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KOWA Applanation Tonometer HA-2

KOWA COMPANY,LTD. · Model ATO-6K · UDI-DI 04987646803799

HKY Prescription
1
510(k) clearances
11
Adverse events
2
Recalls
63
Facilities

Description

For the measurement of intraocular pressure in the diagnosis of glaucoma.

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2014-09-08Instrumed International, Inc.The reason these devices are being withdrawn from the market by Instrumed is that Instrumed did not market these devices prior to September 26, 1976, and therefore, does not meet a
2014-09-08Instrumed International, Inc.The reason these devices are being withdrawn from the market by Instrumed is that Instrumed did not market these devices prior to September 26, 1976, and therefore, does not meet a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