HKYClass II

Tonometer, Manual

Ophthalmic · 21 CFR 886.1930

MDR events11All time

Recalls2All time

Registered firms106Currently listed

510(k) clearances56All time

Recent MDR events

11 adverse event reports on file

Event type breakdown

Injury5

Malfunction4

Other2

Most-reported manufacturers

Unspecified4 Haag-steit Usa Inc.1 Haag-streit Ag1 Icare Finald Oy1 Icare Finland Oy1 Keeler Ltd.1 S4 Optik Llc1 Storz Instrument Co.1

Recalls

2 recall events for this product code

Instrumed International, Inc.
TerminatedDec 16, 2014
Tonometers are manual devices intended to measure intraocular pressure by applying a known force on the globe of the eye and measuring the amount of indentation
The reason these devices are being withdrawn from the market by Instrumed is that Instrumed did not market these devices prior to September 26, 1976, and therefore, does not meet all FDA requirements to market the devices as "Pre-Amendment" devices.
Z-0558-2015 · View FDA record ↗
Instrumed International, Inc.
TerminatedDec 16, 2014
Schoitz weights are manual devices used with Schoitz tonometers and are intended to measure intraocular pressure by applying a known force on the globe of the e
The reason these devices are being withdrawn from the market by Instrumed is that Instrumed did not market these devices prior to September 26, 1976, and therefore, does not meet all FDA requirements to market the devices as "Pre-Amendment" devices.
Z-0559-2015 · View FDA record ↗

Registered firms

106 firms currently registered for this product code

510(k) clearances

56 clearances for this product code