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Applanation Tonometer

Trevi Technology, Inc. · Model AT · UDI-DI 00869228000441

HKY
1
510(k) clearances
11
Adverse events
2
Recalls
64
Facilities

Description

IBEX Tonometer is used for determining intraocular tension by measuring the pressure required to flatten a small area of the cornea.

Recalls

DateFirmReason
2014-09-08Instrumed International, Inc.The reason these devices are being withdrawn from the market by Instrumed is that Instrumed did not market these devices prior to September 26, 1976, and therefore, does not meet a
2014-09-08Instrumed International, Inc.The reason these devices are being withdrawn from the market by Instrumed is that Instrumed did not market these devices prior to September 26, 1976, and therefore, does not meet a

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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.