Baxter Healthcare Corporation - FDA 510(k) Cleared Devices
61
Total
60
Cleared
1
Denied
61 devices
Cleared
Jun 18, 2021
Intravascular Extension Set
General Hospital
126d
Cleared
Jun 10, 2021
Blood Administration Set
General Hospital
125d
Cleared
Nov 19, 2020
Homechoice Claria APD System, Sharesource Connectivity Platform for Use with...
Gastroenterology & Urology
135d
Not Cleared
Aug 28, 2020
Theranova Dialyzers, Theranova 400 Dialyzer, Theranova 500 Dialyzer
Gastroenterology & Urology
347d
Cleared
Jul 20, 2020
Intravascular Extension Sets and Accessories
General Hospital
325d
Cleared
Jun 30, 2020
Altapore MIS
Orthopedic
28d
Cleared
May 08, 2020
ALTAPORE SHAPE
Orthopedic
58d
Cleared
Mar 13, 2020
PrisMax System Version 3
Gastroenterology & Urology
87d
Cleared
Jan 09, 2020
Altapore
Orthopedic
132d
Cleared
Oct 19, 2019
Altapore Shape
Orthopedic
134d
Cleared
May 28, 2019
Clearlink System Solution Set
General Hospital
432d
Cleared
Aug 31, 2018
ALTAPORE
Orthopedic
115d
Cleared
Aug 17, 2018
Actifuse Flow
Orthopedic
92d
Cleared
May 11, 2018
Spectrum IQ Infusion System, Dose IQ Safety Software
General Hospital
224d
Cleared
Feb 23, 2018
Prismaflex System 8.10
Gastroenterology & Urology
262d
Cleared
Sep 22, 2017
IV Fat Emulsion Administration Sets
General Hospital
30d
Cleared
Jun 21, 2017
Solution Set with 1.2 Micron Air Eliminating Filter
General Hospital
355d
Cleared
Jan 06, 2017
PrismaSATE
Gastroenterology & Urology
81d
Cleared
Dec 19, 2016
Paclitaxel Sets
General Hospital
350d
Cleared
Nov 30, 2016
Solution Set for Epidural Use
General Hospital
203d
Cleared
Dec 28, 2015
Solution Administration Sets with 0.2 Micron Filter
General Hospital
56d
Cleared
Oct 29, 2015
FlexiCap Disconnect Cap with Povidone-Iodine Solution, MiniCap with...
Gastroenterology & Urology
90d
Cleared
Apr 16, 2015
Nitroglycerin Sets with DUO-VENT Spike
General Hospital
15d
Cleared
Nov 19, 2014
VIAL-MATE Adaptor
General Hospital
65d
Cleared
Aug 18, 2014
SOLUTION SET/EXTENSION SET
General Hospital
25d