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Falck Medical Multi-Function Applanation Tonometer

FALCK MEDICAL INC · Model FMAT1 · UDI-DI 00867009000208

HKY Prescription
10
510(k) clearances
11
Adverse events
2
Recalls
64
Facilities

Description

Indications for Use: Intraocular Pressure, Ocular Pulse Amplitude, Ophthalmodynamometry and Tonography Measurement

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2014-09-08Instrumed International, Inc.The reason these devices are being withdrawn from the market by Instrumed is that Instrumed did not market these devices prior to September 26, 1976, and therefore, does not meet a
2014-09-08Instrumed International, Inc.The reason these devices are being withdrawn from the market by Instrumed is that Instrumed did not market these devices prior to September 26, 1976, and therefore, does not meet a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