DistributorLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field. in JapanLabelled 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 14, 2026, FDA's public records list Suzuken Co., Ltd. with 13 510(k) clearances. The most recent is a 510(k) clearance dated Jun 1, 2018: Kenz Cardico1211.
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.
| Jun 1, 2018 | Kenz Cardico1211K172068 · DPS | 510(k) clearances |
| Jan 6, 2011 | KENZ CARDY302 MAXK101024 · MWJ | 510(k) clearances |
| Oct 13, 2009 | DISPOSAL ECG ELECTRODES, MODEL EASYRODEK092389 · DRX | 510(k) clearances |
| Jan 8, 2001 | KENZ ECG 108 SINGLE CHANNEL DIGITAL ELECTROCARDIOGRAPHS; KENZ ECG 110 SINGLE CHANNEL DIGITAL ELECTROCARDIOGRAPHS WITH ECK001896 · DPS | 510(k) clearances |
| Jul 1, 1987 | KENZ-CARDICO 1201K870443 · LOS | 510(k) clearances |
| Aug 6, 1986 | KENZ-ECG-102 SINGLE CHANNEL ELECTROCARDIOGRAPHK862544 · DPS | 510(k) clearances |
| Jul 11, 1985 | KENZ 80Z MARK IIK843731 · DSI | 510(k) clearances |
| Dec 15, 1982 | ELECTROCARDIOGRAPH INTERPRETERK822968 · DSI | 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
