510(k) K014022 ยท IYE Accelerator, Linear, Medical
MRI LINE MARKER
| Applicant | I.Z.I. Corp., Baltimore MD, US |
| Decision | Substantially Equivalent, Mar 4, 2002 |
| Received | Dec 6, 2001 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K014022
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Sep 26, 2022 | Mckesson Medical-Surgical Inc. Corporate Office Skin markers:
a. IZI MEDICAL PRODUCTS LLC Multi-Modality Markers SKIN MARKER RADIO 1.5MM 50BX Catalog #MM3005.
b. SKIN MARKER MAMMO BB2.0 100B - Mammography Skin Marker Catalog # SDM-BB20. Open, Classified |
IYE | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.