ClearanceBrief
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

CodeDeviceRecords
FSYLight, Surgical, Ceiling Mounted20
FQOTable, Operating-Room, Ac-Powered11
BRYCabinet, Table And Tray, Anesthesia8
GCJLaparoscope, General & Plastic Surgery8
KZFDevice, Medical Examination, Ac Powered2
OCSEndoscopic Video Imaging System/Component, Gastroenterology-Urology1

Latest 510(k) clearances

Decided510(k)Device and applicantCode
Dec 30, 2013K132747VISUM BLADE LED SURGICAL LIGHTING SYSTEM
Stryker Communications
FSY
May 6, 2010K100852STRYKER SWITCHPOINT INFINITY 3 CONTROL SYSTEM, MODEL: 067-8001-000
Stryker Communications
OCS
Apr 7, 2006K060802VISUM LED SURGICAL LIGHTING SYSTEM
Stryker Communications Corp.
FSY
Sep 2, 2004K033132STRYKER SWITCHPOINT INFINITY
Stryker Communications Corp.
GCJ

Latest recalls

DateFirm and productCodeLinked 510(k)
Mar 27, 2026Stryker Communications
Stryker CHROMOPHARE Softlit Ring Surgical Light System REF: CH00000001
Open, Classified
FSYK120392
Sep 24, 2025Stryker Communications
Chromophare Surgical Light System, REF: CH00000001; SLX to Oculan NFC Upgrade Kit, REF: P60034
Open, Classified
FSYNone listed
Apr 9, 2024Stryker Communications
Chromophare Surgical Light System , REF CH00000001
Open, Classified
FSYK120392
Jan 29, 2021Stryker 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
FQONone listed
Oct 11, 2019Stryker Communications
Berchtold Chromophare Ceiling Mounted Surgical Light System, Catalog #CH13000000
Terminated
FSYNone listed
Aug 30, 2019Stryker Communications
Berchtold Chromophare Dual Monitor Carrier Arm or Dual Flat Panel, a component of Berchtold Chromophare Ceiling Mounted Surgical Light System.
Terminated
FSYNone listed
Mar 22, 2019Stryker 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
FSYNone listed
Mar 22, 2019Stryker 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
FSYNone listed
Nov 13, 2018Stryker 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
FSYK060802
Mar 1, 2018Stryker 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
FSYNone listed
Jan 26, 2018Stryker Communications
Berchtold Chromophare Dual Monitor Carrier Arm or Dual Flat Panel, a component of Berchtold Chromophare Ceiling Mounted Surgical Light System.
Terminated
FSYNone listed
Apr 21, 2017Stryker 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
KZFNone listed
Mar 10, 2017Stryker 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
FSYK060802
Jul 15, 2014Stryker 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
BRYNone listed
Jul 15, 2014Stryker 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
BRYNone listed
Jul 15, 2014Stryker 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
BRYNone listed
Jul 15, 2014Stryker 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
BRYNone listed
Jul 15, 2014Stryker 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
BRYNone listed
Aug 21, 2013Stryker Communications
Stryker Visum 300 Ceiling-mounted Exam Light.
Terminated
KZFNone listed
Jan 9, 2013Stryker 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
FSYNone listed
Jan 26, 2012Stryker 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
FSYK031068
K060802
Oct 28, 2011Stryker 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
GCJK033132
Oct 28, 2011Stryker 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
FSYK031068
Oct 28, 2011Stryker 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
FSYK060802
Mar 8, 2011Stryker 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, 2010Stryker 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
GCJK033132
May 21, 2010Stryker Communications Corp
Ceiling Suspensions (Surgical Light and Flat Panel Suspensions); Catalog Numbers: 0682000863, 06820001009, 0682001010, 0682001076, 0682000864, 0682000857, 0682000858, 0682001077, 0682000865, 06820010
Terminated
BRYK031068
K033132
May 21, 2010Stryker 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
GCJK031068
K033132
May 21, 2010Stryker 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
GCJK031068
K033132
May 21, 2010Stryker 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
FSYK031068
K033132
May 21, 2010Stryker 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
FSYK031068
K033132
May 21, 2010Stryker 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
FSYK031068
K033132
May 14, 2010Stryker 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
BRYNone listed
Apr 6, 2010Stryker Communications Corp
Vertier Surgical Table, Catalog numbers 0788100000, 0788100000S, 0788100001, and 0788100001S
Terminated
FQONone listed
Aug 26, 2009Stryker 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
FQONone listed
Jul 13, 2009Stryker 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
BRYNone listed
May 26, 2009Stryker 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
FQONone listed
Jan 16, 2009Stryker 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
FQONone listed
Oct 22, 2008Stryker 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
FQONone listed
Sep 29, 2008Stryker 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
GCJK033132
Sep 18, 2008Stryker 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
FQONone listed
Sep 18, 2008Stryker 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
FQONone listed
Sep 18, 2008Stryker 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
FQONone listed
Sep 18, 2008Stryker 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
FQONone listed
Sep 17, 2008Stryker 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
FQONone listed
Jan 12, 2008Stryker 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
GCJK033132
Jan 12, 2008Stryker 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
GCJK033132
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