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ViVi Helmet HPL
THI Total Healthcare Innovation GmbH · Model 80130 · UDI-DI 09009607801301
FXY
Prescription
10
510(k) clearances
51
Adverse events
3
Recalls
24
Facilities
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2024-02-20 | O&M HALYARD, INC. | Product was mislabeled as a Surgical Cap at its dispenser level. |
| 2005-09-13 | VIASYS Med Systems | The packaging may be compromised such that sterility of the hoods cannot be guaranteed. |
| 2005-09-13 | VIASYS Med Systems | The packaging may be compromised such that sterility of the hoods cannot be guaranteed. |
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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.