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Anodyne Surgical

Psi/Eye-Ko, Inc. · Model CK2001 · UDI-DI 00840516145808

HMR
5
510(k) clearances
18
Adverse events
6
Recalls
96
Facilities

Description

Gimbel-Mendez Beveled Deg Gauge w/ teeth, 5 Deg Ruler markings on top of Unique bev labeled at 30 Deg increments, Rnd Knurled Handle, 117mm Lgth, Ti w/ SS color

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.