BEUDAMED
    FDA Registration Active 🇺🇸 United States

    BAXTER HEALTHCARE CORPORATION

    Reg #: 1416980 · FEI: 1416980 · Expires 2026
    View on FDA
    Products
    58
    Proprietary Names
    198
    Establishment Types
    3
    Classifications
    58

    Registration Details

    Registration Name
    BAXTER HEALTHCARE CORPORATION
    Registration Number
    1416980
    FEI Number
    1416980
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    25212 W. ILLINOIS ROUTE 120
    City
    ROUND LAKE
    State
    IL
    ZIP
    60073
    Country
    US

    Regulatory Submissions

    510(k) Number
    K014088
    PMA Number
    P950034

    Owner / Operator

    Firm Name
    BAXTER HEALTHCARE CORPORATION
    Operator Number
    1417572
    Address
    One Baxter Parkway
    City
    Deerfield
    State
    IL
    Postal Code
    60015
    Country
    US
    Correspondent
    Maha Nolasco

    Products

    Device Name Product Code
    Syringe, Irrigating (Non Dental) KYZ
    Syringe, Piston FMF
    Apparatus, Suction, Single Patient Use, Portable, Nonpowered GCY
    System/Device, Pharmacy Compounding NEP
    Set, Administration, Intravascular FPA
    Filler, Bone Void, Calcium Compound MQV
    Patch, Pledget And Intracardiac, Petp, Ptfe, Polypropylene DXZ
    Mesh, Surgical FTM
    Mesh, Surgical, Non-Synthetic, Urogynecologic, For Apical Vaginal And Uterine Prolapse, Transabdominally Placed PAJ
    Mesh, Surgical, Collagen, Thoracic, Chest Wall Reconstruction OXB
    Mesh, Surgical, Collagen, Staple Line Reinforcement OXE
    Bone Grafting Material, Synthetic LYC
    Infusion Safety Management Software PHC
    Pump, Infusion FRN
    Equipment, Laboratory, General Purpose, Labeled Or Promoted For A Specific Medical Use LXG
    Clamp, Vascular DXC
    Transducer, Ultrasonic, Diagnostic ITX
    System, Imaging, Pulsed Doppler, Ultrasonic IYN
    Administrations Sets With Neuraxial Connectors PWH
    Flowmeter, Blood, Cardiovascular DPW
    Device, Anastomotic, Microvascular MVR
    Barrier, Absorbable, Adhesion MCN
    Wax, Bone MTJ
    Set, I.V. Fluid Transfer LHI
    Pump, Infusion, Elastomeric MEB
    Sterilization Wrap Containers, Trays, Cassettes & Other Accessories KCT
    Clip, Implantable FZP
    Container, I.V. KPE
    Set, Blood Transfusion BRZ
    Laparoscope, General & Plastic Surgery GCJ
    Filter, Infusion Line FPB
    Stopcock, I.V. Set FMG
    Dilator, Vessel, Surgical DWP
    System, Skin Closure MKY
    Absorbable Collagen Hemostatic Agent With Thrombin PMX
    Agent, Absorbable Hemostatic, Collagen Based LMF
    Instrument, Manual, Surgical, General Use MDM
    Ophthalmoscope, Battery-Powered HLJ
    Dispenser, Liquid Medication KYX
    Computer, Diagnostic, Pre-Programmed, Single-Function DXG
    Forceps HTD
    Sealant, Polymerizing NBE
    Block, Heating JRG
    Pump, Infusion, Enteral LZH
    Agent, Absorbable Hemostatic, Non-Collagen Based LMG
    Intracardiac Patch Or Pledget, Biologically Derived PSQ
    Dura Substitute GXQ
    Adaptor, Ureteral Catheter EYI
    System, Processing For Frozen Blood KSW
    Polymer, Ent Synthetic-Polyamide (Mesh Or Foil Material) KHJ
    Otoscope ERA
    Applier, Surgical, Clip GDO
    Stand, Instrument, Ophthalmic, Battery Powered NOI
    Stand, Infusion FOX
    Arthroscope HRX
    System, Irrigation, Urological LJH
    Accessories, Catheter KGZ
    Regulator, Pressure, Gas Cylinder CAN

    Proprietary Names

    Recothrom Irrigating (Non-Dental) Syringe - Ear Wash System and accessories DuploReach Evacuated Container None MICROMIX BCR COMPOUNDER All-In-One Two Chamber Container Automix 3+3/AS Compounder System REPEATER PUMP Extension Set MICROMIX COMPOUNDER AN Abacus Luer Lock Universal Spike EM2400 Pharmacy Compounder INTELLIFILL I.V. ExactaMix Pro 2400 Display Module - Refurbished ExactaMix Pro 2400 Display Module ExactaMix Pro 1200 Display Module - Refurbished ExactaMix Pro 1200 Display Module LOGIX Transfer Set REPEATER PUMP Tube Sets AUTOMIX 3+3 COMPOUNDER Duo-Vent Clearlink Interlink Solutions Administration Sets with 0.2 Micron Filter Continu-Flo ALTAPORE PERI-GUARD and SUPPLE PERI-GUARD Duoset Duploject Duplocath Veritas Collagen Matrix Actifuse Spectrum IQ Infusion System with Dose IQ Safety Software Buretrol Buretrol Solution Sets Spectrum IQ Infusion System with Dose IQ Safety Software (3570009) Galaxy Mini-Bag Plus MINIBAG PLUS CONTAINER REPEATER PUMP Tube Sets and Connectors Dispencing Pins RAPIDFILL Infusion Set Flo-Thru Gem Flow Now (GEM2770-FN) PCEA Syringe Set GEM Flow Coupler Device and System Flo-Rester PERI-STRIPS Dry Staple Line Reinforcement with VERITAS Collagen Matrix with SECURE GRIP Technology Sub-Q-Set Subcutaneous Infusion Set Sub-Q-Set Seprafilm Actifuse ABX; Actifuse MIS; Actifuse Shape; ALTAPORE; ALTAPORE SHAPE; ALTAPORE MIS Ostene PCA Syringe Sets Solution Set w/1.2 Micron Air Eliminating Filter RAPIDFILL Tube Set Non-DEHP IV Fat Emulsion Administration Sets DUPLOJECT EASY-PREP SYSTEM Multirate Infusor LV Multirate Infusor SV Baxter Pain Mate Pain Mgt System GEM FLOW COUPLER Monitor (GEM2010M-1) GEM Flow COUPLER Monitor Power Cord Peri-Strips Dry with Veritas Instrument Trays GEM ZIPCLIP Microvascular Anastomotic Device GEM Biover Clamps Actifuse Flow Paclitaxel Sets Aviva Viaflex Additive Cap Interlink Universal Vial Adapter Bard Epidural Spike Tubing Set Valve Controller & Tube Sets for MICROMACRO Compounder Blood Administration Sets 3 Lead Ext w/2 Interlink Inject Sit 3 Port Adapter Dose IQ Safety Software EASYGRIP FLO-41 Precision MIS Delivery System Solution Administration Sets Micro-Volume MICRO-VOLUME Extension Set Flo-Rester Vessel Sizer DermaClose Continous External Tissue Expander DermaClose XL Continuous External Tissue Expander Floseal EXACTAMIX EVA TPN Bags Tubing Sets for Pharmacy Compounder Anastomotic Instrument Ophthalmoscope, battery-powered Vascular Probe NEOTHRIVE Oral Liquid Dispenser EXACTAMED KWIK VIAL ADAPTACAP EXACTAMED Oral Dispenser Oral Liquid Bottle Adapter NICOM Electrodes Prewired Electrode of Cheetah Medical Starling Sensors Electrode Cheetah Sensors Baxter Starling Sensor Pre-wired NICOM Sensor NICOM sensor Actifuse ABX Solution Sets, Extension Sets Clearlink Luer Activated Valve Forceps Vascu-Guard Stopcock and I.V. Solution Administration Sets with Stopcocks Coseal Surgical Sealant Fibrinotherm Novum IQ Syringe Pump IntraVia Container Empty IntraVia PerClot Polysaccharide Hemostatic System Peri-Strips Dry with Veritas Collagen Matrix with Secure Grip Techonology (PSDV-SG) Tissomat and Spray Set Interlink System Intravascular Administration Sets Clearlink System Solution Set Vascu-Guard Vascular Repair Patch Intravascular Administration Sets with Stopcock and Manifold Neutral Luer Activated Device (One-Link Needle-free IV Connector) and Extension Sets with One-Link Needle-free IV Connec One-Link Actifuse Shape Dura-Guard-Dural Repair Patch Solution Set Secondary Medication Set ContinuFlo Solution Set Control-A-Flo Intravascular Extension Sets and Accessories I.V. Administration Set with Control-A-Flo Regulator Blood Administration Set Sterile Luer Lock-to-Urethral Tip Adapter Sterile Luer Lock-to-Catheter Tip Adapter VIAL-MATE Reconstitution Device Vial-Mate Solution Set for Epidural Use Glycerolyte 57 Solution Processing Solution SiGMA Spectrum Infusion Pump with Master Drug Library Blood Recipient Set FENWAL BLOOD RECIPIENT SET Radiation Sterilized Extension Sets Mini-Infuser Digital MacroView, MacroView, 3.5V Diagnostic, Pneumatic, Op77E-Rating, PocketScope, Pocket Jr. Welch Allyn MacroView Plus Oto for iEx Welch Allyn MacroView Plus iExaminer Kit Welch Allyn LumiView Clear Single-Use Ear Specula Pocket LED Otoscopes (multi-colors) and accessories Welch Allyn LED Otoscope Compacset Portable Dignostic Set, Lumiview w/Various Transformer Sets and Accessories Welch Allyn MacroView Basic Otoscope Reusable and Disposable Specula,Dispensers Otoscope and Accessories BLK Pocket LED Otoscope PERI-GUARD Repair Patch, Supple PERI-GUARD Repair Patch Altapore MIS Welch Allyn Universal Desk Charger with Lithium-ion Handles 719-USB USB POWER SUPPLY,5V,1.4A,USB-A 719-3 Li-Ion Plus USB Handle for Desk Charger 719-DSK Welch Allyn Universal Desk Charger Duo Set Due Set A Peri-Guard, Supple Peri-Guard SIGMA Spectrum Infusion Pump with Master Drug Library PreveLeak Novum IQ Hub Allen Adept Solution Set with 1.2 Micron Air Eliminating Filter TUR Irrigation Set Cystoscopy Irrigation Set Arthroscopic Irrigation Set Uromatic Arthromatic Altapore Shape Interlink System T-Connector ExtSet EXACTAMIX Valve Sets & Inlets Malleable Applicator Tip Intravascular Extension Set (Light Resistant Extension Set) Dual Luer Lock Cap CHEMO-AIDE DISPENSING PIN EasySpray ARS-530 Air Regulator System Nitroglycerin Set with DUO-VENT Spike Interlink System T Connector Ext Se Novum IQ Large Volume Pump Spray Set for Tisseel

    Establishment Types

    Complaint File Establishment per 21 CFR 820.198 Develop Specifications But Do Not Manufacture At This Facility Manufacture Medical Device