Search FDA 510(k) Clearance Records

Use this 510(k) search tool to find FDA medical device clearance records by K-number, device name, manufacturer, product code, or regulatory consultant. Explore individual submissions, review timelines, predicate device information, and links to official FDA records. Search the database for free, with no registration required.

176,583 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

653 results for "Baxter Healthcare Corp"
1–24 of 653
Search insights Median review: 83d Cleared: 100% Top manufacturer: Baxter Healthcare Corp Lead specialty: General Hospital
Cleared May 27, 2026
Helion Viewer Suite
K254265 · LLZ
Videomed Srl ( a Baxter Healthcare...
Radiology · 148d
Cleared Jan 16, 2026
WAVE Clinical Platform (2.0.000)
K250135 · MWI
Baxter Healthcare Corp/ Excel Medical
Cardiovascular · 364d
Cleared Dec 16, 2025
Welch Allyn FlexiPort Blood Pressure Cuffs (FlexiPort Blood Pressure Cuffs)
K251745 · DXQ
Baxter Healthcare Corporation
Cardiovascular · 193d
Cleared Jul 28, 2025
SIGMA Spectrum Infusion Pump with Master Drug Library
K251640 · FRN
Baxter Healthcare Corporation
General Hospital · 60d
Cleared Jul 28, 2025
Spectrum IQ Infusion System with Dose IQ Safety Software (3570009)
K251636 · FRN
Baxter Healthcare Corporation
General Hospital · 60d
Cleared Mar 14, 2025
Solution Administration Sets
K243529 · FPA
Baxter Healthcare Corporation
General Hospital · 120d
Cleared Feb 28, 2025
Intravascular Extension Sets and Accessories
K242339 · FPA
Baxter Healthcare Corporation
General Hospital · 205d
Cleared Sep 05, 2024
Novum IQ Syringe Pump (40800BAXUS)
K242390 · FRN
Baxter Healthcare Corporation
General Hospital · 24d
Cleared Aug 02, 2024
Actifuse ABX
K241564 · MQV
Baxter Healthcare Corporation
Orthopedic · 63d
Cleared Mar 29, 2024
Dose IQ Safety Software
K230665 · PHC
Baxter Healthcare Corporation
General Hospital · 385d
Cleared Mar 29, 2024
Novum IQ Large Volume Pump
K211122 · FRN
Baxter Healthcare Corporation
General Hospital · 1079d
Cleared Mar 22, 2024
The Vest APX System (PVAPX1)
K233441 · BYI
Baxter Healthcare Corportation
Anesthesiology · 156d
Cleared Sep 14, 2023
CleanCart A, CleanCart C, AK 98 Hemodialysis Machine
K232467 · KDI
Baxter Healthcare Corporation
Gastroenterology & Urology · 30d
Cleared Mar 31, 2023
Spectrum IQ Infusion System with Dose IQ Safety Software
K230041 · FRN
Baxter Healthcare Corporation
General Hospital · 84d
Cleared Mar 31, 2023
Baxter SIGMA Spectrum Infusion Pump with Master Drug Library
K230022 · FRN
Baxter Healthcare Corporation
General Hospital · 86d
Cleared Mar 10, 2023
lntravascular Administration Sets with Stopcock and Manifold
K223175 · FMG
Baxter Healthcare Corporation
General Hospital · 150d
Cleared Nov 18, 2022
Hillrom Heart and Respiration Rate Monitoring System powered by EarlySense
K223246 · BZQ
Baxter Healthcare Corproration
Anesthesiology · 29d
Cleared Nov 17, 2022
Blood Administration Sets
K220558 · BRZ
Baxter Healthcare Corporation
General Hospital · 262d
Cleared Oct 03, 2022
PCA Syringe Sets
K212262 · FPA
Baxter Healthcare Corporation
General Hospital · 440d
Cleared Sep 06, 2022
Spectrum IQ Infusion System with Dose IQ Safety Software
K222048 · FRN
Baxter Healthcare Corporation
General Hospital · 56d
Cleared Aug 30, 2022
Novum IQ Syringe Pump
K211125 · FRN
Baxter Healthcare Corporation
General Hospital · 502d
Cleared Aug 30, 2022
Dose IQ Safety Software
K211124 · PHC
Baxter Healthcare Corporation
General Hospital · 502d
Cleared Apr 29, 2022
Spectrum IQ Infusion System with Dose IQ Safety Software
K220417 · FRN
Baxter Healthcare Corporation
General Hospital · 74d
Cleared Apr 01, 2022
Prismaflex ST60 Set, Prismaflex ST100 Set, Prismaflex ST150 set
K212216 · KDI
Baxter Healthcare Corporation
Gastroenterology & Urology · 259d