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Soft-Form™ Thermo Plastic External Nasal Splints

INVOTEC INTERNATIONAL, INC. · Model 20-10111 · UDI-DI 00818501022595

EPP
10
510(k) clearances
19
Adverse events
2
Recalls
38
Facilities

Description

Soft-Form™ Thermo Plastic External Nasal Splints, Regular

Recalls

DateFirmReason
2011-02-21Medtronic Xomed, Inc.Medtronic Xomed, Inc. Jacksonville, FL issued a recall on Feb 21, 2011 for all lots of the alcohol pad packaged with the Medtronic's External Nasal Splints REF 1528116 (sm), 152812
2011-02-21Medtronic Xomed, Inc.Medtronic Xomed, Inc. Jacksonville, FL issued a recall on Feb 21, 2011 for all lots of the alcohol pad packaged with the Medtronic's External Nasal Splints REF 1528116 (sm), 152812

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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.