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Castroviejo Caliper (non glare)

Oculo-Plastik Inc · Model 25-140 · UDI-DI 10697660003518

FTY
10
510(k) clearances
436
Adverse events
5
Recalls
403
Facilities

Description

The Caliper is a measuring instrument intended to measure the skin or the eyelids' muscles that the surgeon wants to remove or shorten. The instrument touches directly onto the patient's eyelid and tissue that will be operated. It is partially non-glare: the ruler is not surface treated. It is usually used before the laser. Full scale is 20 mm and resolution is 0.5 mm.

Recalls

DateFirmReason
2015-03-05SpineFrontier, Inc.The PedFuse Pedicle Screw Rod Caliper included with the MISquito Pedicle Screw System may be used incorrectly as the Surgical Technique does not adequately convey the intended use
2010-10-22Lemaitre Vascular, Inc.Box label (Top Part). Lot and Expiration Date information were switched.
2010-10-22Lemaitre Vascular, Inc.Box label (Top Part). Lot and Expiration Date information were switched.
2010-10-22Lemaitre Vascular, Inc.Box label (Top Part). Lot and Expiration Date information were switched.
2010-10-22Lemaitre Vascular, Inc.Box label (Top Part). Lot and Expiration Date information were switched.

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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.