MICROSTREAM FILLERLINE OR/EMS— 510(k) K980324
Substantially EquivalentOridion Medical , Ltd.
FDA 510(k) clearance K980324 for MICROSTREAM FILLERLINE OR/EMS, Substantially Equivalent on 1998-04-16. Applicant: Oridion Medical , Ltd.. Device class: 2.
Clearance details
- Applicant
- Oridion Medical , Ltd.
- Product code
- Code CCK
- Device class
- Class 2
- Regulation
- 21 CFR 868.1400
- Advisory panel
- Anesthesiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Jerusalem, IL
Recent devices under product code CCK
view allMore clearances from Oridion Medical , Ltd.
view allAdverse events under product code CCK
product code CCK- Death
- 3
- Malfunction
- 11,428
- Total
- 11,431
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 →
Recalls naming K980324
K-number listed on FDA's recall recordMatched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K980324.
Data sourced from openFDA. This site is unofficial and independent of the FDA.