Stryker Communications, Inc.

FDA Regulatory Profile

Summary

Total Recalls
19
510(k) Clearances
4
Inspections
5
Compliance Actions
0

Recent Recalls

NumberClassProductDate
Z-2620-2025Class IIChromophare Surgical Light System, REF: CH00000001; SLX to Oculan NFC Upgrade Kit, REF: P60034July 15, 2025
Z-1506-2024Class IIChromophare Surgical Light System , REF CH00000001February 8, 2024
Z-1297-2021Class IIS-Series Equipment Management System; Model Number(s):0682400550; UDI: 07613327400502 Components thJanuary 29, 2021
Z-1602-2020Class IIBerchtold Chromophare Ceiling Mounted Surgical Light System, Catalog #CH13000000October 11, 2019
Z-2446-2019Class IIBerchtold Chromophare Dual Monitor Carrier Arm or Dual Flat Panel, a component of Berchtold ChromophAugust 1, 2019
Z-2540-2019Class IIBerchtold Chromophare F628 Surgical Lights. Product Usage: The medical lights are for usage inMarch 22, 2019
Z-2539-2019Class IIBerchtold Chromophare F528 Surgical Lights. Product Usage: The medical lights are for usage inMarch 22, 2019
Z-1388-2019Class IIEDS Light Suspension, Central Axis, a component of the Stryker Visum LED Surgical Lighting System, wNovember 13, 2018
Z-0828-2018Class IIBerchtold Chromophare Ceiling Mounted Surgical Light System, Catalog #CH13000000. Product Usage: January 29, 2018
Z-0692-2018Class IIBerchtold Chromophare Dual Monitor Carrier Arm or Dual Flat Panel, a component of Berchtold ChromophJanuary 26, 2018
Z-2248-2017Class IIBerchtold Chromophare F300 Exam Light CHROMOPHARE examination lights are medical lights used for loApril 21, 2017
Z-1699-2017Class IIThe Stryker Visum¿ LED Surgical Lighting system is intended to illuminate the operative site during February 28, 2017
Z-2053-2014Class IISHAPE ARM, DUAL SH2, an articulating, arm bracket that is attached to the service head of boom systeMarch 17, 2014
Z-2052-2014Class IISHAPE ARM, SINGLE, an articulating, arm bracket that is attached to the service head of boom systemsMarch 17, 2014
Z-2054-2014Class IISHAPE ARM, SINGLE WITH GCX MOUNT, an articulating, arm bracket that is attached to the service head March 17, 2014
Z-2055-2014Class IIBAM (SHAPE) ARM, LEFT, an articulating, arm bracket that is attached to the service head of boom sysMarch 17, 2014
Z-2056-2014Class IIBAM (SHAPE) ARM, RIGHT, an articulating, arm bracket that is attached to the service head of boom syMarch 17, 2014
Z-1992-2013Class IIStryker Visum 300 Ceiling-mounted Exam Light.July 25, 2013
Z-0657-2013Class II(l) Visum Halogen Surgical Light, (2) Visum LED Surgical Light, (3) Stryker Flat Panel and NavigatiSeptember 25, 2012

Recent 510(k) Clearances

K-NumberDeviceDate
K132747VISUM BLADE LED SURGICAL LIGHTING SYSTEMDecember 30, 2013
K100852STRYKER SWITCHPOINT INFINITY 3 CONTROL SYSTEM, MODEL: 067-8001-000May 6, 2010
K060802VISUM LED SURGICAL LIGHTING SYSTEMApril 7, 2006
K033132STRYKER SWITCHPOINT INFINITYSeptember 2, 2004