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Hayden Medical

Hayden Medical, Inc. · Model E3-4004 · UDI-DI 00840319726471

HMR Prescription
5
510(k) clearances
21
Adverse events
6
Recalls
96
Facilities

Description

Alignment Gauge Marker with three blunt alignment pins to mark the 3, 6, & 9 o'clock positions, round knurled handle, 100mm overall length, stainless steel

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.