ClearanceBrief
Panels › General, Plastic Surgery › Product code FSY · Class 2

Light, Surgical, Ceiling Mounted

Regulation 878.4580

0510(k)s in 12 months (74 all time)
5recalls in 12 months (454 all time)
42recalls that name a 510(k)
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Top companies in FSY

DateFirm and productCodeLinked 510(k)
Sep 18, 2026Maquet SAS
PowerLED 300 Concealed Lighting System (PWD30+SF W K3 SPRING ARM A2 FC3 50-100nm) Model Numbers: 1. ARD568474114A, 2. ARD567501286;
Open, Classified
FSYK070442
Jun 15, 2026Steris Corporation
ALYON Surgical Lighting System
Open, Classified
FSYNone listed
Jun 15, 2026Steris Corporation
HarmonyAIR A-Series Surgical Lighting System
Open, Classified
FSYNone listed
Jun 15, 2026Steris Corporation
HarmonyAIR A-Series Surgical Lighting System
Open, Classified
FSYNone listed
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
Jul 25, 2025Steris Corporation
Dual Flat Panel Monitor (DFPM) accessories for HarmonyAIR E-Series Surgical Lighting Systems
Open, Classified
FSYNone listed
Jul 25, 2025Steris Corporation
Dual Flat Panel Monitor (DFPM) accessories for HarmonyAIR A-Series Surgical Lighting Systems
Open, Classified
FSYNone listed
Aug 14, 2024DKK Dai-Ichi Shomei Co., Ltd.
Aurora 4 Series, Aurora 7 lighthead; Models: AUA7 (including TV models). The Aurora Series is intended to illuminate the surgical field and ensure visibility of the surgical site.
Open, Classified
FSYK071698
Aug 14, 2024DKK Dai-Ichi Shomei Co., Ltd.
Aurora 3 Series, Aurora 7 lighthead; Models: AUT7 (including TV models). The Aurora Series is intended to illuminate the surgical field and ensure visibility of the surgical site.
Open, Classified
FSYK071698
Aug 14, 2024DKK Dai-Ichi Shomei Co., Ltd.
Aurora 2 Series, Aurora 7 lighthead; Models: AUR7 (including TV models). The Aurora Series is intended to illuminate the surgical field and ensure visibility of the surgical site.
Open, Classified
FSYK071698
Aug 14, 2024DKK Dai-Ichi Shomei Co., Ltd.
Aurora Series, Aurora 7 lighthead; Models: LED7 (including TV models). The Aurora Series is intended to illuminate the surgical field and ensure visibility of the surgical site.
Open, Classified
FSYK071698
Apr 9, 2024Stryker Communications
Chromophare Surgical Light System , REF CH00000001
Open, Classified
FSYK120392
Jan 19, 2024Getinge Usa Sales Inc
Maquet Hanaulux 2006/ 2007, Blue 100, Blue 130/ 90, Blue Series 30/ 80, and Prismatic OR Light Systems. No Model Numbers.
Open, Classified
FSYNone listed
Jan 19, 2024Getinge Usa Sales Inc
Maquet Blueline Series 30/80 OR Light Systems, Model Numbers and Catalog Numbers BLUE 30 - ARD569015111A, BLUE 30 - ARD569015111C, BLUE 30 - ARD569015131C, BLUE 30 - ARD569025111C, BLUE 30 - ARD569025
Open, Classified
FSYK954169
K970886
Jan 19, 2024Getinge Usa Sales Inc
Maquet G8 / G8E OR Light Systems, Model Numbers and Catalog Numbers G8 LC E - ARD568131211C, G8G8 DF E - ARD568121111C, G8G8FS DF - ARD568121131C
Open, Classified
FSYNone listed
Jan 19, 2024Getinge Usa Sales Inc
Maquet Hanaulux HLX2000 OR Light Systems, Model Numbers and Catalog Numbers 3001 - ARD567424001C, 3001 HMS07 - ARD567722001C, 3001 HXS12 - ARD567703001C, 4001 S/DF - ARD567211211C, 4001 SAD/DF - ARD56
Open, Classified
FSYK932451
Jan 19, 2024Getinge Usa Sales Inc
Maquet Prismalix OR Light Systems, Model Numbers and Catalog Numbers 3001 - ARD567424001C, 3001 HMS07 - ARD567722001C, 3001 HXS12 - ARD567703001C, 4001 S/DF - ARD567211211C, 4001 SAD/DF - ARD567221211
Open, Classified
FSYK982063
Jan 19, 2024Getinge Usa Sales Inc
Maquet XTen OR Light Systems, Model Numbers and Catalog Numbers 3001 HMD14 - ARD567732001C, X TEN DUO - ARD568221510C, X TEN DUO - ARD568221561C, X10AXL DF - ARD568211010C, X10AXL SF - ARD568231010C,
Open, Classified
FSYK040735
Jan 19, 2024Getinge Usa Sales Inc
Maquet Hanaulux HLX3000 OR Light Systems, Model Numbers and Catalog Numbers H3 BC - HM567811111C
Open, Classified
FSYNone listed
Jan 19, 2024Getinge Usa Sales Inc
Maquet Axcel / Axcel + OR Light Systems, Model Numbers and Catalog Numbers AXL 5001 - ARD567501961C, AXL 5001S - ARD567505961C, AXL 5002 - ARD567501962C, AXL 5002S - ARD567505962C, AXL 5501 - ARD56750
Open, Classified
FSYK030906
Jan 19, 2024Getinge Usa Sales Inc
Maquet PowerLED/HLED and PowerLED300 OR Light Systems, Model Numbers and Catalog Numbers EPS MB1 - ARDINT059002A, EPS MB1 - ARDINT059002C, EPS MB1 TR - ARDINT059000A, EPS MB1 TR - ARDINT059000C, EPS M
Open, Classified
FSYK070442
Oct 6, 2023DKK Dai-Ichi Shomei Co., Ltd.
LFS Flat screen support arm systems without surgical lamp for models Aurora series, Aurora 2 series, Aurora 3 series, Aurora 4 series, Aurora Astro series, Stellar XL, and Stellar series, LFS Flat Scr
Open, Classified
FSYNone listed
Oct 6, 2023DKK Dai-Ichi Shomei Co., Ltd.
LFS Flat screen arm system with surgical lamp for Models Aurora series, Aurora 2 series, Aurora 3 series, Aurora 4 series, Aurora Astro series, Stellar XL, and Stellar series, LFS Flat Screen Arm Syst
Open, Classified
FSYNone listed
Jun 30, 2022Getinge Usa Sales Inc
VOLISTA StandOP Surgical Light, Product Code/Part Numbers ARD568811901 VLT600SF AIM STP ARD568811911 VLT600SF AIM STP ARD568811961 VLT600DF AIM STP ARDVST229000A VST60SF AIM ARDVST229001A VST60DF AIM
Open, Classified
FSYK130513
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
Mar 7, 2019GETINGE US SALES LLC
Maquet XS Flat Screen Monitor Holder, SAT XS32 12 SPE, Configuration Part Number ARD2SAT00130A Product Usage: This product is designed to support one or two medical grade flat screen(s) alone or in a
Terminated
FSYNone listed
Mar 7, 2019GETINGE US SALES LLC
Maquet XS Flat Screen Monitor Holder, PWD70+DF HD R XS32 K3 SPE, Configuration Part Number ARD268400150A Product Usage: This product is designed to support one or two medical grade flat screen(s) alo
Terminated
FSYNone listed
Mar 7, 2019GETINGE US SALES LLC
Maquet XS Flat Screen Monitor Holder, PWD50+DF XS32 K3 SPE, Configuration Part Number ARD268400140A Product Usage: This product is designed to support one or two medical grade flat screen(s) alone or
Terminated
FSYNone listed
Mar 7, 2019GETINGE US SALES LLC
Maquet XS Flat Screen Monitor Holder, XS32 SPE, Configuration Part Number ARD22201040A Product Usage: This product is designed to support one or two medical grade flat screen(s) alone or in associati
Terminated
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
Apr 10, 2018GETINGE US SALES LLC
VOLISTA StandOP Surgical Light; Model numbers VLT600 SF AIM STP, VLT600 DF AIM STP, Ref. codes ARD568811901, ARD568811911 ARD568811951, ARD568811961 The device is designed to illuminate the body of a
Terminated
FSYK130513
Mar 5, 2018GETINGE US SALES LLC
ALM XTEN Surgical Light intended to provide visible illumination for the surgical field or for the examination of the patient. Part Numbers: ARD567801093, ARD567801094
Terminated
FSYK040735
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 11, 2017Windstone Medical Packaging, Inc.
Vitrectomy Pack, part number AMS4952 Product packaged in a convenient manner for use in a general clinical procedure
Terminated
FSYNone listed
Apr 11, 2017Windstone Medical Packaging, Inc.
Vitrectomy Kit, part number CMP1016(A. Product packaged in a convenient manner for use in a general clinical procedure
Terminated
FSYNone listed
Apr 11, 2017Windstone Medical Packaging, Inc.
Setup Pack, part number AMS3112(A Product packaged in a convenient manner for use in a general clinical procedure
Terminated
FSYNone listed
Apr 11, 2017Windstone Medical Packaging, Inc.
PRK Tray, part number DDS1044 Product packaged in a convenient manner for use in a general clinical procedure
Terminated
FSYNone listed
Apr 11, 2017Windstone Medical Packaging, Inc.
Plastic Pack, part numbers AMS1028, AMS1028(A, and WAL1189. Product packaged in a convenient manner for use in a general clinical procedure
Terminated
FSYNone listed
Apr 11, 2017Windstone Medical Packaging, Inc.
Ortho Basic Pack, part number AMS6459 Product packaged in a convenient manner for use in a general clinical procedure
Terminated
FSYNone listed
Apr 11, 2017Windstone Medical Packaging, Inc.
Ophthalmic Pack, Part number WAL1107(A and WAL1190 Product packaged in a convenient manner for use in a general clinical procedure
Terminated
FSYNone listed
Apr 11, 2017Windstone Medical Packaging, Inc.
Minor Operation Kit, part number AMS1530 Product packaged in a convenient manner for use in a general clinical procedure
Terminated
FSYNone listed
Apr 11, 2017Windstone Medical Packaging, Inc.
Lasik Tray, part number DDS1045-2 Product packaged in a convenient manner for use in a general clinical procedure
Terminated
FSYNone listed
Apr 11, 2017Windstone Medical Packaging, Inc.
Eye Pack, part numbers WAL1085(B and WAL1085(C\ Product packaged in a convenient manner for use in a general clinical procedure
Terminated
FSYNone listed
Apr 11, 2017Windstone Medical Packaging, Inc.
Eye Cataract Pack, part numbers AMS1359 and AMS1359-1 Product packaged in a convenient manner for use in a general clinical procedure
Terminated
FSYNone listed
Apr 11, 2017Windstone Medical Packaging, Inc.
ENT Pack, part number AMS2727 Product packaged in a convenient manner for use in a general clinical procedure
Terminated
FSYNone listed

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