Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Teva Medical Ltd., Migada Plant · Predicate Candidate Screening
4 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K180489 | TEVADAPTOR Closed Drug Reconstitution and Transfer System | Teva Medical Ltd., Migada Plant | 2018-09-21 | 210 | 0 |
| K170680 | TEVADAPTOR Closed Drug Reconstitution and Transfer System | Teva Medical Ltd., Migada Plant | 2017-05-16 | 71 | 0 |
| K141448 | TEVADAPTOR CLOSED DRUG RECONSTITUTION AND TRANSFER SYSTEM | Teva Medical Ltd., Migada Plant | 2015-01-23 | 235 | 0 |
| K141306 | TEVADAPTOR; CONNECTING SET W/ ULTRASITE INJECTION SITE, SPIK | Teva Medical Ltd., Migada Plant | 2014-06-12 | 24 | 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