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.. FDA records under 2 spellings of its name, each linked to the record.
As of Nov 15, 2026, FDA's public records list Intel-GE Care Innovations with 4 device recalls and 3 510(k) clearances. The most recent is a device recall dated Dec 6, 2017: Health Harmony Mobile application software Product Usage: Care Innovations Health H….
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.
| Dec 6, 2017 | Health Harmony Mobile application software Product Usage: Care Innovations Health Harmony Mobile is intended as a communication tool toClass II · It was discovered that in certain situations, including partial sessions and when taking adhoc measurements, the patient | Device recalls |
| Oct 8, 2013 | INTEL-GE CARE INNOVATIONS QUIETCAREK131585 · KMI | 510(k) clearances |
| Aug 9, 2013 | INTEL-GE CARE INNOVATIONS CONNECT RCMK130821 · DRG | 510(k) clearances |
| Jun 4, 2013 | MODIFICATION TO INTEL-GE CARE IINOVATIONS GUIDEK130290 · DRG | 510(k) clearances |
| Apr 4, 2013 | QuietCare. Intended for use in monitoring the environmental conditions and activity (motion) of an individual living in a senior housing Class II · Customers at 4 facilities reported receiving duplicate alerts using the QuietCare-Networked product. | Device recalls |
| Apr 4, 2013 | QuietCare-Networked. Intended for use in monitoring the environmental conditions and activity (motion) of an individual living in a senioClass II · Customers at 4 facilities reported receiving duplicate alerts using the QuietCare-Networked product. | Device recalls |
| Dec 16, 2012 | QuietCare-Networked product, Facility Server/model: QC101601; The QuietCare system is intended to detect and analyze residents' movemenClass II · Care Innovations detected a software anomaly: During the engineering investigation into the cause of why a Wander Alert | Device recalls |
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
