Medical Device Manufacturer · US , Mchenry , IL

Baxter Healthcare Corp

505 submissions · 496 cleared · Since 1977
505
Total
496
Cleared
0
Denied

Baxter Healthcare Corp — FDA 510(k) Submissions

Baxter Healthcare Corp has submitted 505 FDA 510(k) premarket notifications since 1977, of which 496 received clearance as substantially equivalent to a predicate device.

The company's most frequent device categories include Set, Administration, Intravascular, Pump, Infusion, Dialyzer, High Permeability With Or Without Sealed Dialysate System, Set, Administration, For Peritoneal Dialysis, Disposable, Multi-analyte Controls, All Kinds (assayed) . Use the specialty filter in the sidebar to narrow results.

505 devices
1–25 of 505
PrisMax System Version 2
K190910 · KDI Dialyzer, High... · Gastroenterology & Urology
Jul 2019 108d
PrisMax Control Unit
K163530 · KDI Dialyzer, High... · Gastroenterology & Urology
May 2017 138d
ULTRAFUSE
K130531 · MQV Filler, Bone Void,... · Orthopedic
Apr 2014 403d
NEUTRAL LUER ACTIVATED DEVICE (ONE-LINK NEEDLE-FREE IV CONNECTOR) AND EXTENSION SETS
K132734 · FPA Set, Administration,... · General Hospital
Oct 2013 35d
LARGE BORE STOPCOCK WITH ROTATING MALE LUER LOCK/LARGE BORE STOPCOCK WITH EXTENSION SET, GANG LARGE BORE STOPCOCK MANIFO
K130245 · FMG Stopcock, I.v. Set · General Hospital
Mar 2013 29d
INTERLINK SYSTEM BURETROL SOLUTION SETS, INTERLINK SYSTEM BURETROL SOLUTION SETS, CONTINUED, CLEARLINK SYSTEM BURETROL S
K123874 · FPA Set, Administration,... · General Hospital
Jan 2013 24d
INTERLINK SYSTEM LEVER LOCK CANNULA WITH CHECK VALVE, SECONDARY MEDICATION SETS, SOLUTION SETS, CONTINU-FLO SOLUTION SET
K123868 · FPA Set, Administration,... · General Hospital
Jan 2013 22d
FLOWEASE [SUBCUTANEOUS] INFUSION SET
K121092 · FPA Set, Administration,... · General Hospital
Jun 2012 80d
NON-DEHP MICRO-VOLUME EXTENSION SET WITH 0.22 MICRON FILTER
K113227 · FPB Filter, Infusion Line · General Hospital
Dec 2011 37d
ADDITIVE CAP
K111217 · KPE Container, I.v. · General Hospital
Jun 2011 43d
HOMECHOICE/HOMECHOICE PRO AUTOMATED PERSONAL CYCLER PERITONEAL DIALYSIS SYSTEM MODEL 5C4471, 5C8310, 5C4471R AND 5C8310R
K102936 · FKX System, Peritoneal,... · Gastroenterology & Urology
Mar 2011 177d
INTERLINK S / CLEARLINK SYSTEM / V-LINK LAD WITH VITALSHIELD PROTECTIVE COATING NON-DEHP CATHETER EXTENSION SET KITS,
K103551 · FPA Set, Administration,... · General Hospital
Mar 2011 113d
CELSTAT
K103245 · QSY Hemostatic Wound Dressing... · General & Plastic Surgery
Mar 2011 141d
DUAL LUER LOCK CAP, MODEL 2C6250
K101385 · FPA Set, Administration,... · General Hospital
Jun 2010 35d
ACID CONCENTRATE 45X (2.0K, 3.1CA), MODEL 5M8001A, ACID CONCENTRATE 45X (2.0K, 2.5CA), MODEL 5M8002A
K090002 · KPO Dialysate Concentrate For... · Gastroenterology & Urology
Aug 2009 217d
TRICOS A RESORBABLE BONE SUBSTITUTE
K081717 · MQV Filler, Bone Void,... · Orthopedic
Oct 2008 114d
TRICOS A RESORBABLE SUBSTITUTE
K081721 · LYC Bone Grafting Material,... · Dental
Aug 2008 49d
V-LINK ANTIMICROBIAL LUER ACTIVATED DEVICE AND EXTENSION SETS WITH V-LINK ANTIMICROBIAL LUER ACTIVATED DEVICE
K081289 · FPA Set, Administration,... · General Hospital
Aug 2008 89d
CLEARLINK ANTIMICROBIAL LUER ACTIVATED DEVICE (LAD) AND EXTENSION SETS WITH THE CLEARLINK ANTIMICROBIAL LUER ACTIVATED
K072576 · FPA Set, Administration,... · General Hospital
Nov 2007 54d
INFUSOR SV AND LV ELASTOMERIC INFUSION DEVICES
K071222 · MEB Pump, Infusion, Elastomeric · General Hospital
May 2007 23d
COLLEAGUE GUARDIAN CONFIGURATION TOOL; COLLEAGUE DL2 EVENT HISTORY DOWNLOAD SOFTWARE APPLICATION
K070125 · FRN Pump, Infusion · General Hospital
Apr 2007 90d
IPUMP PAIN MANAGEMENT SYSTEM, MODEL 2L3107, 2L3107K
K052973 · FRN Pump, Infusion · General Hospital
Jan 2007 458d
RENALSOFT
K061515 · KPF System, Dialysate... · Gastroenterology & Urology
Sep 2006 102d
INTERLINK SYSTEM-T-CONNECTOR EXTENSION SET, MODEL 2N3326
K060074 · FPA Set, Administration,... · General Hospital
Mar 2006 78d
HOMECHOICE/HOMECHOICE PRO PERSONAL CYCLER PERITONEAL DIALYSIS SYSTEM, MODELS 5C4471 AND 5C8310
K053512 · FKX System, Peritoneal,... · Gastroenterology & Urology
Feb 2006 62d

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