PORTEX NEEDLE-PRO EDGE SAFETY WITH SYRINGE, MODELS 432310, 432210, 432510, 432558— 510(k) K061194
Substantially EquivalentSmiths Medical Asd, Inc.
FDA 510(k) clearance K061194 for PORTEX NEEDLE-PRO EDGE SAFETY WITH SYRINGE, MODELS 432310, 432210, 432510, 432558, Substantially Equivalent on 2006-08-24. Applicant: Smiths Medical Asd, Inc.. Device class: 2.
Clearance details
- Applicant
- Smiths Medical Asd, Inc.
- Product code
- Code MEG
- Device class
- Class 2
- Regulation
- 21 CFR 880.5860
- Advisory panel
- General Hospital
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Abbreviated
- Location
- Keene, NH, US
Recent devices under product code MEG
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Adverse events under product code MEG
product code MEG- Malfunction
- 1,373
- Other
- 1
- Total
- 1,374
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.