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

63 results for "Baxter Healthcare Corporation"
25–48 of 63
Search insights Median review: 110d Cleared: 98% Top manufacturer: Baxter Healthcare Corporation Lead specialty: General Hospital
Cleared Sep 30, 2021
Intravascular Administration Sets
K203609 · FPA
Baxter Healthcare Corporation
General Hospital · 294d
Cleared Jun 18, 2021
Intravascular Extension Set
K210430 · FPA
Baxter Healthcare Corporation
General Hospital · 126d
Cleared Jun 10, 2021
Blood Administration Set
K210335 · BRZ
Baxter Healthcare Corporation
General Hospital · 125d
Cleared Nov 19, 2020
Homechoice Claria APD System, Sharesource Connectivity Platform for Use with...
K201867 · FKX
Baxter Healthcare Corporation
Gastroenterology & Urology · 135d
Not Cleared Aug 28, 2020
Theranova Dialyzers, Theranova 400 Dialyzer, Theranova 500 Dialyzer
DEN190042 · QAX
Baxter Healthcare Corporation
Gastroenterology & Urology · 347d
Cleared Jul 20, 2020
Intravascular Extension Sets and Accessories
K192366 · FPA
Baxter Healthcare Corporation
General Hospital · 325d
Cleared Jun 30, 2020
Altapore MIS
K201464 · MQV
Baxter Healthcare Corporation
Orthopedic · 28d
Cleared May 08, 2020
ALTAPORE SHAPE
K200640 · MQV
Baxter Healthcare Corporation
Orthopedic · 58d
Cleared Mar 13, 2020
PrisMax System Version 3
K193482 · KDI
Baxter Healthcare Corporation
Gastroenterology & Urology · 87d
Cleared Jan 09, 2020
Altapore
K192363 · MQV
Baxter Healthcare Corporation
Orthopedic · 132d
Cleared Oct 19, 2019
Altapore Shape
K191513 · MQV
Baxter Healthcare Corporation
Orthopedic · 134d
Cleared May 28, 2019
Clearlink System Solution Set
K180739 · FPA
Baxter Healthcare Corporation
General Hospital · 432d
Cleared Aug 31, 2018
ALTAPORE
K181225 · MQV
Baxter Healthcare Corporation
Orthopedic · 115d
Cleared Aug 17, 2018
Actifuse Flow
K181306 · MQV
Baxter Healthcare Corporation
Orthopedic · 92d
Cleared May 11, 2018
Spectrum IQ Infusion System, Dose IQ Safety Software
K173084 · FRN
Baxter Healthcare Corporation
General Hospital · 224d
Cleared Feb 23, 2018
Prismaflex System 8.10
K171671 · KDI
Baxter Healthcare Corporation
Gastroenterology & Urology · 262d
Cleared Sep 22, 2017
IV Fat Emulsion Administration Sets
K172544 · FPA
Baxter Healthcare Corporation
General Hospital · 30d
Cleared Jun 21, 2017
Solution Set with 1.2 Micron Air Eliminating Filter
K161808 · FPA
Baxter Healthcare Corporation
General Hospital · 355d
Cleared Jan 06, 2017
PrismaSATE
K162887 · KPO
Baxter Healthcare Corporation
Gastroenterology & Urology · 81d
Cleared Dec 19, 2016
Paclitaxel Sets
K160007 · FPA
Baxter Healthcare Corporation
General Hospital · 350d
Cleared Nov 30, 2016
Solution Set for Epidural Use
K161323 · FPA
Baxter Healthcare Corporation
General Hospital · 203d
Cleared Dec 28, 2015
Solution Administration Sets with 0.2 Micron Filter
K153158 · FPA
Baxter Healthcare Corporation
General Hospital · 56d
Cleared Oct 29, 2015
FlexiCap Disconnect Cap with Povidone-Iodine Solution, MiniCap with...
K152129 · KDJ
Baxter Healthcare Corporation
Gastroenterology & Urology · 90d
Cleared Apr 16, 2015
Nitroglycerin Sets with DUO-VENT Spike
K150860 · FPA
Baxter Healthcare Corporation
General Hospital · 15d