Medical device makerLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field.. FDA records under its name, each linked to the record.
As of Nov 13, 2026, FDA's public records list R2 with 9 510(k) clearances. The most recent is a 510(k) clearance dated Dec 16, 1983: MAGNATRODE CARDIAC MONITORING ELECTRODE.
| Date | Record | Source |
|---|---|---|
| Dec 16, 1983 | MAGNATRODE CARDIAC MONITORING ELECTRODEK832516 · DRX | 510(k) clearances |
| May 23, 1980 | ECG-RF-CHOKE CABLE-ADAPTER #'S 121,120K800932 · DSA | 510(k) clearances |
| May 23, 1980 | R2 PLATE TYPE CABLE-ADAPTOR #S 175,176K800937 · LDD | 510(k) clearances |
| May 23, 1980 | R2 PADDLE TYPE CABLE-ADAPTOR #S 170,171K800936 · LDD | 510(k) clearances |
| May 23, 1980 | R2 APEX-POST.,ANT.&POST. ELECT.(12 MODS)K800935 · DRX | 510(k) clearances |
| May 23, 1980 | R2(TM) ECG CABLE-ADAPTOR #'S 120-121-122K800931 · DSA | 510(k) clearances |
| May 23, 1980 | R2(TM) ECG ELECTRODE SET-#'S305-306 ETC.K800930 · DRX | 510(k) clearances |
| May 20, 1980 | R2 ESU CABLE-ADAPTER MODELS 160,161K800934 · IKD | 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
