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 its name, each linked to the record.
As of Nov 15, 2026, FDA's public records list Nikomed U.S.A., Inc. with 15 510(k) clearances. The most recent is a 510(k) clearance dated Jan 9, 2003: NIKOMED TRACE 1 ECG ELECTRODES.
| Jan 9, 2003 | NIKOMED TRACE 1 ECG ELECTRODESK022909 · DRX | 510(k) clearances |
| Feb 4, 2000 | NIKOPAD ELECTROSURGICAL GROUNDING PAD, MODEL 4777MK000079 · HAM | 510(k) clearances |
| Dec 12, 1995 | DISPOSABLE ECG MONITORING ELECTRODEK950473 · DRX | 510(k) clearances |
| Nov 14, 1995 | DISPOSABLE ECG MONITORING ELECTRODE #4110 45MM, #4140 35MMK950472 · DRX | 510(k) clearances |
| Nov 14, 1995 | DISPOSABLE ECG MONITORING ELECTRODE #4530, #4540K950475 · DRX | 510(k) clearances |
| Nov 6, 1995 | DISPOSABLE ECG MONITORING ELECTRODE #4580 32X45MMK950471 · DRX | 510(k) clearances |
| Nov 6, 1995 | DISPOSABLE ECG MONITORING ELECTRODE #4535 32X45MMK950470 · DRX | 510(k) clearances |
| Nov 6, 1995 | DISPOSABLE ECG MONITORING ELECTRODE #4560 38X60MMK950477 · DRX | 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
