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 SendX Medical with 6 510(k) clearances and 2 device recalls. The most recent is a 510(k) clearance dated Dec 7, 2015: ABL80 FLEX and ABL80 FLEX CO-OX.
| Dec 7, 2015 | ABL80 FLEX and ABL80 FLEX CO-OXK151639 · CGA | 510(k) clearances |
| Aug 6, 2015 | ABL80 FLEX CO-OX with AQURE connectivityK151856 · CHL | 510(k) clearances |
| Jun 6, 2012 | ABL80 FLEX (with FLEX software) and ABL80 FLEX CO-OX (with CO-OX software) - pH Blood Gas and Electrolytes Analyzer System. Intended Use Class II · The firm recalled because the glucose measurements from a patient sample that the customer felt was too low and did not | Device recalls |
| Jan 6, 2010 | ABL80 FLEX CO-OX analyzer, model #393-841 (all software versions prior to 1.35). The ABL80 FLEX CO-OX is a portable, automated analyzer tClass II · The recall was initiated because SenDx Medical Inc. became aware of a software issue in the ABL80 FLEX CO-OX analyzer re | Device recalls |
| Jul 31, 2008 | ABL 80 CO-OX SYSTEMK080370 · CHL | 510(k) clearances |
| Nov 1, 2005 | ABL80 FLEX ANALYZERK051804 · CHL | 510(k) clearances |
| Feb 1, 2000 | ABL 77 PH, BLOOD GAS AND ELECTROLYTE ANALYSIS SYSTEMK994346 · CHL | 510(k) clearances |
| Dec 3, 1997 | SENDX 100 PH, BLOOD GAS AND ELECTROLYTE ANALYSIS SYSTEMK973742 · CGZ | 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
