Company ยท US
Stryker Communications Corp
FDA 510(k) clearances and medical device recalls filed under this name, 2004 to 2013. Name variants (Inc, Corp, punctuation) are merged.
4510(k) clearances (0 in 12 months)
47recalls (1 in 12 months)
18recalls that name a 510(k)
Product codes
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Dec 30, 2013 | K132747 | VISUM BLADE LED SURGICAL LIGHTING SYSTEM Stryker Communications | FSY |
| May 6, 2010 | K100852 | STRYKER SWITCHPOINT INFINITY 3 CONTROL SYSTEM, MODEL: 067-8001-000 Stryker Communications | OCS |
| Apr 7, 2006 | K060802 | VISUM LED SURGICAL LIGHTING SYSTEM Stryker Communications Corp. | FSY |
| Sep 2, 2004 | K033132 | STRYKER SWITCHPOINT INFINITY Stryker Communications Corp. | GCJ |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Mar 27, 2026 | Stryker Communications Stryker CHROMOPHARE Softlit Ring Surgical Light System
REF: CH00000001 Open, Classified |
FSY | K120392 |
| Sep 24, 2025 | Stryker Communications Chromophare Surgical Light System, REF: CH00000001; SLX to Oculan NFC Upgrade Kit, REF: P60034 Open, Classified |
FSY | None listed |
| Apr 9, 2024 | Stryker Communications Chromophare Surgical Light System , REF CH00000001 Open, Classified |
FSY | K120392 |
| Jan 29, 2021 | Stryker Communications 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 Open, Classified |
FQO | None listed |
| Oct 11, 2019 | Stryker Communications Berchtold Chromophare Ceiling Mounted Surgical Light System, Catalog #CH13000000 Terminated |
FSY | None listed |
| Aug 30, 2019 | Stryker Communications Berchtold Chromophare Dual Monitor Carrier Arm or Dual Flat Panel, a component of Berchtold Chromophare Ceiling Mounted Surgical Light System. Terminated |
FSY | None listed |
| Mar 22, 2019 | Stryker Communications Berchtold Chromophare F628 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 Open, Classified |
FSY | None listed |
| Mar 22, 2019 | Stryker Communications 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 Open, Classified |
FSY | None listed |
| 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 | K060802 |
| Mar 1, 2018 | Stryker Communications 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 loc Terminated |
FSY | None listed |
| Jan 26, 2018 | Stryker Communications Berchtold Chromophare Dual Monitor Carrier Arm or Dual Flat Panel, a component of Berchtold Chromophare Ceiling Mounted Surgical Light System. Terminated |
FSY | None listed |
| Apr 21, 2017 | Stryker Communications 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 Terminated |
KZF | 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 | K060802 |
| Jul 15, 2014 | Stryker Communications BAM (SHAPE) ARM, RIGHT, 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 ar Terminated |
BRY | None listed |
| Jul 15, 2014 | Stryker Communications BAM (SHAPE) ARM, LEFT, 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 are Terminated |
BRY | None listed |
| Jul 15, 2014 | Stryker Communications SHAPE ARM, SINGLE WITH GCX MOUNT, 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 patie Terminated |
BRY | None listed |
| Jul 15, 2014 | Stryker Communications SHAPE ARM, DUAL SH2, 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 Terminated |
BRY | None listed |
| Jul 15, 2014 | Stryker Communications 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. Terminated |
BRY | None listed |
| Aug 21, 2013 | Stryker Communications Stryker Visum 300 Ceiling-mounted Exam Light. Terminated |
KZF | None listed |
| Jan 9, 2013 | Stryker Communications, Inc. (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 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 | K031068 K060802 |
| Oct 28, 2011 | Stryker Communications Corp Stryker Communications, 1410 Lakeside Parkway, # 100, Flower Mound, TX 75208
Stryker EDS (Equipment Delivery System) Booms and Flat Panel Suspensions are intended for use as ceiling-mounted devices t Terminated |
GCJ | K033132 |
| Oct 28, 2011 | Stryker Communications Corp Visum LED Surgical Lights/ Visum Halogen Surgical Lights.
Stryker Communications, 1410 Lakeside Parkway, # 100, Flower Mound, TX 75208
Visum LED Surgical Lights and Visum Halogen Surgical Lights ar Terminated |
FSY | K031068 |
| 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 | K060802 |
| Mar 8, 2011 | Stryker Communications Corp MMP 200 Articulating Booms, Catalog Number 0682-000-604SX, Product Number 0682-001-060C. Used for operating room equipment. Terminated |
None listed | |
| Jun 15, 2010 | Stryker Communications Corp 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 S Terminated |
GCJ | K033132 |
| May 21, 2010 | Stryker Communications Corp Ceiling Suspensions (Surgical Light and Flat Panel Suspensions); Catalog Numbers: 0682000863, 06820001009, 0682001010, 0682001076, 0682000864, 0682000857, 0682000858, 0682001077, 0682000865, 06820010 Terminated |
BRY | K031068 K033132 |
| May 21, 2010 | Stryker Communications Corp SwitchPoint Infinity (SPI) Control System. Catalog Numbers: 067000220, 067000230, 067000231, 067000232, & 067000233.
Used for direct control of room equipment, audio/video equipment, and indirect co Terminated |
GCJ | K031068 K033132 |
| May 21, 2010 | Stryker Communications Corp SwitchPoint Element (SPE) Control System. Control System for audio/video, surgical, and room equipment. Catalog Numbers: 067000220, 067000230, 067000231, 067000232, 067000233.
Used for direct contr Terminated |
GCJ | K031068 K033132 |
| May 21, 2010 | Stryker Communications Corp Stryker VISUM Halogen Surgical Lights (Ceiling Mounted Surgical Lights), Catalog Number: 0682000106; 0682000107.
Intended to illuminate the operative site during surgical procedures with high intens Terminated |
FSY | K031068 K033132 |
| May 21, 2010 | Stryker Communications Corp Stryker Equipment Delivery System (EDS); Ceiling Mounted Equipment Booms; Catalog Number: 0682000383, 0682000384, 0682000385(A-D), 0682000386(A-D), 0682000426, 0682000429(A-D), 0682000326, 0682000311 Terminated |
FSY | K031068 K033132 |
| May 21, 2010 | Stryker Communications Corp 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 l Terminated |
FSY | K031068 K033132 |
| May 14, 2010 | Stryker Communications Corp Universal Flat Panel Yoke, a component of the Stryker Flat Panel Arm. The yoke is intended to hold a flat panel monitor. Terminated |
BRY | None listed |
| Apr 6, 2010 | Stryker Communications Corp Vertier Surgical Table, Catalog numbers 0788100000, 0788100000S, 0788100001, and 0788100001S Terminated |
FQO | None listed |
| Aug 26, 2009 | Stryker Communications Corp 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 Sta Terminated |
FQO | None listed |
| Jul 13, 2009 | Stryker Communications Corp 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 typicall Terminated |
BRY | None listed |
| May 26, 2009 | Stryker Communications Corp 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, T Terminated |
FQO | None listed |
| Jan 16, 2009 | Stryker Communications Corp 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); distribute Terminated |
FQO | None listed |
| Oct 22, 2008 | Stryker Communications Corp 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 pa Terminated |
FQO | None listed |
| Sep 29, 2008 | Stryker Communications Corp 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 V Terminated |
GCJ | K033132 |
| Sep 18, 2008 | Stryker Communications Corp VERTIER Surgical Table, Catalog #0788-100-001S (SIDNE-enabled standard table with 5th wheel); distributed by Stryker Communications, Flower Mound, TX.
Is an AC powered, general purpose, mobile surgic Terminated |
FQO | None listed |
| Sep 18, 2008 | Stryker Communications Corp VERTIER Surgical Table, Catalog #0788-100-000S (SIDNE-enabled standard table); distributed by Stryker Communications, Flower Mound, TX.
Is an AC powered, general purpose, mobile surgical table with e Terminated |
FQO | None listed |
| Sep 18, 2008 | Stryker Communications Corp VERTIER Surgical Table, Catalog #0788-100-001 (Standard table with 5th wheel); distributed by Stryker Communications, Flower Mound, TX.
Is an AC powered, general purpose, mobile surgical table with e Terminated |
FQO | None listed |
| Sep 18, 2008 | Stryker Communications Corp 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-hydrauli Terminated |
FQO | None listed |
| Sep 17, 2008 | Stryker Communications Corp 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 a Terminated |
FQO | None listed |
| Jan 12, 2008 | Stryker Communications Extron Electronics OEM, CAB, DVI-I to DVI (3ft.); Part #: 43-112-01 (Stryker Part #: 0100-224-108); Distributed by Stryker Communications, Flower Mound, TX 75028. (These cables are commonly used wit Terminated |
GCJ | K033132 |
| Jan 12, 2008 | Stryker Communications Extron Electronics OEM, CAB, DVI-Male to DVI-Female Cable Assembly (14 inch.); Part #: 43-111-01 (Stryker Part #: 0100-224-131); Distributed by Stryker Communications, Flower Mound, TX 75028. (These Terminated |
GCJ | K033132 |