FDA 510(k) Applications for Medical Device Product Code "MUI"
(Media,Coupling,Ultrasound)
| FDA 510(k) Number | Applicant | Device Name | Decision Date |
| K163050 | ADVANCE MEDICAL DESIGNS, INC. | Advance Medical Designs, Inc. Sterile Ultrasound Gel | 10/25/2017 |
| K131905 | BLUEMTECH | SOLID GEL PAD | 07/18/2013 |
| K121311 | CLOVERLINE INTERNATIONAL PHARMA SERVICES GMBH | THIXO-GEL ULTRASOUND SPRAY | 08/30/2012 |
| K102637 | DYNAREX CORPORATION | DYNAREX ULTRASOUND GEL | 02/16/2011 |
| K083358 | FARCO PHARMA GMBH | LUBRICANO-ULTRASOUND | 01/09/2009 |
| K221999 | Hony Medical Co., Ltd. | Ultrasound Transmission Gels | 08/30/2022 |
| K181363 | HR Pharmaceuticals, Inc. | EcoVue Sterile and Non-Sterile Ultrasound Gels | 06/13/2018 |
| K030889 | INMED LTDA. | ULTRAEKOGEL MODELS EK 2000 & EK 2001 | 05/23/2003 |
| K020956 | MICROTEK MEDICAL, INC. | VIVOSONIC DIANOSTIC ULTRASOUND IMAGING COUPLING MEDIA | 05/16/2002 |
| K013212 | NATIONAL THERAPY PRODUCTS INC. | WAVELENGHT ULTRASOUND LOTION | 02/25/2002 |
| K102683 | OB THE-ADDITION, LLC | THE ADDITION | 01/06/2011 |
| K072515 | ORISON CORPORATION | EMBRACE GEL | 09/20/2007 |
| K163026 | Pharmaceutical Innovations Inc. | Ultra/Phonic Scanning Gel | 01/09/2018 |
| K163023 | PHARMACEUTICAL INNOVATIONS, INC. | Other-Sonic Transmission Gel | 01/08/2018 |
| K163024 | PHARMACEUTICAL INNOVATIONS, INC. | Ultra/Phonic Conductivity Gel | 01/08/2018 |
| K163027 | PHARMACEUTICAL INNOVATIONS, INC. | Ultra/Phonic Free Conductivity Gel | 01/09/2018 |
| K151070 | Quotient Medical | Sonishield 100 Antimicrobial Ultrasound Gel | 01/13/2016 |
| K031018 | RICH-MAR CORP. | AUTOGEL PAD | 12/08/2003 |
| K190591 | Safersonic US, Inc. | Safergel Sterile Ultrasound Gel | 10/04/2019 |
| K130041 | SHEATHING TECHNOLOGIES, INC. | SHEATHES STERILE ULTRASOUND GEL | 02/06/2013 |
| K112827 | SHEATHING TECHNOLOGIES, INC. | SHEATHES ULTRASOND GEL | 06/22/2012 |
| K031222 | SONOTECH, INC. | SCANLUBE | 07/23/2003 |
| K031894 | SONOTECH, INC. | SCANTEC PAD | 07/18/2003 |
| K033178 | SONOTECH, INC. | ULTRABIO | 08/04/2004 |
| K042619 | SONOTECH, INC. | ULTRABIO - IN VIVO BIOCOMPATIBLE, BIOELIMINATED STERILE ULTRASOUND IMAGING COUPLANT | 11/05/2004 |
| K021132 | THE LUDLOW COMPANY LP | UNI-PATCH ULTRASOUND COUPLING GEL | 05/15/2002 |
| K130581 | TURKUAZ SAGLIK HIZMETLERI MEDIKAL TEMIZLIK KIMYASA | KONIX STERILE GEL | 06/18/2014 |
| K211691 | Ultrast, Inc. | Ultrast Gel | 12/22/2021 |
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