510(k) K130581 ยท MUI Media, Coupling, Ultrasound
KONIX STERILE GEL
| Applicant | Turkuaz Saglik Hizmetleri Medikal Temizlik Kimyasa, San Francisco CA, US |
| Decision | Substantially Equivalent, Jun 18, 2014 |
| Received | Mar 5, 2013 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K130581
| 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 | None listed |
| Sep 9, 2023 | Advance Medical Designs, Inc. ASG-001; Ultrasound gel Open, Classified |
MUI | None listed |
| Sep 9, 2023 | Advance Medical Designs, Inc. 50-GEL20; Ultrasound gel Open, Classified |
MUI | None listed |
| Aug 3, 2023 | MEDLINE INDUSTRIES, LP - Northfield Medline Probe Cover Kits containing Turkuaz Ultrasound Gel, Labeled as the following:
a. COVER, PROBE, W/GEL AND BANDS, 4X48 - Model Number DYNJE5900;
b. COVER, PROBE, W/GEL AND BANDS, 6X24 - Mode Open, Classified |
MMP | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.