510(k) K032065 ยท MMP Cover, Barrier, Protective
MEDLINE BAND BAGS AND EQUIPMENT COVERS
| Applicant | Medline Industries, Inc., Waukegan IL, US |
| Decision | Substantially Equivalent, Sep 22, 2003 |
| Received | Jul 3, 2003 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K032065
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| 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 |
| Jul 20, 2023 | MEDLINE INDUSTRIES, LP - Northfield Medline Probe Cover Kits, Model Numbers: DYNJE5900, DYNJE5910, DYNJE5920, DYNJE5930, DYNJE5940, DYNJEX5900. for use during diagnostic ultrasound procedures Open, Classified |
MMP | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.