Home › Micro Therapeutics, Inc. › Onyx 34
Onyx 34
Micro Therapeutics, Inc. · Model 105-7100-080 · UDI-DI 00836462005051
MFE
Prescription
0
510(k) clearances
3,134
Adverse events (267 deaths)
2
Recalls
3
Facilities
Description
Liquid Embolic 105-7100-080 Onyx 34
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2024-01-11 | Micro Therapeutics, Inc. | European version of microcatheter were distributed within US which contain a different "Indications for Use". |
| 2024-01-11 | Micro Therapeutics, Inc. | European version of microcatheter were distributed within US which contain a different "Indications for Use". |
Query this across every FDA database — by API.
Linked GUDID · 510(k)/PMA · MAUDE · recalls · establishments. Free tier, no card required.
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.