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Ambler Surgical
AMBLER SURGICAL CORP. · Model Freeman areola marker · UDI-DI 00190660104429
FZZ
Prescription
10
510(k) clearances
185
Adverse events
2
Recalls
184
Facilities
Description
Freeman areola marker, 38.0mm diameter
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2013-07-10 | Precision Dynamics Corporation | PDC Healthcare initiated this recall of Non-Sterile Viscot Part Number 1437-100 Surgical Skin Markers, becuase they were inadvertently mislabeled as PN STER-VIS Sterile Skin Marker |
| 2012-08-22 | Viscot Medical LLC | Dual Tip Marker has inconsistent ink flow on the black permanent ink side. |
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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.