510(k) K060802 ยท FSY Light, Surgical, Ceiling Mounted
VISUM LED SURGICAL LIGHTING SYSTEM
| Applicant | Stryker Communications Corp., Flower Mound TX, US |
| Decision | Substantially Equivalent, Apr 7, 2006 |
| Received | Mar 24, 2006 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K060802
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Nov 13, 2018 | Stryker Communications EDS Light Suspension, Central Axis, a component of the Stryker Visum LED Surgical Lighting System, with the following catalog numbers: 0682001286, EDS Light Suspension, Central Axis, 5P/FP; 068200129 Open, Classified |
FSY | None listed |
| Mar 10, 2017 | Stryker Communications The Stryker Visum LED Surgical Lighting system is intended to illuminate the operative site during surgical procedures with high intensity light. Affected part numbers are 0682001432 (EDS LIGHT SUSPEN Terminated |
FSY | None listed |
| Jan 26, 2012 | Stryker Communications Corp Visum LED Surgical Lights, Ceiling Mounted Surgical Light. The Visum LED surgical light is intended to illuminate the operative site during surgical procedures with high intensity light. Terminated |
FSY | None listed |
| Oct 28, 2011 | Stryker Communications Corp SwitchPoint Infinity Control System
Stryker Communications, 1410 Lakeside Parkway, # 100, Flower Mound, TX 75208
The SwitchPoint Infinity (SPI) Control System is an integrated voice, video, data rou Terminated |
FSY | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.