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)
Top companies in FSY
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Sep 18, 2026 | Maquet SAS PowerLED 300 Concealed Lighting System (PWD30+SF W K3 SPRING ARM A2 FC3 50-100nm)
Model Numbers: 1. ARD568474114A, 2. ARD567501286; Open, Classified |
FSY | K070442 |
| Jun 15, 2026 | Steris Corporation ALYON Surgical Lighting System Open, Classified |
FSY | None listed |
| Jun 15, 2026 | Steris Corporation HarmonyAIR A-Series Surgical Lighting System Open, Classified |
FSY | None listed |
| Jun 15, 2026 | Steris Corporation HarmonyAIR A-Series Surgical Lighting System Open, Classified |
FSY | None listed |
| 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 |
| Jul 25, 2025 | Steris Corporation Dual Flat Panel Monitor (DFPM) accessories for HarmonyAIR E-Series Surgical Lighting Systems Open, Classified |
FSY | None listed |
| Jul 25, 2025 | Steris Corporation Dual Flat Panel Monitor (DFPM) accessories for HarmonyAIR A-Series Surgical Lighting Systems Open, Classified |
FSY | None listed |
| Aug 14, 2024 | DKK 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 |
FSY | K071698 |
| Aug 14, 2024 | DKK 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 |
FSY | K071698 |
| Aug 14, 2024 | DKK 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 |
FSY | K071698 |
| Aug 14, 2024 | DKK 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 |
FSY | K071698 |
| Apr 9, 2024 | Stryker Communications Chromophare Surgical Light System , REF CH00000001 Open, Classified |
FSY | K120392 |
| Jan 19, 2024 | Getinge 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 |
FSY | None listed |
| Jan 19, 2024 | Getinge 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 |
FSY | K954169 K970886 |
| Jan 19, 2024 | Getinge 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 |
FSY | None listed |
| Jan 19, 2024 | Getinge 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 |
FSY | K932451 |
| Jan 19, 2024 | Getinge 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 |
FSY | K982063 |
| Jan 19, 2024 | Getinge 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 |
FSY | K040735 |
| Jan 19, 2024 | Getinge Usa Sales Inc Maquet Hanaulux HLX3000 OR Light Systems, Model Numbers and Catalog Numbers H3 BC - HM567811111C Open, Classified |
FSY | None listed |
| Jan 19, 2024 | Getinge 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 |
FSY | K030906 |
| Jan 19, 2024 | Getinge 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 |
FSY | K070442 |
| Oct 6, 2023 | DKK 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 |
FSY | None listed |
| Oct 6, 2023 | DKK 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 |
FSY | None listed |
| Jun 30, 2022 | Getinge 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 |
FSY | K130513 |
| 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 |
| Mar 7, 2019 | GETINGE 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 |
FSY | None listed |
| Mar 7, 2019 | GETINGE 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 |
FSY | None listed |
| Mar 7, 2019 | GETINGE 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 |
FSY | None listed |
| Mar 7, 2019 | GETINGE 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 |
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 |
| Apr 10, 2018 | GETINGE 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 |
FSY | K130513 |
| Mar 5, 2018 | GETINGE 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 |
FSY | K040735 |
| 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 11, 2017 | Windstone Medical Packaging, Inc. Vitrectomy Pack, part number AMS4952
Product packaged in a convenient manner for use in a general clinical procedure Terminated |
FSY | None listed |
| Apr 11, 2017 | Windstone Medical Packaging, Inc. Vitrectomy Kit, part number CMP1016(A.
Product packaged in a convenient manner for use in a general clinical procedure Terminated |
FSY | None listed |
| Apr 11, 2017 | Windstone Medical Packaging, Inc. Setup Pack, part number AMS3112(A
Product packaged in a convenient manner for use in a general clinical procedure Terminated |
FSY | None listed |
| Apr 11, 2017 | Windstone Medical Packaging, Inc. PRK Tray, part number DDS1044
Product packaged in a convenient manner for use in a general clinical procedure Terminated |
FSY | None listed |
| Apr 11, 2017 | Windstone 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 |
FSY | None listed |
| Apr 11, 2017 | Windstone Medical Packaging, Inc. Ortho Basic Pack, part number AMS6459
Product packaged in a convenient manner for use in a general clinical procedure Terminated |
FSY | None listed |
| Apr 11, 2017 | Windstone 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 |
FSY | None listed |
| Apr 11, 2017 | Windstone Medical Packaging, Inc. Minor Operation Kit, part number AMS1530
Product packaged in a convenient manner for use in a general clinical procedure Terminated |
FSY | None listed |
| Apr 11, 2017 | Windstone Medical Packaging, Inc. Lasik Tray, part number DDS1045-2
Product packaged in a convenient manner for use in a general clinical procedure Terminated |
FSY | None listed |
| Apr 11, 2017 | Windstone 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 |
FSY | None listed |
| Apr 11, 2017 | Windstone 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 |
FSY | None listed |
| Apr 11, 2017 | Windstone Medical Packaging, Inc. ENT Pack, part number AMS2727
Product packaged in a convenient manner for use in a general clinical procedure Terminated |
FSY | None listed |
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