Company
Baxter Corporation Englewood
FDA 510(k) clearances and medical device recalls filed under this name. Name variants (Inc, Corp, punctuation) are merged.
0510(k) clearances (0 in 12 months)
9recalls (0 in 12 months)
2recalls that name a 510(k)
Product codes
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| No clearances in this window. | |||
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Oct 6, 2016 | Baxter Corporation Englewood 0.2 Micron Filter, 50 mm
Product Usage:
The 0.2 Micron Filter is a bacteria and particulate filter for aqueous solutions. It attaches to a standard Baxter Pharmacy Pump Tube Set. Terminated |
LHI | K900585 |
| Jan 30, 2016 | Baxter Corporation Englewood Baxter, RAPIDFILL Syringe Strip, 10 ml.
For use with RAPIDFILL Automated Syringe Filler (ASF) Terminated |
FMF | K980181 |
| May 18, 2015 | Baxter Corporation Englewood ABACUS SE (Single-Workstation Edition) and ABACUS ME (Multi-Workstation Edition)
Product Usage:
The ABACUS Software is a Windows-based order entry software application for comprehensive total parente Terminated |
NEP | None listed |
| Feb 27, 2015 | Baxter Corporation Englewood Baxter, Self-Righting Syringe Tip Caps, Self-Righting DISCPAC Syringe Tip Caps. Product codes H93866100, H93869100, H93866025, H93867025, H93867100, H938671025, H938671100, H938673025, H938673100, Terminated |
KYX | None listed |
| Dec 24, 2014 | Baxter Corporation Englewood Self-Righting Luer Lock Tip Cap, Green and Self-Righting Luer Slip Tip Cap, Yellow, Baxter Healthcare Corporation, 14445 Grasslands Dr. Englewood, CO 80112 USA. DISCPAC Syringe Tip Caps. RER H93866100 Terminated |
KYX | None listed |
| Jun 22, 2014 | Baxter Corporation Englewood Abacus 3.1, Pharmacy Calculator
Product Usage:
Provide pharmacy calculations for automated compounding. Terminated |
NEP | None listed |
| May 14, 2014 | Baxter Corporation Englewood RAPIDFILL Syringe Strip, For use with RAPIDFILL Automated Syringe Filler (ASF): H93890200 RAPIDFILL Syringe Strip, White. H93890221 RAPIDFILL Syringe Strip, Yellow. H93890222 RAPIDFILL Syringe Strip, Terminated |
FMF | None listed |
| May 12, 2014 | Baxter Corporation Englewood ABACUS TPN Calculation Software, Product Codes: 8300-0045 ABACUS CE (Calculator Edition), 8300-0046 ABACUS SE (Single-Workstation Edition), 8300-0047 ABACUS ME (Multi-Workstation Edition), 8300-0156 A Terminated |
NEP | None listed |
| Dec 18, 2013 | Baxter Corporation Englewood ABACUS TPN Calculation Software, Baxa: 8300-0045 ABACUS CE (Calculator Edition), 8300-0046 ABACUS SE (Single-Workstation Edition), 8300-0047 ABACUS ME (Multi-Workstation Edition)
ABACUS is a Windows Terminated |
LNX | None listed |