Home › COMPASS HEALTH BRANDS CORP. › GelShot
GelShot
COMPASS HEALTH BRANDS CORP. · Model GSA5CH2 · UDI-DI 00853904006391
10
510(k) clearances
70
Adverse events
6
Recalls
28
Facilities
Description
GelShot-/Adaptor-Chattanooga Intelect Legend 5 cm
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 |
Query this across every FDA database — by API.
Linked GUDID · 510(k)/PMA · MAUDE · recalls · establishments. Free tier, no card required.
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.