FDA Device Intelligence
Home › ICARE FINLAND OY › iCare IC100

iCare IC100

ICARE FINLAND OY · Model TA011 · UDI-DI 06430033852415

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

Description

The iCare IC100 tonometer is based on induction-based rebound method, which allows intraocular pressure (IOP) to be measured accurately, rapidly and without an anesthetic. The iCare IC100 tonometer is intended to be used for the measurement of intraocular pressure of the human eye.

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2014-09-08Instrumed International, Inc.The reason these devices are being withdrawn from the market by Instrumed is that Instrumed did not market these devices prior to September 26, 1976, and therefore, does not meet a
2014-09-08Instrumed International, Inc.The reason these devices are being withdrawn from the market by Instrumed is that Instrumed did not market these devices prior to September 26, 1976, and therefore, does not meet a

Query this across every FDA database — by API.

Linked GUDID · 510(k)/PMA · MAUDE · recalls · establishments. Free tier, no card required.

Get your free API keyRead the docs
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.