Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Electronic Business Machine Co., Ltd. (Ebm) · Predicate Candidate Screening
3 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K071166 | UNIWEB, VERSION 5.0 | Electronic Business Machine Co., Ltd. (Ebm) | 2007-07-23 | 88 | 0 |
| K062743 | UNISIGHT MAMMOGRAPHY VIEWER, MODEL 4.0 | Electronic Business Machine Co., Ltd. (Ebm) | 2006-10-31 | 47 | 0 |
| K023394 | UNISIGHT SYSTEM WITH UNIGATE | Electronic Business Machine Co., Ltd. (Ebm) | 2003-01-07 | 90 | 0 |
Methodology
Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.
Prepared with Atlas
Predicate research, review-time statistics and recall monitoring for 510(k) teams: atlasbyauro.com/fda