FDA Device Intelligence
Home › HEMOSTASIS, LLC › PosiSep X 0.6 x 2.0 Hemostatic Dressing/Intranasal Splint

PosiSep X 0.6 x 2.0 Hemostatic Dressing/Intranasal Splint

HEMOSTASIS, LLC · Model 9210584 · UDI-DI 00858439001330

EMXLYAFRO Prescription
2
510(k) clearances
103
Adverse events (2 deaths)
4
Recalls
51
Facilities

Description

PosiSep X devices are patient-comfortable sponges manufactured from naturally occurring Chitosan polymers. PosiSep X devices expand when hydrated providing separation between the sinus tissues.

Recalls

DateFirmReason
2003-01-08Ultracell Medical TechnologiesSterility of the device is compromised
2003-01-08Ultracell Medical TechnologiesSterility of the device is compromised
2003-01-08Ultracell Medical TechnologiesSterility of the device is compromised
2003-01-08Ultracell Medical TechnologiesSterility of the device is compromised

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 docs
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.