascular	General Hospital	Class 2	880.5965	2007-10-23
FSH	Tray, Surgical, Needle	General, Plastic Surgery	Class 1	878.4800	2019-06-05
FCG	Biopsy Needle	Gastroenterology, Urology	Class 2	876.1075	2019-06-05
FTM	Mesh, Surgical	General, Plastic Surgery	Class 2	878.3300	2007-08-02
DYB	Introducer, Catheter	Cardiovascular	Class 2	870.1340	2007-10-22
EZD	Catheter, Straight	Gastroenterology, Urology	Class 2	876.5130	2015-06-12
FPA	Set, Administration, Intravascular	General Hospital	Class 2	880.5440	2007-10-22
MSD	Catheter, Hemodialysis, Implanted	Gastroenterology, Urology	Class 2	876.5540	2021-06-07
MPB	Catheter, Hemodialysis, Non-Implanted	Gastroenterology, Urology	Class 2	876.5540	2007-10-22
FMI	Needle, Hypodermic, Single Lumen	General Hospital	Class 2	880.5570	2017-03-06
MJC	Catheter, Urological (Antimicrobial) And Accessories	Gastroenterology, Urology	Class 2	876.5130	2008-01-07
EZL	Catheter, Retention Type, Balloon	Gastroenterology, Urology	Class 2	876.5130	2008-01-07
LJT	Port & Catheter, Implanted, Subcutaneous, Intravascular	General Hospital	Class 2	880.5965	2025-09-16
FTL	Mesh, Surgical, Polymeric	General, Plastic Surgery	Class 2	878.3300	2008-01-09
KOD	Catheter, Urological	Gastroenterology, Urology	Class 2	876.5130	2007-12-07
FFL	Dislodger, Stone, Basket, Ureteral, Metal	Gastroenterology, Urology	Class 2	876.4680	1999-12-16
LJS	Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days	General Hospital	Class 2	880.5970	2007-10-22
PVZ	Non-Stainless Steel Needle	General Hospital	Class 2	880.5570	2017-06-29
GBX	Catheter, Irrigation	General, Plastic Surgery	Class 1	878.4200	1999-04-14
LJS	Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days	General Hospital	Class 2	880.5970	2007-10-22
LJS	Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days	General Hospital	Class 2	880.5970	2007-10-22
ITX	Transducer, Ultrasonic, Diagnostic	Radiology	Class 2	892.1570	2008-05-09
EZL	Catheter, Retention Type, Balloon	Gastroenterology, Urology	Class 2	876.5130	2007-12-07
FFG	Device, Urine Flow Rate Measuring, Non-Electrical, Disposable	Gastroenterology, Urology	Class 2	876.1800	2007-02-27
DWJ	System, Thermal Regulating	Cardiovascular	Class 2	870.5900	2015-01-08
LJS	Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days	General Hospital	Class 2	880.5970	2010-02-12
DTK	Filter, Intravascular, Cardiovascular	Cardiovascular	Class 2	870.3375	2024-03-04
FOZ	Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days	General Hospital	Class 2	880.5200	2007-10-22
KNW	Instrument, Biopsy	Gastroenterology, Urology	Class 2	876.1075	2025-07-28
DQE	Catheter, Oximeter, Fiber-Optic	Cardiovascular	Class 2	870.1230	2026-03-26
DWM	Apparatus, Suction, Patient Care	Cardiovascular	Class 2	870.5050	2025-01-30
FOZ	Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days	General Hospital	Class 2	880.5200	2017-01-10
FCM	Tray, Catheterization, Sterile Urethral, With Or Without Catheter (Kit)	Gastroenterology, Urology	Class 2	876.5130	2007-03-14
DRS	Transducer, Blood-Pressure, Extravascular	Cardiovascular	Class 2	870.2850	2026-03-26
GDW	Staple, Implantable	General, Plastic Surgery	Class 2	878.4750	2008-11-11
FZP	Clip, Implantable	General, Plastic Surgery	Class 2	878.4300	2008-11-11
LJT	Port & Catheter, Implanted, Subcutaneous, Intravascular	General Hospital	Class 2	880.5965	2007-12-13
FPA	Set, Administration, Intravascular	General Hospital	Class 2	880.5440	2007-12-13
ITX	Transducer, Ultrasonic, Diagnostic	Radiology	Class 2	892.1570	2007-10-23
FTL	Mesh, Surgical, Polymeric	General, Plastic Surgery	Class 2	878.3300	2008-01-09
FZX	Guide, Surgical, Instrument	General, Plastic Surgery	Class 1	878.4800	1997-05-28
GBM	Catheter, Urethral	Gastroenterology, Urology	Class 2	876.5130	2007-02-27
LJS	Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days	General Hospital	Class 2	880.5970	2009-08-26
MPB	Catheter, Hemodialysis, Non-Implanted	Gastroenterology, Urology	Class 2	876.5540	2015-11-19
LJS	Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days	General Hospital	Class 2	880.5970	2007-10-22
KNT	Tubes, Gastrointestinal (And Accessories)	Gastroenterology, Urology	Class 2	876.5980	2016-04-05
EXF	Bag, Bile Collecting	Gastroenterology, Urology	Class 2	876.5010	2025-07-31
PDU	Catheter For Crossing Total Occlusions	Cardiovascular	Class 2	870.1250	2021-08-13
LIT	Catheter, Angioplasty, Peripheral, Transluminal	Cardiovascular	Class 2	870.1250	2013-06-07
DXZ	Patch, Pledget And Intracardiac, Petp, Ptfe, Polypropylene	Cardiovascular	Class 2	870.3470	2006-05-15
LJS	Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days	General Hospital	Class 2	880.5970	2005-12-27
DRF	Catheter, Electrode Recording, Or Probe, Electrode Recording	Cardiovascular	Class 2	870.1220	2008-01-31
DXC	Clamp, Vascular	Cardiovascular	Class 2	870.4450	2026-03-26
DYB	Introducer, Catheter	Cardiovascular	Class 2	870.1340	2008-08-22
LJT	Port & Catheter, Implanted, Subcutaneous, Intravascular	General Hospital	Class 2	880.5965	2007-10-23
FCN	Urinary Drainage Collection Kit, For Indwelling Catheter	Gastroenterology, Urology	Class 2	876.5250	1992-07-22
LIT	Catheter, Angioplasty, Peripheral, Transluminal	Cardiovascular	Class 2	870.1250	2023-01-26
PAG	Mesh, Surgical, Non-Synthetic, Urogynecologic, For Stress Urinary Incontinence, Retropubic Or Transobturator	General, Plastic Surgery	Class 2	878.3300	2007-02-27
FKA	Dilator, Vessel	Gastroenterology, Urology	Class 2	876.5540	2007-10-22
OTO	Mesh, Surgical, Synthetic, Urogynecologic, For Apical Vaginal And Uterine Prolapse, Transabdominally Placed	General, Plastic Surgery	Class 2	878.3300	2011-04-13
LJS	Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days	General Hospital	Class 2	880.5970	2007-10-22
DYF	Prosthesis, Vascular Graft, Of Less Then 6mm Diameter	Cardiovascular	Class 2	870.3450	2007-03-14
PNG	Peritoneal, Drainage Catheter For Refractory Ascites, Long-Term Indwelling	Gastroenterology, Urology	Class 2	876.5630	2025-01-09
OXQ	Dressing Change Tray	General Hospital	Class 1	880.5075	2016-02-26
LJS	Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days	General Hospital	Class 2	880.5970	2010-11-22
DRE	Dilator, Vessel, For Percutaneous Catheterization	Cardiovascular	Class 2	870.1310	2026-03-27
DXG	Computer, Diagnostic, Pre-Programmed, Single-Function	Cardiovascular	Class 2	870.1435	2026-03-27
DQE	Catheter, Oximeter, Fiber-Optic	Cardiovascular	Class 2	870.1230	2026-03-27
LJS	Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days	General Hospital	Class 2	880.5970	2007-10-22
KOD	Catheter, Urological	Gastroenterology, Urology	Class 2	876.5130	2007-12-07
KMK	Device, Intravascular Catheter Securement	General Hospital	Class 1	880.5210	2006-10-31
LJS	Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days	General Hospital	Class 2	880.5970	2007-10-22
DYF	Prosthesis, Vascular Graft, Of Less Then 6mm Diameter	Cardiovascular	Class 2	870.3450	2007-12-05
LJS	Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days	General Hospital	Class 2	880.5970	2007-10-22
FTL	Mesh, Surgical, Polymeric	General, Plastic Surgery	Class 2	878.3300	2010-02-01
ITX	Transducer, Ultrasonic, Diagnostic	Radiology	Class 2	892.1570	2007-12-10
EYA	Stylet, Ureteral	Gastroenterology, Urology	Class 1	876.5130	2014-11-04
MJN	Catheter, Intravascular Occluding, Temporary	Cardiovascular	Class 2	870.4450	2026-03-26
MSD	Catheter, Hemodialysis, Implanted	Gastroenterology, Urology	Class 2	876.5540	2020-11-18
MSD	Catheter, Hemodialysis, Implanted	Gastroenterology, Urology	Class 2	876.5540	2009-03-13

Official Correspondent

No official correspondent registered.

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

C. R. Bard, Inc.

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Other Registrations for Same Entity

Registration Number	Establishment Name	Location
1725056	MEDIVANCE, INC.	LOUISVILLE, CO, US
3006513822	Lutonix, Inc.	Tempe, AZ, US
1223089	DAVOL INC.	WOBURN, MA, US
3002504068	Bard European Distribution Center NV	Olen Antwerpen, BE
1213643	DAVOL INC., SUB. C.R. BARD, INC.	Warwick, RI, US

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K172344	Medax Srl Unipersonale	Medax Biopsy Systems II (MEDONE, MEDCUT, MEDEM, MEDBONE, MEDLOCK)	2017-11-13
K220566	Koag, LLC	Vascette HP (hemostatic pad)	2022-07-29
K080818	Hem Con Medical Technologies, Inc.	HEMCON BANDAGE, HEMCON BANDAGE OTC, HEMCON CHITOFLEX-SURGICAL DRESSING	2008-05-15
K893123	Les Laboratorires Brothier, S.A.	ADHESIVE BANDAGES & PADS FOR MINOR CUTS/SCRAPES	1990-02-13
K143462	Benq Materials Corporation	AnsCare ChitoClot Gauze (prescription use), AnsCare ChitoClot Gauze (over-the-counter use)	2015-05-08

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0010-2013	C.R. Bard, Inc., Urological Division	2	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 to provide continuous urinary drainage from the bladder.
Z-0027-2024	Bard Peripheral Vascular Inc	2	Bard Marquee Disposable Core Biopsy Instrument Kit, REF: MQK2016
Z-0028-2013	Remington Medical Inc.	2	Automatic Cutting Needles, Soft Tissue Biopsy Needle, NAC-1820M, Sterile, Remington Medical, Inc., 5830 Meadowridge Court, Alpharetta, GA 30005. Prostate Biopsy Needles shall be single use only and are to be used by a Urologist in a healthcare setting to obtain needle biopsies of the prostate. The needles are compatible with the Bard Magnum biopsy instrument. The needles have an echogenic tip for accurate placement under ultrasound guidance and centimeter markings along the cannula to facilitate depth placement.
Z-0042-2014	Atossa Genetics, Inc.	2	Brand: The ForeCYTE Breast Health Test, Mammary Aspiration Specimen Cytology Test (MASCT), MASCT System Kits, Clarity System Kits, MASCT Patient Sample Kits & Clarity Patient Sample Kits Instrument, Biopsy. The MASCT System Kit, Patient Sample Kits, or the Nipple Aspirate Fluid Laboratory Kit has the following codes: PRODUCT CODE: AG-MASCT; AG-FC5; DTG-MASCT, DTG-FC5, and NRLBH-5. PART NUMBER: 9002513; 9002513MD; 9002528; 9002528MD; 9002587; 9002614; and 9002717MD. THE MASCT SYSTEM KIT CONSISTS OF: 1. MASCT Breast Pump; 2. Instructions for Use (IFU); 3. Heating Pad; 4. Timer; 5. Saccomono's Fixative; 6. Nu Prep Gel; 7. Welcome and Training Materials Coversheet; 8. MASCT System Order Form; 9. ForeCYTE Training Video DVD; 10. MASCT System Instructions with pictures - pink; THE PATIENT SAMPLE KIT CONSISTS OF: 1. Two (2) flower assemblies (e.g., filter, filter retainer, and filter holder); 2. Instructions for Use (IFU); 3. Two (2) specimen collection devices; 4. Two (2) breast bags for transporting the specimen collection container; 5. Barcode labels; 6. Saccomono's Fixative; 7. Nu Prep Gel; 8. MASCT System package insert; 9. ForeCYTE Test Requisition Form; 10. Patient Information Sheet; 11. Atossa Patient Information; 12. FED EX Clinical PAK; 13. MASCT System Order Form; 14. FED EX Pouch; 15. FED EX Airbill; Product Usage: The MASCT Device is intended for use in the collection of nipple aspirate fluid for cytological testing. The collected fluid can be used in the determination and/or differentiation of normal versus premalignant versus malignant cells.
Z-0044-2018	Bard Peripheral Vascular Inc	2	BARD MAX-CORE Disposable Core Biopsy Instrument, Product Codes - MC1410, 14 g x 10 cm; MC1616, 16 g x 16 cm; MC1816, 18 g x 16 cm; MC1820, 18 g x 20 cm; MC1825, 18 g x 25 cm. The core needle biopsy device is intended for use in obtaining biopsies from soft tissues.

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 1018233. Last updated year: 2026. Please use registration number 1018233 when referencing this establishment in official correspondence.