Medical device makerLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field. in United StatesLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field., part of Becton DickinsonLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field.. FDA records under 3 spellings of its name, each linked to the record.
As of Nov 15, 2026, FDA's public records list CareFusion 303 with 173 device recalls and 7 510(k) clearances. The most recent is a 510(k) clearance dated Apr 25, 2025: BD Alaris Infusion System with Guardrails Suite MX.
Drug approvals, 510(k) clearances, recalls and letters, 2017 to 2026 to date
A hatched bar is a year that is not over, so its count covers only part of the year.
| Apr 25, 2025 | BD Alaris Infusion System with Guardrails Suite MXK243855 · FRN | 510(k) clearances |
| Jul 21, 2023 | BD Alaris System with Guardrails Suite MX v12.1.2K211218 · FRN | 510(k) clearances |
| Jul 19, 2017 | MaxZero Extension Sets with Needless ConnectorK171957 · FPA | 510(k) clearances |
| Jun 22, 2017 | Multi-Link X2 ECG Adapter and Direct Connect Lead Wire SystemK163316 · DSA | 510(k) clearances |
| Aug 21, 2014 | ALARIS SYSTEM WITH GUARDRAILS SUITE MXK133532 · FRN | 510(k) clearances |
| Dec 20, 2012 | CareFusion SmartSite Gravity Blood Set Model 42082E. Used to administer blood and blood products through a needle or catheter inserted intClass II · CareFusion is recalling the SmartSite¿ Gravity Blood Set as a result of a potential for separation at the connection of | Device recalls |
| Mar 26, 2012 | ALARIS PC UNIT MODULE 8000 WITH SOFTWARE CORRECTIONK110535 · FRN | 510(k) clearances |
| Jul 5, 2011 | WIRELESS MONITORING SYSTEMK110809 · DRG | 510(k) clearances |
Spellings are joined only when they reduce to the same name, or a reviewed source names the same company. Sharing an FDA establishment number (FEI) is not enough: contract sites make products for many firms. Facts marked AI were labelled by a language model from the firm's FDA names; everything else comes from FDA or Wikidata. How this page is built
