Endoilluminator
Gastroenterology, Urology · 21 CFR 876.1500
Recent MDR events
270 adverse event reports on file
- CANALOPLASTY MICROCATHETER KIT ITRACK 250AJul 3, 2026InjuryNova Eye, Inc3005641545-2026-00013
- ITRACK ADVANCEJun 11, 2026InjuryNova Eye, Inc.3005641545-2026-00012
- ITRACK ADVANCEMay 7, 2026InjuryNova Eye, Inc.3005641545-2026-00008
- ITRACK ADVANCEMay 7, 2026InjuryNova Eye, Inc.3005641545-2026-00009
- ITRACK ADVANCEMay 7, 2026InjuryNova Eye, Inc.3005641545-2026-00010
- ITRACK ADVANCEMay 1, 2026InjuryNova Eye, Inc.3005641545-2026-00007
- ACCURUS HIGH BRIGHTNESS ILLUMINATOR SYSTEMApr 21, 2026MalfunctionAlcon Research, Llc - Irvine Technology Center2028159-2026-00548
- ITRACK ADVANCEApr 13, 2026InjuryNova Eye, Inc.3005641545-2026-00006
- ITRACK ADVANCEMar 30, 2026InjuryNova Eye, Inc.3005641545-2026-00004
- ITRACK ADVANCEMar 18, 2026InjuryNova Eye, Inc.3005641545-2026-00003
Event type breakdown
Registered firms
66 firms currently registered for this product code
Nova Eye Inc.
Fremont, CA, US
Bausch & Lomb Incorporated
Rochester, NY, US
Synergy Health Ede Bv
Venlo Limburg, NL
Katalyst Surgical, Llc
Chesterfield, MO, US
Peregrine Surgical, Llc.
New Britain, PA, US
Rose Gmbh Fuer Medizintechnik
Trier Rhineland-Palatinate, DE
Midwest Sterilization Corp.
JACKSON, MO, US
Fci Sas
BESANCON Doubs, FR
Iridex Corporation
MOUNTAIN VIEW, CA, US
Sterigenics Germany Gmbh
Wiesbaden Hesse, DE
Synergetics, Inc.
O Fallon, MO, US
Isomedix Operations Inc.
S Plainfield, NJ, US
Bausch & Lomb Incorporated
Saint Louis, MO, US
Harmac Medical Products, Inc./h3 De Tijuana, S. De Rl De C.v.
Tijuana Baja California, MX
Fci Sud
MAPOU LECLEZIO GOODLANDS Riviere du Rempart, MU
Sterigenics Belgium Petit Rechain S.a.
Verviers Liege, BE
Vortex Surgical, Inc.
Saint Charles, MO, US
510(k) clearances
40 clearances for this product code
- Alcon Laboratories, Inc.Dec 4, 2024
K242184 · Alcon 27GA Chandelier (8065000252); Alcon 27+ DS Wide Angle Endoilluminator (8065000253); Alcon 27+ DS Endoilluminator (8065000256);
- Peregrine Surgical, LLCAug 5, 2024
K233653 · Midfield Light Pipe, 23ga (3269.M06-00); Midfield Light Pipe, 25ga (3269.M05-00); Midfield Light Pipe, 27ga (3269.M04-00)
- Nova Eye Inc. (Business Name Nova Eye Medical)Mar 30, 2023
K221872 · ITrack Advance Canaloplasty Microcatheter with Advanced Delivery System
- Oculight , Ltd.Aug 20, 2021
K202670 · Nam illumination probe with chopper
- Peregrine Surgical , Ltd.Sep 11, 2015
K151604 · 23ga Chandelier Illuminator, 25ga Chandelier Illuminator
- SynergeticsFeb 24, 2015
K143123 · Synergetics PHOTON EX
- Iscience InterventionalJul 18, 2008
K080067 · ISCIENCE INTERVENTIONAL OPHTHALMIC MICROCATHETER
- Dutch Ophthalmic Research Center International BVOct 13, 2006
K062895 · XENON BRIGHTSTAR ILLUMINATION SYSTEM, MODEL 1266.XIII