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Treatment Kit 2.0

VIORA LTD · Model GM00030 (US) · UDI-DI 07290016746754

KZE Prescription
10
510(k) clearances
467
Adverse events (2 deaths)
1
Recalls
11
Facilities

Description

EnerJet Treatment Kit

Recalls

DateFirmReason
2010-06-01CaridianBCT, 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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Linked GUDID · 510(k)/PMA · MAUDE · recalls · establishments. Free tier, no card required.

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Data 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.