K945567
Substantially EquivalentQC CAP
- Applicant
- Medionics International, Inc.
- Product code
- KDJ
- Advisory panel
- Gastroenterology, Urology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Markham, Ontario, CA
Adverse events under product code KDJ
product code KDJ- Death
- 298
- Injury
- 9,221
- Malfunction
- 8,438
- Other
- 1
- Total
- 17,958
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.