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Media, Coupling, Ultrasound

FDA product code MUI · Class 2 · Radiology

273
Registered devices
70
Adverse events
6
Recalls
34
510(k) clearances

Devices with this code

THERASOUND EVO PACKAGE — Drive Devilbiss HealthcareMedline — MEDLINE INDUSTRIES, INC.Medichoice — OWENS & MINOR DISTRIBUTION, INC.Pharmaceutical Innovations — PHARMACEUTICAL INNOVATIONS INCEcoVue — HR PHARMACEUTICALS INC.AQUASONIC 100 — PARKER LABORATORIES INCWavelength — National Therapy Products IncPharmaceutical Innovations — PHARMACEUTICAL INNOVATIONS INCE-Z-GEL UltraSound Gel — Bracco Diagnostics Inc.Wavelength — National Therapy Products IncSME — SME, INC. USAPharmaceutical Innovations — PHARMACEUTICAL INNOVATIONS INCGelShot — Drive Devilbiss HealthcareEcoVue — HR PHARMACEUTICALS INC.Ultrasound Gel — Dynarex CorporationWavelength — National Therapy Products IncGelShot — Drive Devilbiss HealthcareGelShot — Drive Devilbiss HealthcarePharmaceutical Innovations — PHARMACEUTICAL INNOVATIONS INCAQUASONIC CLEAR — PARKER LABORATORIES INCGelShot — Drive Devilbiss HealthcareMedline — MEDLINE INDUSTRIES, INC.WINNER EVO PACKAGE — Drive Devilbiss HealthcareEcoVue HV — HR PHARMACEUTICALS INC.

Recent recalls

DateFirmReason
2023-07-07Advance Medical Designs, Inc.Ultrasound gel mislabeled with inappropriate use.
2023-07-07Advance Medical Designs, Inc.Ultrasound gel mislabeled with inappropriate use.
2023-06-09Turkuaz Saglik Hizmetleri Medikal Temizlik Kim. Ur. San. ve Tic. A.S.Sterility of Ultrasound gel can not be guaranteed.
2020-08-13Pharmaceutical Innovations, Inc.The firm registered the product as a Class I device, but has since been informed by FDA that the device is not Class I and requires a 510(k) submission.
2012-03-02Pharmaceutical Innovations, Inc.Other-Sonic GENERIC ULTRASOUND TRANSMISSION GEL is being recalled due to possible microbial contamination. An FDA Safety Communication was issued for this produ
2012-03-02Pharmaceutical Innovations, Inc.Other-Sonic GENERIC ULTRASOUND TRANSMISSION GEL is being recalled due to possible microbial contamination. An FDA Safety Communication was issued for this produ

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Sourced from public U.S. FDA data. Informational only — not medical or regulatory advice. Not affiliated with the FDA.