Disposable Syringe with permanently attached needle, Safety Syringe with permanently attached needle— 510(k) K221308
Substantially EquivalentJiangxi Maidikang Medical Devices Co., Ltd.
FDA 510(k) clearance K221308 for Disposable Syringe with permanently attached needle, Safety Syringe with permanently attached needle, Substantially Equivalent on 2022-10-17. Applicant: Jiangxi Maidikang Medical Devices Co., Ltd..
Clearance details
- Applicant
- Jiangxi Maidikang Medical Devices Co., Ltd.
- Product code
- Code FMF
- Advisory panel
- General Hospital
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Yichun, CN
Adverse events under product code FMF
product code FMF- Death
- 15
- Injury
- 2,263
- Malfunction
- 29,722
- Other
- 17
- Total
- 32,017
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.