Data / Medical devices / United States / STRYKER Communications, Inc.
STRYKER Communications, Inc.: FDA-registered device maker in Flower Mound, TX, United States, 5 510(k) clearances
STRYKER Communications, Inc. is registered with the FDA (registration 2031963) in Flower Mound, TX, United States. It lists 14 device types. The FDA files 5 510(k) clearances under its listings, the newest dated November 4, 2021. 30 recall events name it as the recalling firm. Registered through 2027. FDA data exported November 2, 2026.
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- FDA registration number
- 2031963
- FEI number
- 3002975342
- Address
- 571 Silveron Blvd., Flower Mound, TX, United States, 75028
- Owner or operator
- STRYKER CORP. (1811755)
- Roles
- Complaint file establishment, Manufacturer, Specification developer
- First device listed
- December 26, 1992
- Registered through
- 2027
- Brand names listed
- 0502-000-003 ThermaClear Spine, 0502-500-001 ThermaClear Main Module, ACCEND Cardanic Caps, ACCEND Cardanic Control Repair, ACCEND Ceiling Cover, ACCEND Ceiling Cover Hardware, ACCEND Conduit Termination Plate, ACCEND DROP TUBE HARDWARE KIT and more
Devices it lists
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| November 4, 2021 | K210628 | X-FLO Fluid Management System | HIG | Substantially Equivalent | Thermedx, LLC | accessdata.fda.gov |
| December 30, 2013 | K132747 | VISUM BLADE LED SURGICAL LIGHTING SYSTEM | FSY | Substantially Equivalent | Stryker Communications | accessdata.fda.gov |
| April 7, 2006 | K060802 | VISUM LED SURGICAL LIGHTING SYSTEM | FSY | Substantially Equivalent | Stryker Communications Corp. | accessdata.fda.gov |
| May 17, 2005 | K050322 | MICROTEK EQUIPMENT DRAPES | KKX | Substantially Equivalent | Microtek Medical, Inc. | accessdata.fda.gov |
| August 12, 2003 | K031068 | STRYKER VISUM SURGICAL LIGHTING SYSTEM | FSY | Substantially Equivalent | Stryker Endoscopy | accessdata.fda.gov |
Recalls
Recall events where this establishment is the recalling firm, matched on its FEI.
| Initiated | Event | Class | Status | Product | Reason | Source |
|---|---|---|---|---|---|---|
| February 23, 2026 | 98514 | Class II | Ongoing | Stryker CHROMOPHARE Softlit Ring Surgical Light System REF: CH00000001 | Surgical light assembly may not adequate support the weight of the ceiling cover. | accessdata.fda.gov |
| July 15, 2025 | 97285 | Class II | Ongoing | Chromophare Surgical Light System, REF: CH00000001; SLX to Oculan NFC Upgrade Kit, REF: P60034 | Surgical lights have stress lines forming on the powder coating, which indicates that powder coating chipping can occur. | accessdata.fda.gov |
| February 8, 2024 | 94199 | Class II | Ongoing | Chromophare Surgical Light System, REF CH00000001 | Due to insufficient mounting force the stability of surgical light system cannot be guaranteed. | accessdata.fda.gov |
| January 29, 2021 | 87331 | Class II | Ongoing | S-Series Equipment Management System; Model Number(s):0682400550; UDI: 07613327400502 Components that are affected within the S-Series Finished Good Model Number o P38198 - ASM, MFR CONTROLLER, FIXED STANDARD o P38199 - | The manufacturer has become aware that there is a likelihood that the S-Series Equipment Management System Capacitive Touch Controls on the MFRs rotational electrical magnetic brakes may disengage when an electrocautery device is in use. | accessdata.fda.gov |
| October 11, 2019 | 85083 | Class II | Terminated | Berchtold Chromophare Ceiling Mounted Surgical Light System, Catalog #CH13000000 | The firm has become aware that there is a likelihood that a missing snap ring or spanner nut may result in an insufficient mount force that causes the surgical light to fall. If the suspension of the surgical light falls, it may potentially cause serious injuries to Health Care Providers and/or patients. | accessdata.fda.gov |
| August 1, 2019 | 83510 | Class II | Terminated | Berchtold Chromophare Dual Monitor Carrier Arm or Dual Flat Panel, a component of Berchtold Chromophare Ceiling Mounted Surgical Light System. | The mounts on the monitor may have an insufficient weld. | accessdata.fda.gov |
| March 22, 2019 | 83355 | Class II | Ongoing | Berchtold Chromophare F528 Surgical Lights. Product Usage: The medical lights are for usage in hospital treatment rooms. They provide localized lighting focused on the patient s body for detecting and treating disease, i | The back cover of the light head was insufficiently assembled and could potentially fall off the light. | accessdata.fda.gov |
| November 13, 2018 | 82476 | Class II | Ongoing | 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; 0682001298, EDS Light Suspensi | There is a potential the joint in the suspension of the device is insufficiently assembled. | accessdata.fda.gov |
| January 29, 2018 | 79251 | Class II | Terminated | Berchtold Chromophare Ceiling Mounted Surgical Light System, Catalog #CH13000000. Product Usage: Chromophare surgical lights are medical lights for usage in hospital treatment rooms. They provide localized lighting focus | The device could have a missing spanner nut and snap ring which could potentially result in the equipment falling. | accessdata.fda.gov |
| January 26, 2018 | 79116 | Class II | Terminated | Berchtold Chromophare Dual Monitor Carrier Arm or Dual Flat Panel, a component of Berchtold Chromophare Ceiling Mounted Surgical Light System. | The mounts on the monitor may have an insufficient (missing or incomplete) weld. | accessdata.fda.gov |
| April 21, 2017 | 77261 | Class II | Terminated | Berchtold Chromophare F300 Exam Light CHROMOPHARE examination lights are medical lights used for local illumination of the patients' body so that illnesses, injuries and disabilities can be diagnosed and treated | The exam light may have a tolerance issue with the adapter assembly, which could potentially not allow the snap ring to be seated correctly. If this is the case, there could be insufficient mount force that may cause the equipment to fall, resulting in serious injury. | accessdata.fda.gov |
| February 28, 2017 | 76633 | Class II | Terminated | 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 SUSPENSION, CENTRAL AXIS, | The potential hazard that can arise for the combination of the missing screws and the overloading by the end user is insufficient mount force that causes the equipment to fall. | accessdata.fda.gov |
| March 17, 2014 | 67813 | Class II | Terminated | SHAPE ARM, SINGLE, an articulating, arm bracket that is attached to the service head of boom systems which are used for supporting and positioning equipment in operating rooms and patient care areas. The product comes as | During the use of the SHAPE Arm there is the potential for the monitor mount to come off of the SHAPE Arm if the lock washer and screw are not present. | accessdata.fda.gov |
| July 25, 2013 | 65888 | Class II | Terminated | Stryker Visum 300 Ceiling-mounted Exam Light. | Potential incomplete final weld on the drop tube flange. | accessdata.fda.gov |
| September 25, 2012 | 63355 | Class II | Terminated | (l) Visum Halogen Surgical Light, (2) Visum LED Surgical Light, (3) Stryker Flat Panel and Navigation Arm The Spring Arm Circlip is part of the Stryker Spring Arm used in multiple configurations as a component of the (1) | Stryker has become aware that there is a low likelihood of incomplete engagement of the Spring Arm Circlip during service or replacement of the Spring Arm. If the Spring Arm Circlip is not fully seated, the Spring Arm could separate and fall along with the surgical lights or monitors mounted to the end of the Spring Arm. To date, there have been no serious i | accessdata.fda.gov |
| November 7, 2011 | 60812 | Not yet classified | Terminated | 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. | Stryker has identified a potential structural issue with the Visum LED surgical light(s). During a complaint investigation, Stryker became aware that there was a possibility that incorrect assembly could result in the light head beginning to separate from the suspension arm. In the event the light separates and falls from the arm, it could lead to serious in | accessdata.fda.gov |
| August 23, 2011 | 59866 | Not yet classified | Terminated | 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 router and teleconferenci | Installation records for the SwitchPoint Infinity, Booms, Lights, and Flat Panel systems are incomplete or inadequate. | accessdata.fda.gov |
| January 28, 2011 | 58045 | Not yet classified | Terminated | MMP 200 Articulating Booms, Catalog Number 0682-000-604SX, Product Number 0682-001-060C. Used for operating room equipment. | Utilization of incorrect screws resulted in inadequate thread engagement reducing the load bearing capability of the product. | accessdata.fda.gov |
| April 30, 2010 | 55624 | Not yet classified | Terminated | The SwitchPoint Infinity 2 (SPI2) and SwitchPoint Element (SPE), an integrated voice, video, data router and teleconferencing interface for the operating room. The SwitchPoint Infinity 2 (SPI2) and SwitchPoint Element (S | Users may experience issues with the functionality of the SwitchPoint Infinity 2 and SwitchPoint Element that may be exhibited as a "Page Not Found" error message, missing drop down options, or a frozen touch panel. | accessdata.fda.gov |
| April 15, 2010 | 55477 | Not yet classified | Terminated | Stryker VISUM LED Surgical Lights (Ceiling Mounted Surgical Light), Catalog numbers: 0682001250, 0682001251. Intended to illuminate the operative site during surgical procedures with high intensity light. | Installation records are incomplete. | accessdata.fda.gov |
| April 7, 2010 | 55498 | Not yet classified | Terminated | Universal Flat Panel Yoke, a component of the Stryker Flat Panel Arm. The yoke is intended to hold a flat panel monitor. | Some of the pitch shafts were not properly welded which results in the monitor becoming unlevel. | accessdata.fda.gov |
| November 13, 2009 | 53993 | Not yet classified | Terminated | Vertier Surgical Table, Catalog numbers 0788100000, 0788100000S, 0788100001, and 0788100001S | In certain positions, product is susceptible to fluid instrusion which could possibly result in short circuit or unsolicited movement. | accessdata.fda.gov |
| May 19, 2009 | 52099 | Not yet classified | Terminated | Amico E-Cylinder Canister Holder, distributed by Stryker Communications, Flower Mound, TX 75028. Canister holder is used to hang E-Cylinders (pressurized gas canisters) from a boom. Product typically used in the surgical | Design flaw on the E-Cylinder canister holder may result in early fatigue and failure of the bracket screws, which could cause the cage to become detached from its mount and fall. | accessdata.fda.gov |
| May 8, 2009 | 51994 | Not yet classified | Terminated | Surgical Table Headrest, Catalog/Part #0788-300-012, component of VERTIER Surgical Table. Distributed as part of the VERTIER Surgical Tables or individually by Stryker Communications, Flower Mound, TX 75028. The Vertier | Potential for health care provider/hospital staff member to sustain injury to fingers or hands when removing/handling the headrest component of the VERTIER Surgical Table. | accessdata.fda.gov |
| November 13, 2008 | 52712 | Not yet classified | Terminated | Vertier Surgical Table, an AC powered, general purpose, mobile surgical table with electro-hydraulically controlled movements which are part of a control feedback system. Part Numbers: 0788100000 Standard table, 07881000 | Surgical tables were produced using an unapproved tilt frame bushing. | accessdata.fda.gov |
| September 5, 2008 | 49514 | Not yet classified | Terminated | Circlip component of the Stryker Flat Panel and Navigation Arm System. Stryker Flat Panel and Navigation Arm System are intended for use as a ceiling-mounted device to support a medical grade flat panel monitor or camera | Circlip component used to suspend flat panel and navigation arm system may become dislodged. | accessdata.fda.gov |
| September 2, 2008 | 49568 | Not yet classified | Terminated | Stryker Vision 3 Flat Panel Shroud, Part #0682-000-414 (Individual Flat Panel Shroud, Ver. 2, Reworked), 0682-000-415 (SV3 Shroud Retro Fit Kit) and 0682-000-416 (Flat Panel Retro Fit Kit); distributed by Stryker Communi | Paint chips: Shroud used to cover cables on the Stryker Vision 3 flat panel monitor (monitor used in surgery rooms during procedures) was not manufactured/painted to specification, resulting in the possibility that paint chips could fall off and fall into non-sterile and/or sterile fields during surgery. For further information, please contact Stryker Commun | accessdata.fda.gov |
| July 2, 2008 | 49021 | Not yet classified | Terminated | VERTIER Surgical Table, Catalog #0788-100-000 (Standard table); distributed by Stryker Communications, Flower Mound, TX. Is an AC powered, general purpose, mobile surgical table with electro-hydraulically controlled move | Hydraulic lines responsible for tilting the surgical table have the potential to be severed when articulating table to its lowest position, possibly resulting in the unexpected and rapid movement of the table. | accessdata.fda.gov |
| May 1, 2008 | 48197 | Not yet classified | Terminated | Surgical Table Column Casing Revision B, Product #0788-200-001 Revision B; component of Stryker's VERTIER Surgical Table distributed by Stryker Communications, Flower Mound, TX 75028. The tables are AC-powered or air-pow | Potential exists for energy chain, which is responsible for protecting hydraulic and electrical cables during up and down motion on VERTIER Surgical Table, to become lodged between column case sections resulting in possible reduction or lose of function to hand and/or foot controls or possible involuntary movement of the table. | accessdata.fda.gov |
| April 1, 2008 | 49368 | Not yet classified | Terminated | OPHIT Optical Digital Visual Interface (DVI) Extender, Part number 0100224051, a component of the Switchpoint Infinity 1, Switchpoint Infinity 2, and Switchpoint Element. The OPHIT Optical Digital Visual Interface (DVI) | Product at times experiences intermittent signal loss due to electromagnetic interference. | accessdata.fda.gov |
Compare with other makers
- All makers of Light, Surgical, Ceiling Mounted
- All makers of Table, Operating-Room, Ac-Powered
- All makers of Stirrups
- All makers of Support, Patient Position
- All makers of Camera, Surgical And Accessories
- All makers of Surgical Table Cushion
Updated March 27, 2026. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.