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 |
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jan 20, 2024 | Turkuaz Saglik Hizmetleri Medikal Temizlik Kim. Ur. San. ve Tic. A.S. REF: 126590, MEDLINE, STERILE ULTRASOUND GEL, 0.70 FL oz. (20 mL), QTY: 50, STERILER, CE 2292 Open, Classified |
MUI | K130581 |
| Sep 9, 2023 | Advance Medical Designs, Inc. 50-GEL20; Ultrasound gel Open, Classified |
MUI | K130581 |
| Sep 9, 2023 | Advance Medical Designs, Inc. ASG-001; Ultrasound gel Open, Classified |
MUI | K130581 |
| Aug 13, 2020 | Pharmaceutical Innovations, Inc. Ultra/Phonic Focus BP Conforming Gel Pads, UDI 00300361301021 (Primary); 10300361301028 (Package) - Product Usage: A gel pad for use on woman s areola during an ultrasound examination. Its primary pur Terminated |
MUI | None listed |
| May 24, 2012 | Pharmaceutical Innovations, Inc. Other-Sonic Generic Ultrasound Transmission Gel 5 Liters Hypoallergenic
Product Usage is a non-sterile gel used in ultrasound procedures to improve the transmission of the ultrasound signal from the Terminated |
MUI | None listed |
| May 24, 2012 | Pharmaceutical Innovations, Inc. Other-Sonic Generic Ultrasound Transmission Gel 250 mL
Hypoallergenic
Product Usage is a non-sterile gel used in ultrasound procedures to improve the transmission of the ultrasound signal from the tr Terminated |
MUI | None listed |
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