MONOJECT HYPODERMIC NEEDLE, MODEL 250, 30 GAUGE HYPODERMIC NEEDLE— 510(k) K073122
Substantially EquivalentCovidien Lp, Formerly Registered AS Tyco Healthcar
FDA 510(k) clearance K073122 for MONOJECT HYPODERMIC NEEDLE, MODEL 250, 30 GAUGE HYPODERMIC NEEDLE, Substantially Equivalent on 2007-11-21. Applicant: Covidien Lp, Formerly Registered AS Tyco Healthcar.
Clearance details
- Applicant
- Covidien Lp, Formerly Registered AS Tyco Healthcar
- Product code
- Code FMI
- Advisory panel
- General Hospital
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Abbreviated
- Location
- Mansfield, MA, US
Adverse events under product code FMI
product code FMI- Death
- 28
- Injury
- 1,517
- Malfunction
- 23,981
- Other
- 18
- Total
- 25,544
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.