Home › M.D.L. S.R.L. › Mark
Mark
M.D.L. S.R.L. · Model PN2010 · UDI-DI 08056138586222
GDF
Prescription
10
510(k) clearances
227
Adverse events
20
Recalls
236
Facilities
Description
NON-REPOSITIONAL DISPOSABLE NEEDLE 20G x 100 mm FOR MAMMARY NODULE LOCALIZATION, WITH SINGLE HOOK
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. |
| 2021-08-05 | M.D.L. S.r.l. | Sterility assurance may be compromised. |
| 2017-03-28 | Bard Peripheral Vascular Inc | It may be at risk of containing a non-MR compatible GHIATAS Beaded Breast Localization Wire instead of a MR compatible GHIATAS Beaded Breast Localization Wire. |
| 2016-08-02 | Hologic, Inc | Tip Breakage at the glue joint between the obturator body and tip |
| 2016-08-02 | Hologic, Inc | Tip Breakage at the glue joint between the obturator body and tip |
| 2016-02-04 | Stryker Instruments Div. of Stryker Corporation | During an evaluation of the product packaging, it was determined that there is a potential for the product to cause damage to the packaging, creating a possible breach in sterility |
| 2016-02-04 | Stryker Instruments Div. of Stryker Corporation | During an evaluation of the product packaging, it was determined that there is a potential for the product to cause damage to the packaging, creating a possible breach in sterility |
| 2016-02-04 | Stryker Instruments Div. of Stryker Corporation | During an evaluation of the product packaging, it was determined that there is a potential for the product to cause damage to the packaging, creating a possible breach in sterility |
| 2016-02-04 | Stryker Instruments Div. of Stryker Corporation | During an evaluation of the product packaging, it was determined that there is a potential for the product to cause damage to the packaging, creating a possible breach in sterility |
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.