FDA Device Intelligence
HomeGLAUKOS CORPORATION › iStent

iStent

GLAUKOS CORPORATION · Model GTS100L · UDI-DI 00853704002012

OGO Prescription
0
510(k) clearances
2,671
Adverse events
4
Recalls
9
Facilities

Description

Trabecular Micro-bypass stent system - Left

Recalls

DateFirmReason
2018-08-28Alcon Research, LTD.Analysis of the completed dataset from the COMPASS-XT long-term study showed that the CyPass Micro-Stent group experienced statistically significant endothelial cell loss (ECL) com
2018-08-28Alcon Research, LTD.Analysis of the completed dataset from the COMPASS-XT long-term study showed that the CyPass Micro-Stent group experienced statistically significant endothelial cell loss (ECL) com
2018-08-28Alcon Research, LTD.Analysis of the completed dataset from the COMPASS-XT long-term study showed that the CyPass Micro-Stent group experienced statistically significant endothelial cell loss (ECL) com
2018-08-28Alcon Research, LTD.Analysis of the completed dataset from the COMPASS-XT long-term study showed that the CyPass Micro-Stent group experienced statistically significant endothelial cell loss (ECL) com

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.