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Merogel Nasal Dressing/Sinus Stent &Otologic Packing 2pk 4x4cm

Anika Therapeutics, Inc. · Model 651-141 · UDI-DI 08033549790714

EMX
10
510(k) clearances
102
Adverse events (2 deaths)
4
Recalls
53
Facilities

Description

Medtronic MeroGel Nasal Dressing/Sinus stent and Otologic Packing is used in the nasal/sinus and the middle ear/external ear canal as a space occupying dressing and/or stent, to separate mucosal surfaces and to help control minimal bleeding following surgery, and in otologic packing, to act as an adjunct to aid in the natural healing process.

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

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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.