TEVADAPTOR Closed Drug Reconstitution and Transfer System— 510(k) K170680
Substantially EquivalentTeva Medical Ltd., Migada Plant
FDA 510(k) clearance K170680 for TEVADAPTOR Closed Drug Reconstitution and Transfer System, Substantially Equivalent on 2017-05-16. Applicant: Teva Medical Ltd., Migada Plant. Device class: 2.
Clearance details
- Applicant
- Teva Medical Ltd., Migada Plant
- Product code
- Code ONB
- Device class
- Class 2
- Regulation
- 21 CFR 880.5440
- Advisory panel
- General Hospital
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Location
- Kiryat Shmona, IL
Recent devices under product code ONB
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More clearances from Teva Medical Ltd., Migada Plant
view allAdverse events under product code ONB
product code ONB- Malfunction
- 3,615
- Other
- 13
- Total
- 3,628
Source: openFDA MAUDE database, through . 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.