BIO-MED SOFT INSULIN SYRINGE: MODELS 1CC, 0.5CC, 0.3CC— 510(k) K081547
Substantially EquivalentBio-Med USA, Inc.
FDA 510(k) clearance K081547 for BIO-MED SOFT INSULIN SYRINGE: MODELS 1CC, 0.5CC, 0.3CC, Substantially Equivalent on 2008-09-08. Applicant: Bio-Med USA, Inc..
Clearance details
- Applicant
- Bio-Med USA, Inc.
- Product code
- Code FMF
- Advisory panel
- General Hospital
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Paterson, NJ, US
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.