E-Z-EM PULSED INFUSION SYSTEM— 510(k) K905447
Substantially EquivalentE-Z-Em, Inc.
FDA 510(k) clearance K905447 for E-Z-EM PULSED INFUSION SYSTEM, Substantially Equivalent on 1991-04-01. Applicant: E-Z-Em, Inc..
Clearance details
- Applicant
- E-Z-Em, Inc.
- Product code
- Code KRA
- Advisory panel
- Cardiovascular
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Worcester, MA, US
Adverse events under product code KRA
product code KRA- Death
- 234
- Injury
- 1,029
- Malfunction
- 3,012
- Other
- 2
- Total
- 4,277
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.