Baxter Healthcare Corporation

Country not established FDA establishment FEI 2025695

Devices: 61
Registrations: FDA
FDA recalls: 0

Catalogue61

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Company details

FDA FEI number: 2025695
Address: 17511 Armstrong Ave, IRVINE, CA, 92614

Frequently asked questions

How many devices does BAXTER HEALTHCARE CORPORATION have in the registry?

The registry currently lists 61 devices for BAXTER HEALTHCARE CORPORATION. Devices recorded under merged duplicate company entries are counted once.

Which registries list BAXTER HEALTHCARE CORPORATION's devices?

Among its 50 most recently registered devices, BAXTER HEALTHCARE CORPORATION has devices listed in FDA 510(k) (50 devices).

What risk classes do BAXTER HEALTHCARE CORPORATION's devices fall under?

Among its 50 most recently registered devices, the classes recorded for BAXTER HEALTHCARE CORPORATION's devices are Class II. Each device page shows its own class and authorisation.

What are the newest devices from BAXTER HEALTHCARE CORPORATION in the registry?

The most recently registered devices listed for BAXTER HEALTHCARE CORPORATION include Solution Administration Sets with 0.2 Micron Filter, Prismaflex System 8.10, Welch Allyn FlexiPort Blood Pressure Cuffs (FlexiPort Blood Pressure Cuffs) and Spectrum IQ Infusion System with Dose IQ Safety Software (3570009).

Generated automatically from registry data and not verified by a human reviewer.

This is an FDA establishment record. No EUDAMED registration is known for this company and no recalls are recorded.

Catalogue61

Solution Administration Sets with 0.2 Micron Filter Ref K153158 Open recall

Prismaflex System 8.10 Ref K171671

Welch Allyn FlexiPort Blood Pressure Cuffs (FlexiPort Blood Pressure Cuffs) Ref K251745

Spectrum IQ Infusion System with Dose IQ Safety Software (3570009) Ref K251636 Open recall

Novum IQ Large Volume Pump Ref K211122 Open recall

Altapore Shape Ref K200640

Interlink System Extension Set With Control-A-Flo-Regulatory Clearlink System Extension Set With Control-A-Flo-Regulator Ref K121634

SIGMA Spectrum Infusion Pump with Master Drug Library Ref K251640 Open recall

Novum IQ Syringe Pump (40800BAXUS) Ref K242390 Open recall

Baxter SIGMA Spectrum Infusion Pump with Master Drug Library Ref K230022 Open recall

Solution Set for Epidural Use Ref K161323

Blood Administration Sets Ref K220558

Intravascular Extension Set Ref K210430

Solution Administration Sets Ref K243529 Open recall

Clearlink Luer Activated Valve, Clearlink System Non-Dehp Catheter Extension Sets Ref K112893 Open recall

Infusor Small Volume Elastomeric Infusion Devices Ref K062457

Solution Set with 1.2 Micron Air Eliminating Filter Ref K161808

FlexiCap Disconnect Cap with Povidone-Iodine Solution, MiniCap with Povidone-Iodine Solution Ref K152129 Open recall

Altapore Shape Ref K191513

Meridian Hemodialysis Machine, Model 5M5576 Ref K053539

Novum IQ Syringe Pump Ref K211125 Open recall

Spectrum IQ Infusion System with Dose IQ Safety Software Ref K222048

Theranova Dialyzers, Theranova 400 Dialyzer, Theranova 500 Dialyzer Ref DEN190042

Xenium Xph, Models 110, 130, 150, 170, 190 And 210 Ref K083778

Baxter Infusor Sv (Small Volume); Baxter Infusor Lv (Large Volume) Ref K041738

IV Fat Emulsion Administration Sets Ref K172544

PrisMax System Version 3 Ref K193482 Open recall

Xenium Dialyzer, Models 110, 130, 150, 170, 190 And 210 Ref K062079

Tricos T Resorbable Bone Substitute Ref K073571

15L Cycler Drainage Bag Ref K214016

Altapore Ref K192363

Clearlink System Solution Set Ref K180739 Open recall

PCEA Syringe Set Ref K211649

Actifuse ABX; Actifuse MIS; Actifuse Shape; ALTAPORE; ALTAPORE SHAPE; ALTAPORE MIS Ref K241564

CleanCart A, CleanCart C, AK 98 Hemodialysis Machine Ref K232467 Open recall

Prismaflex ST60 Set, Prismaflex ST100 Set, Prismaflex ST150 set Ref K212216 Open recall

Baxter Sigma Spectrum Infusion Pump With Master Drug Library Ref K133801 Open recall

U9000 Plus Ultrafilter Ref K211035

Spectrum IQ Infusion System with Dose IQ Safety Software Ref K220417

PrismaSATE Ref K162887

Homechoice Claria APD System, Sharesource Connectivity Platform for Use with the Homechoice Claria APD System Ref K201867 Open recall

Actifuse Flow Ref K181306

lntravascular Administration Sets with Stopcock and Manifold Ref K223175

VIAL-MATE Adaptor Ref K142600

Spectrum IQ Infusion System, Dose IQ Safety Software Ref K173084 Open recall

Intravascular Extension Sets and Accessories Ref K242339

Nitroglycerin Sets with DUO-VENT Spike Ref K150860

Solution Set/Extension Set Ref K142011

Spectrum IQ Infusion System with Dose IQ Safety Software Ref K230041 Open recall

Intravascular Administration Sets Ref K203609 Open recall

Company details

Frequently asked questions