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 Koninklijke PhilipsLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field.. FDA records under 2 spellings of its name, each linked to the record.
As of Nov 15, 2026, FDA's public records list Visicu with 7 510(k) clearances and 1 device recall. The most recent is a 510(k) clearance dated Jun 3, 2022: eCareManager 4.5.
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.
| Jun 3, 2022 | eCareManager 4.5K211046 · MSX | 510(k) clearances |
| Aug 3, 2017 | eCareManager 4.1K171322 · MSX | 510(k) clearances |
| Jul 14, 2017 | eCareCoordinatorK171029 · DRG | 510(k) clearances |
| Sep 30, 2016 | eCareManager 4.0.1K153156 · MSX | 510(k) clearances |
| Mar 27, 2015 | The eCareManager system. Software intended for use in data collection, storage and clinical information management with independent bedsideClass II · A software defect may cause incorrect medication order change. If the user decides to edit the order prior to electroni | Device recalls |
| Sep 9, 2014 | ECARE COORDINATOR (ECC)K141706 · DRG | 510(k) clearances |
| Jul 24, 2001 | MODIFICATION TO: ARGUS SYSTEM-CONTINUOUS EXPERT CARE NETWORK W/SMART ALRAMSK012171 · MSX | 510(k) clearances |
| Oct 27, 2000 | ARGUS SYSTEM-CONTINUOUS EXPERT CARE NETWORKK001972 · MSX | 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
