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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

DateFirmReason
2010-12-23Aspen 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.
2010-12-23Aspen 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.
2010-12-23Aspen 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.
2010-12-23Aspen 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.
2010-12-23Aspen 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.
2010-12-23Aspen 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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Data 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.