Home › Device types › MUI
Media, Coupling, Ultrasound
FDA product code MUI · Class 2 · Radiology
271
Registered devices
70
Adverse events
6
Recalls
34
510(k) clearances
Devices with this code
WINNER EVO PACKAGE — COMPASS HEALTH BRANDS CORP.McKesson — MCKESSON MEDICAL-SURGICAL INC.SheathesGel — SHEATHING TECHNOLOGIES, INC.Medichoice — OWENS & MINOR DISTRIBUTION, INC.CARDINAL HEALTH — Cardinal Health 200, LLCWavelength — National Therapy Products IncWINNER EVO PACKAGE — COMPASS HEALTH BRANDS CORP.HR Ultrasound Jelly — HR PHARMACEUTICALS INC.GelShot — COMPASS HEALTH BRANDS CORP.Dynatron® Lotion, 1 Gallon — Dynatronics CorporationWavelength — National Therapy Products IncCARDINAL HEALTH — Cardinal Health 200, LLCWINNER EVO PACKAGE — COMPASS HEALTH BRANDS CORP.Pharmaceutical Innovations — PHARMACEUTICAL INNOVATIONS INCGelShot — COMPASS HEALTH BRANDS CORP.Pharmaceutical Innovations — PHARMACEUTICAL INNOVATIONS INCGelShot — COMPASS HEALTH BRANDS CORP.SCAN — PARKER LABORATORIES INCSME — SME, INC. USAEcoVue — HR PHARMACEUTICALS INC.Pharmaceutical Innovations — PHARMACEUTICAL INNOVATIONS INCPharmaceutical Innovations — PHARMACEUTICAL INNOVATIONS INCTHERASOUND EVO PACKAGE — COMPASS HEALTH BRANDS CORP.E-Z-GEL UltraSound Gel — Bracco Diagnostics Inc.
Recent recalls
| Date | Firm | Reason |
|---|---|---|
| 2023-07-07 | Advance Medical Designs, Inc. | Ultrasound gel mislabeled with inappropriate use. |
| 2023-07-07 | Advance Medical Designs, Inc. | Ultrasound gel mislabeled with inappropriate use. |
| 2023-06-09 | Turkuaz Saglik Hizmetleri Medikal Temizlik Kim. Ur. San. ve Tic. A.S. | Sterility of Ultrasound gel can not be guaranteed. |
| 2020-08-13 | Pharmaceutical 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. |
| 2012-03-02 | Pharmaceutical 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 |
| 2012-03-02 | Pharmaceutical 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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