Medical device makerLabelled 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 Zoe Medical with 5 510(k) clearances and 3 device recalls. The most recent is a device recall dated Aug 13, 2024: Spacelabs Ultraview DM3 Vital Signs Monitor (all variations -M, -MT, -N, -NT), Model Num….
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.
| Aug 13, 2024 | Spacelabs Ultraview DM3 Vital Signs Monitor (all variations -M, -MT, -N, -NT), Model Number 91330Class II · This product labeling does not adequately provide warning about the risks associated with the use of damaged batteries o | Device recalls |
| Aug 13, 2024 | Spacelabs Ultraview DM4 Vital Signs Monitor (all variations -M, -N, -MF, -NF, -MW, -NW, -MFW, -NFW), Model Number 91331Class II · This product labeling does not adequately provide warning about the risks associated with the use of damaged batteries o | Device recalls |
| Feb 15, 2021 | 740 SafeSATK200160 · MWI | 510(k) clearances |
| Jul 23, 2013 | NIGHTINGALE MONITORING SYSTEMK130740 · MWI | 510(k) clearances |
| Jun 6, 2012 | Spacelabs Ultraview DM3 Monitor Model Number: 91330-NT The Ultraview DM3 Monitor is indicated for use by health care professionals for mClass II · Unit fails to power up, resulting in an equipment alarm | Device recalls |
| Apr 9, 2010 | ULTRAVIEW DM3 MONITORK093802 · DXN | 510(k) clearances |
| Apr 2, 2004 | WELL@HOME SYSTEMK040012 · DXN | 510(k) clearances |
| Jan 12, 2001 | ZOE MEDICAL NIGHTINGALE MONITORING SYSTEMK001775 · DRT | 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
