Atlas FDA

MUI

34 FDA 510(k) clearances · Product code

121 daysmedian time to decision
434 days90th percentile
34clearances measured

FDA profile

Official device name
Media, Coupling, Ultrasound
Device class
Class II (moderate risk)
Regulation
21 CFR 892.1570
Medical specialty
Radiology
Flags
Third-party review eligible
Adverse events (MAUDE)
1999: 3 · 2010: 6 · 2021: 13 · 2025: 25
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
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RecordFirmDate
Non-Sterile Ultrasound Gel Sterile Ultrasound Gel (K253255)Foshan Pingchuang Medical Technology Co., Ltd.2026-06-17
EdgeFlow Gel Pad (K252337)Edgecare, Inc.2026-04-24
Sterile and Non-Sterile Ultrasonic Coupling Agent (K242167)Anhui Deepblue Medical Technology Co., Ltd.2024-09-19
Non-Sterile Ultrasound Transmission Gels (K241789)Hony Medical Co., Ltd.2024-07-24
Sterile and Non-Sterile Ultrasound Gels (K232957)Jianerkang Medical Co., Ltd.2023-12-15
Ultrasound Transmission Gels (K221999)Hony Medical Co., Ltd.2022-08-30
Ultrast Gel (K211691)Ultrast, Inc.2021-12-22
Safergel Sterile Ultrasound Gel (K190591)Safersonic Us, Inc.2019-10-04
EcoVue Sterile and Non-Sterile Ultrasound Gels (K181363)H R Pharmaceuticals, Inc.2018-06-13
Ultra/Phonic Scanning Gel (K163026)Pharmaceutical Innovations, Inc.2018-01-09
Ultra/Phonic Free Conductivity Gel (K163027)Pharmaceutical Innovations, Inc.2018-01-09
Other-Sonic Transmission Gel (K163023)Pharmaceutical Innovations, Inc.2018-01-08
Ultra/Phonic Conductivity Gel (K163024)Pharmaceutical Innovations, Inc.2018-01-08
Advance Medical Designs, Inc. Sterile Ultrasound Gel (K163050)Advance Medical Designs, Inc.2017-10-25
Sonishield 100 Antimicrobial Ultrasound Gel (K151070)Quotient Medical2016-01-13
KONIX STERILE GEL (K130581)Turkuaz Saglik Hizmetleri Medikal Temizlik Kimyasa2014-06-18
SOLID GEL PAD (K131905)Bluemtech2013-07-18
SHEATHES STERILE ULTRASOUND GEL (K130041)Sheathing Technologies, Inc.2013-02-06
THIXO-GEL ULTRASOUND SPRAY (K121311)Cloverline International Pharma Services GmbH2012-08-30
SHEATHES ULTRASOND GEL (K112827)Sheathing Technologies, Inc.2012-06-22
DYNAREX ULTRASOUND GEL (K102637)Dynarex Corporation2011-02-16
THE ADDITION (K102683)Ob The-Addition, LLC2011-01-06
LUBRICANO-ULTRASOUND (K083358)Farco Pharma GmbH2009-01-09
EMBRACE GEL (K072515)Orison Corporation2007-09-20
ULTRABIO - IN VIVO BIOCOMPATIBLE, BIOELIMINATED STERILE ULTRASOUND IMAGING COUPLANT (K042619)Sonotech, Inc.2004-11-05
ULTRABIO (K033178)Sonotech, Inc.2004-08-04
AUTOGEL PAD (K031018)Rich-Mar Corp.2003-12-08
SCANLUBE (K031222)Sonotech, Inc.2003-07-23
SCANTEC PAD (K031894)Sonotech, Inc.2003-07-18
ULTRAEKOGEL MODELS EK 2000 & EK 2001 (K030889)Inmed Ltda.2003-05-23
VIVOSONIC DIANOSTIC ULTRASOUND IMAGING COUPLING MEDIA (K020956)Microtek Medical, Inc.2002-05-16
UNI-PATCH ULTRASOUND COUPLING GEL (K021132)The Ludlow Company LP2002-05-15
WAVELENGHT ULTRASOUND LOTION (K013212)National Therapy Products, Inc.2002-02-25
POLYSONIC ULTRASOUND LOTION (K827296)Parker Laboratories, Inc.1982-04-16

Track MUI automatically

Every clearance here is in the API, with alerts when new ones post.