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 MindrayLabelled 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 14, 2026, FDA's public records list Mindray DS USA with 47 device recalls and 3 510(k) clearances. The most recent is a device recall dated Aug 31, 2026: ePM Series Patient Monitor. Patient Monitor Series: ePM 10M/ePM 12M/ePM 12MA/ ePM 15M/eP….
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 31, 2026 | ePM Series Patient Monitor. Patient Monitor Series: ePM 10M/ePM 12M/ePM 12MA/ ePM 15M/ePM 10AClass III · Certain monitor operator's manuals contain descriptions that may be insufficient or may require clarification regarding | Device recalls |
| Aug 31, 2026 | BeneVision N1 and N-Series Patient Monitor. Patient Monitor: N12/N15/N17/N19/N22.Class III · Certain monitor operator's manuals contain descriptions that may be insufficient or may require clarification regarding | Device recalls |
| Aug 31, 2026 | Panorama and Telemetry Monitoring System. Operator's Manuals: TMS-6016/Panorama Telepack-608/TMS60 (TD60).Class III · Certain monitor operator's manuals contain descriptions that may be insufficient or may require clarification regarding | Device recalls |
| Aug 31, 2026 | BeneVision Series Telemetry Monitor. Operator's Manuals: TM70/TM80Class III · Certain monitor operator's manuals contain descriptions that may be insufficient or may require clarification regarding | Device recalls |
| Aug 31, 2026 | cPM Series Patient Monitor. Operator's Manual: cPM 8/cPM 12Class III · Certain monitor operator's manuals contain descriptions that may be insufficient or may require clarification regarding | Device recalls |
| Aug 31, 2026 | BeneView Series. Operator's Manuals: T5 / T8Class III · Certain monitor operator's manuals contain descriptions that may be insufficient or may require clarification regarding | Device recalls |
| Aug 31, 2026 | T1 Patient Monitor. Operator's Manual: T1 Patient MonitorClass III · Certain monitor operator's manuals contain descriptions that may be insufficient or may require clarification regarding | Device recalls |
| Aug 31, 2026 | Passport Series Patient Monitor. Operator's Manuals: 8 / 12 / 12M / 17M / VClass III · Certain monitor operator's manuals contain descriptions that may be insufficient or may require clarification regarding | Device recalls |
| Dec 20, 2013 | V SERIES MONITORING SYSTEM, 12.1 DCU/V12 AND 21.0 DCU/V21K132026 · MHX | 510(k) clearances |
| Feb 11, 2011 | AS3700 ANESTHSIA DELIVERY SYSTEMK102471 · BSZ | 510(k) clearances |
| Sep 10, 2010 | ENDEAVOUR MONITORING SYSTEMK102004 · MHX | 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
