DistributorLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field. in IsraelLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field., part of McKessonLabelled 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 McKesson Israel with 5 510(k) clearances and 2 device recalls. The most recent is a device recall dated Mar 12, 2018: McKesson Cardiology Hemo, Release SW version 13.0. Used for physiological monitoring, i….
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.
| Mar 12, 2018 | McKesson Cardiology Hemo, Release SW version 13.0. Used for physiological monitoring, image and data processing. McKesson Cardiology HeClass II · Change Healthcare has identified an issue where, under certain circumstances, the Real Time Monitor (RTM) may not displa | Device recalls |
| Aug 11, 2015 | McKesson CardiologyK151850 · LLZ | 510(k) clearances |
| Dec 19, 2014 | McKesson Cardiology ECG Management It is a software application designed to import, display, store, analyze, distribute and manage informClass II · An ECG procedure time stamp is incorrect, due to a software error in the McKesson Cardiology ECG Management with softwar | Device recalls |
| Apr 18, 2014 | MCKESSON CARDIOLOGY ECG MOBILEK133534 · DQK | 510(k) clearances |
| Dec 5, 2013 | MCKESSON CARDIOLOGY HEMOK131497 · MWI | 510(k) clearances |
| Mar 16, 2012 | HORIZON CARDIOLOGY ECG MANAGEMENTK113515 · DQK | 510(k) clearances |
| Jan 30, 2012 | MCKESSON HORIZON CARDIOLOGYK112720 · LLZ | 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
