Media, Coupling, Ultrasound
Regulation 892.1570
2510(k)s in 12 months (34 all time)
0recalls in 12 months (6 all time)
3recalls that name a 510(k)
Top companies in MUI
| Company | 510(k)s | Recalls |
|---|---|---|
| Pharmaceutical Innovations, Inc. | 4 | 3 |
| Sonotech, Inc. | 4 | 0 |
| Advance Medical Designs, Inc. | 1 | 2 |
| Hony Medical Co., Ltd. | 2 | 0 |
| Sheathing Technologies, Inc. | 2 | 0 |
| Anhui Deepblue Medical Technology Co., Ltd. | 1 | 0 |
| Bluemtech | 1 | 0 |
| Cloverline International Pharma Services GmbH | 1 | 0 |
| Dynarex Corporation | 1 | 0 |
| Edgecare, Inc. | 1 | 0 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Jun 17, 2026 | K253255 | Non-Sterile Ultrasound Gel Sterile Ultrasound Gel Foshan Pingchuang Medical Technology Co., Ltd., CN | MUI |
| Apr 24, 2026 | K252337 | EdgeFlow Gel Pad Edgecare, Inc., KR | MUI |
| Sep 19, 2024 | K242167 | Sterile and Non-Sterile Ultrasonic Coupling Agent Anhui Deepblue Medical Technology Co., Ltd., CN | MUI |
| Jul 24, 2024 | K241789 | Non-Sterile Ultrasound Transmission Gels Hony Medical Co., Ltd., CN | MUI |
| Dec 15, 2023 | K232957 | Sterile and Non-Sterile Ultrasound Gels Jianerkang Medical Co., Ltd., CN | MUI |
| Aug 30, 2022 | K221999 | Ultrasound Transmission Gels Hony Medical Co., Ltd., CN | MUI |
| Dec 22, 2021 | K211691 | Ultrast Gel Ultrast, Inc. | MUI |
| Oct 4, 2019 | K190591 | Safergel Sterile Ultrasound Gel Safersonic Us, Inc. | MUI |
| Jun 13, 2018 | K181363 | EcoVue Sterile and Non-Sterile Ultrasound Gels H R Pharmaceuticals, Inc. | MUI |
| Jan 9, 2018 | K163027 | Ultra/Phonic Free Conductivity Gel Pharmaceutical Innovations, Inc. | MUI |
| Jan 9, 2018 | K163026 | Ultra/Phonic Scanning Gel Pharmaceutical Innovations, Inc. | MUI |
| Jan 8, 2018 | K163024 | Ultra/Phonic Conductivity Gel Pharmaceutical Innovations, Inc. | MUI |
| Jan 8, 2018 | K163023 | Other-Sonic Transmission Gel Pharmaceutical Innovations, Inc. | MUI |
| Oct 25, 2017 | K163050 | Advance Medical Designs, Inc. Sterile Ultrasound Gel Advance Medical Designs, Inc. | MUI |
| Jan 13, 2016 | K151070 | Sonishield 100 Antimicrobial Ultrasound Gel Quotient Medical, CA | MUI |
| Jun 18, 2014 | K130581 | KONIX STERILE GEL Turkuaz Saglik Hizmetleri Medikal Temizlik Kimyasa | MUI |
| Jul 18, 2013 | K131905 | SOLID GEL PAD Bluemtech | MUI |
| Feb 6, 2013 | K130041 | SHEATHES STERILE ULTRASOUND GEL Sheathing Technologies, Inc. | MUI |
| Aug 30, 2012 | K121311 | THIXO-GEL ULTRASOUND SPRAY Cloverline International Pharma Services GmbH | MUI |
| Jun 22, 2012 | K112827 | SHEATHES ULTRASOND GEL Sheathing Technologies, Inc. | MUI |
| Feb 16, 2011 | K102637 | DYNAREX ULTRASOUND GEL Dynarex Corporation | MUI |
| Jan 6, 2011 | K102683 | THE ADDITION Ob The-Addition, LLC | MUI |
| Jan 9, 2009 | K083358 | LUBRICANO-ULTRASOUND Farco Pharma GmbH | MUI |
| Sep 20, 2007 | K072515 | EMBRACE GEL Orison Corporation | MUI |
| Nov 5, 2004 | K042619 | ULTRABIO - IN VIVO BIOCOMPATIBLE, BIOELIMINATED STERILE ULTRASOUND IMAGING COUPLANT Sonotech, Inc. | MUI |
| Aug 4, 2004 | K033178 | ULTRABIO Sonotech, Inc. | MUI |
| Dec 8, 2003 | K031018 | AUTOGEL PAD Rich-Mar Corp. | MUI |
| Jul 23, 2003 | K031222 | SCANLUBE Sonotech, Inc. | MUI |
| Jul 18, 2003 | K031894 | SCANTEC PAD Sonotech, Inc. | MUI |
| May 23, 2003 | K030889 | ULTRAEKOGEL MODELS EK 2000 & EK 2001 Inmed Ltda. | MUI |
| May 16, 2002 | K020956 | VIVOSONIC DIANOSTIC ULTRASOUND IMAGING COUPLING MEDIA Microtek Medical, Inc. | MUI |
| May 15, 2002 | K021132 | UNI-PATCH ULTRASOUND COUPLING GEL The Ludlow Company LP | MUI |
| Feb 25, 2002 | K013212 | WAVELENGHT ULTRASOUND LOTION National Therapy Products, Inc., CA | MUI |
| Apr 16, 1982 | K827296 | POLYSONIC ULTRASOUND LOTION Parker Laboratories, Inc. | MUI |
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