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GelShot
COMPASS HEALTH BRANDS CORP. · Model GS908 · UDI-DI 00850958007602
10
510(k) clearances
70
Adverse events
6
Recalls
28
Facilities
Description
Chattanooga Intelect XT 5cm Sample Kit- French
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 product on April 18, 2012 |
| 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 product on April 18, 2012 |
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Get your free API keyRead the docsData compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.