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AirGent-2.0
PERFACTION TECHNOLOGIES LTD · Model AA · UDI-DI 07290017151007
1
510(k) clearances
467
Adverse events (2 deaths)
1
Recalls
11
Facilities
Description
The AirGent-2.0 system is a pneumatically powered system that features a safe, minimally-invasive platform for uniformed administration of therapeutic compound into the dermis. The Enerjet2.0 is a needle-free injection system that generates a high velocity jet of fluid that penetrates the skin.
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2010-06-01 | CaridianBCT, Inc. | Labeling clarification and software updates to include fixes for end of run summaries, increasing boot reliability, corrections to the double red blood cell count collection TBV li |
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Get your free API keyRead the docsData compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.