TEVADAPTOR Closed Drug Reconstitution and Transfer System— 510(k) K180489

Substantially Equivalent

Teva Medical Ltd., Migada Plant

FDA 510(k) clearance K180489 for TEVADAPTOR Closed Drug Reconstitution and Transfer System, Substantially Equivalent on 2018-09-21. Applicant: Teva Medical Ltd., Migada Plant.

Clearance details

Applicant: Teva Medical Ltd., Migada Plant
Product code: Code ONB
Advisory panel: General Hospital
Date received: 2018-02-23
Decision date: 2018-09-21
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Kiryat Shmona, IL

Download summary PDF View on FDA.gov ↗

Adverse events under product code ONB

product code ONB

Malfunction: 3,615
Other: 13
Total: 3,628

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.