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Embosphere Pro™

BIOSPHERE MEDICAL · Model 00884450299449 · UDI-DI 00884450299449

NOY
4
510(k) clearances
3
Adverse events (1 deaths)
1
Recalls
11
Facilities

Recalls

DateFirmReason
2023-12-21MICROVENTION INC.Due to, during the manufacturing process, the prescribed manufacturing and quality processes were not followed and the product was inadvertently distributed.

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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.