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Tono-Pen® XL
REICHERT, INC. · Model 230635 · UDI-DI 00812559010092
HKY
Prescription
1
510(k) clearances
11
Adverse events
2
Recalls
64
Facilities
Description
Handheld, battery-powered, contact tonometer. Indications for use include measuring intraocular pressure (IOP) for suspected glaucoma, or when increased intraocular pressure is suspected.
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2014-09-08 | Instrumed International, Inc. | The reason these devices are being withdrawn from the market by Instrumed is that Instrumed did not market these devices prior to September 26, 1976, and therefore, does not meet a |
| 2014-09-08 | Instrumed International, Inc. | The reason these devices are being withdrawn from the market by Instrumed is that Instrumed did not market these devices prior to September 26, 1976, and therefore, does not meet a |
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