MEDRAD CONTINUUM MR INFUSION SYSTEM WITH WIRELESS REMOTE ACCESSORY— 510(k) K073051

Substantially Equivalent

Medrad, Inc.

FDA 510(k) clearance K073051 for MEDRAD CONTINUUM MR INFUSION SYSTEM WITH WIRELESS REMOTE ACCESSORY, Substantially Equivalent on 2008-05-30. Applicant: Medrad, Inc..

Clearance details

Applicant: Medrad, Inc.
Product code: Code FRN
Advisory panel: General Hospital
Date received: 2007-10-29
Decision date: 2008-05-30
Decision: Substantially Equivalent
Clearance type: Abbreviated
Location: Indianola, PA, US

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Adverse events under product code FRN

product code FRN

Death: 540
Injury: 6,178
Malfunction: 1,464,165
Other: 52
Total: 1,470,935

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.