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Ambler Surgical
AMBLER SURGICAL CORP. · Model Ambler axis marker · UDI-DI 00190660217693
HMR
Prescription
5
510(k) clearances
21
Adverse events
6
Recalls
96
Facilities
Description
Ambler axis marker, 7.9mm diameter outter ring, 3.8mm diameter inner ring, 4 blades, with cross hairs, round handle
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2010-12-23 | Aspen Surgical Products, Inc. | Fragments from the pad may disengage and stick to the instrument. The condition could cause fragments to come into contact with the intact cornea prior to surgery. |
| 2010-12-23 | Aspen Surgical Products, Inc. | Fragments from the pad may disengage and stick to the instrument. The condition could cause fragments to come into contact with the intact cornea prior to surgery. |
| 2010-12-23 | Aspen Surgical Products, Inc. | Fragments from the pad may disengage and stick to the instrument. The condition could cause fragments to come into contact with the intact cornea prior to surgery. |
| 2010-12-23 | Aspen Surgical Products, Inc. | Fragments from the pad may disengage and stick to the instrument. The condition could cause fragments to come into contact with the intact cornea prior to surgery. |
| 2010-12-23 | Aspen Surgical Products, Inc. | Fragments from the pad may disengage and stick to the instrument. The condition could cause fragments to come into contact with the intact cornea prior to surgery. |
| 2010-12-23 | Aspen Surgical Products, Inc. | Fragments from the pad may disengage and stick to the instrument. The condition could cause fragments to come into contact with the intact cornea prior to surgery. |
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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.
