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) |
|---|---|---|---|
| Apr 22, 2015 | Windstone Medical Packaging, Inc. Dr Bragg Vein Tray - RX, kit numbers 007912-5, 007912-6, 007912-7, 007912-8
convenience custom kits used for general surgery in hospital operating room Terminated |
FSY | None listed |
| Apr 22, 2015 | Windstone Medical Packaging, Inc. DND Pack, Kit number AMS3846
convenience custom kits used for general surgery in hospital operating room Terminated |
FSY | None listed |
| Apr 22, 2015 | Windstone Medical Packaging, Inc. D&C/GYN/Hysteroscopy Pack, Kit number PSS3341
convenience custom kits used for general surgery in hospital operating room Terminated |
FSY | None listed |
| Apr 22, 2015 | Windstone Medical Packaging, Inc. D&C/Cysto Pack, Kit number PSS3257, PSS3257(A, and PSS3257(B
convenience custom kits used for general surgery in hospital operating room Terminated |
FSY | None listed |
| Apr 22, 2015 | Windstone Medical Packaging, Inc. D & C Kit, Kit number CMP1466 and CMP1466(A
convenience custom kits used for general surgery in hospital operating room Terminated |
FSY | None listed |
| Apr 22, 2015 | Windstone Medical Packaging, Inc. Custom Venous Kit, TVS4024(C
convenience custom kits used for general surgery in hospital operating room Terminated |
FSY | None listed |
| Apr 22, 2015 | Windstone Medical Packaging, Inc. Custom Tray, Kit numbers: PSS1836 and PSS1836(A
convenience custom kits used for general surgery in hospital operating room Terminated |
FSY | None listed |
| Apr 22, 2015 | Windstone Medical Packaging, Inc. Custom Pack - with Introducer Kit, Kit number TVS4011NI(K and TVS4011NI(L
convenience custom kits used for general surgery in hospital operating room Terminated |
FSY | None listed |
| Apr 22, 2015 | Windstone Medical Packaging, Inc. Custom Pack, Kit numbers PSS1300, PSS1471(A, PSS1771, PSS2135(A, PSS2135(B, PSS2207, PSS2412(B, PSS2798, PSS2798(A, PSS2798(B, PSS3054, PSS3463, TVS4011NI(J, TVS4028(A, and TVS4070.
convenience custo Terminated |
FSY | None listed |
| Apr 22, 2015 | Windstone Medical Packaging, Inc. Custom Breast Augmentation Pack, Kit number PSS2455(B, PSS2455(C, PSS2455(D
convenience custom kits used for general surgery in hospital operating room Terminated |
FSY | None listed |
| Apr 22, 2015 | Windstone Medical Packaging, Inc. Custom Arterial Pack, kit number RMS1712(F
convenience custom kits used for general surgery in hospital operating room Terminated |
FSY | None listed |
| Apr 22, 2015 | Windstone Medical Packaging, Inc. Cath Pack, kit number AMS4283
convenience custom kits used for general surgery in hospital operating room Terminated |
FSY | None listed |
| Apr 22, 2015 | Windstone Medical Packaging, Inc. Cardiac Cath Pack, kit number AMS2707
convenience custom kits used for general surgery in hospital operating room Terminated |
FSY | None listed |
| Apr 22, 2015 | Windstone Medical Packaging, Inc. C-Tray Pack, Kit number PSS2707and PSS2707(A
convenience custom kits used for general surgery in hospital operating room Terminated |
FSY | None listed |
| Apr 22, 2015 | Windstone Medical Packaging, Inc. C-Section Pack, Kit number 002643-10, 002643-9, and AMS4449
convenience custom kits used for general surgery in hospital operating room Terminated |
FSY | None listed |
| Apr 22, 2015 | Windstone Medical Packaging, Inc. C-Birth Pack, Kit part number AMS2037 and AMS2037(A
convenience custom kits used for general surgery in hospital operating room Terminated |
FSY | None listed |
| Apr 22, 2015 | Windstone Medical Packaging, Inc. Brow Pack, Kit part number PSS1785(A, PSS1785(B, and PSS1785(C.
convenience custom kits used for general surgery in hospital operating room Terminated |
FSY | None listed |
| Apr 22, 2015 | Windstone Medical Packaging, Inc. Breast Pack, Kit part number AMS3238, AMS3238(A, AMS3691, AMS4419, PSS1541, PSS1784, PSS1784(A, PSS1784(B, PSS2272, and PSS2272(A.
convenience custom kits used for general surgery in hospital operati Terminated |
FSY | None listed |
| Apr 22, 2015 | Windstone Medical Packaging, Inc. Breast Augmentation Pack, Kit part number AMS1786, AMS1786(A, AMS2790, AMS3324, AMS3324(A, and PSS3430.
convenience custom kits used for general surgery in hospital operating room Terminated |
FSY | None listed |
| Apr 22, 2015 | Windstone Medical Packaging, Inc. Body Contour Pack, Kit part number PSS1749
convenience custom kits used for general surgery in hospital operating room Terminated |
FSY | None listed |
| Apr 22, 2015 | Windstone Medical Packaging, Inc. Bleph Pack, Kit part number AMS3325
convenience custom kits used for general surgery in hospital operating room Terminated |
FSY | None listed |
| Apr 22, 2015 | Windstone Medical Packaging, Inc. Bayview Breast Pack, Kit part numbers 009080-1 and 009080-2
convenience custom kits used for general surgery in hospital operating room Terminated |
FSY | None listed |
| Apr 22, 2015 | Windstone Medical Packaging, Inc. Bayview Abdominoplasty Pack, Kit part number 009079-1
convenience custom kits used for general surgery in hospital operating room Terminated |
FSY | None listed |
| Apr 22, 2015 | Windstone Medical Packaging, Inc. Basin Pack, kit number AMS2497
convenience custom kits used for general surgery in hospital operating room Terminated |
FSY | None listed |
| Apr 22, 2015 | Windstone Medical Packaging, Inc. Basic Tray, Kit part numbers AMS1199(A and PSS1559(A
convenience custom kits used for general surgery in hospital operating room Terminated |
FSY | None listed |
| Apr 22, 2015 | Windstone Medical Packaging, Inc. Basic Setup Pack, kit part number AMS1787(A
convenience custom kits used for general surgery in hospital operating room Terminated |
FSY | None listed |
| Apr 22, 2015 | Windstone Medical Packaging, Inc. Basic Pack, Kit part numbers AMS1388(A, AMS1520, AMS1868, AMS1868(A, AMS1868(B, AMS2608, AMS2608(A, AMS2728, AMS2728(A, AMS2758, AMS2758(A, AMS2972, AMS4264, AMS4309, PSS1833, and PSS1848(A.
con Terminated |
FSY | None listed |
| Apr 22, 2015 | Windstone Medical Packaging, Inc. Basic Kit, Part numbers BP1110(C and CMP1109(A.
convenience custom kits used for general surgery in hospital operating room Terminated |
FSY | None listed |
| Apr 22, 2015 | Windstone Medical Packaging, Inc. Basic Face Kit, Kit part numbers PS517A(B, PS517A(C, and PS517A(D.
convenience custom kits used for general surgery in hospital operating room Terminated |
FSY | None listed |
| Apr 22, 2015 | Windstone Medical Packaging, Inc. Basic Extended Pack, kit part number AMS4421.
convenience custom kits used for general surgery in hospital operating room Terminated |
FSY | None listed |
| Apr 22, 2015 | Windstone Medical Packaging, Inc. Augmentation Mammoplasty Tray, Kit part number AMS2234.
convenience custom kits used for general surgery in hospital operating room Terminated |
FSY | None listed |
| Apr 22, 2015 | Windstone Medical Packaging, Inc. Arthroscopy Pack, Kit numbers AMS2938, AMS3639, PSS1592(B, PSS1799, and PSS1845(A.
convenience custom kits used for general surgery in hospital operating room Terminated |
FSY | None listed |
| Apr 22, 2015 | Windstone Medical Packaging, Inc. Anterior Cervical Fusion Pack, Kit part numbers: AMS2502 and AMS2502(A
convenience custom kits used for general surgery in hospital operating room Terminated |
FSY | None listed |
| Apr 22, 2015 | Windstone Medical Packaging, Inc. Abdominoplasty Tray, there are two Kit part numbers: PSS1782 and PSS1782(A.
convenience custom kits used for general surgery in hospital operating room Terminated |
FSY | None listed |
| Apr 22, 2015 | Windstone Medical Packaging, Inc. Abdominoplasty Pack, Kit number AMS3326
convenience custom kits used for general surgery in hospital operating room Terminated |
FSY | None listed |
| Jun 23, 2014 | Steris Corporation Vertical Spring Arm for Single or Dual Monitor Mount (Harmony LL 500 and Harmony LL 700 surgical lighting systems), Steris Corporation. Model numbers YG19051 and YG19262. Terminated |
FSY | K010724 |
| Jun 6, 2014 | Maquet Medical Systems USA Maquet PowerLED 700.
Product Usage; To provide illumination to the surgical area or the patient. Terminated |
FSY | None listed |
| Dec 12, 2013 | Trumpf Medical Systems, Inc. Helion S Exam Light or H300
The device is intended to locally illuminate an examination area of the patient's body with high intensity light in a clinic or doctor's practice. Terminated |
FSY | K011693 |
| 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 |
| Dec 12, 2012 | Siemens Medical Solutions USA, Inc MAVIG PORTEGRA 2 system operated in conjuction with a Siemens AX system
Ceiling mounted surgical light Terminated |
FSY | K063333 |
| Oct 18, 2012 | Trumpf Medical Systems, Inc. Helion and Xenion surgical lights, 501/01 series KLM lights.
The surgical lights are intended to locally illuminate an operating or examination area of the patients body with a high intensity light. Terminated |
FSY | K011693 |
| Sep 5, 2012 | Trumpf Medical Systems, Inc. Acrobat 3000 (AC3000) Spring Arm as support arm for iLED operating lights, TRUMPF Medizinsysteme GmbH + Co KG 82178 Puchheim.
The TRUMPF surgical lights are intended to locally illuminate an operatin Terminated |
FSY | K061317 |
| Feb 13, 2012 | Trumpf Medical Systems, Inc. Surgical lighting systems iLED and TruLight in use with the ALC+ function.
The TRUMPF surgical lights are intended to locally illuminate an operating or examination area of the patients body with a Terminated |
FSY | K102758 |
| 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 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 |
| Apr 5, 2011 | Steris Corporation Harmony LA/LED Monitor Arm Adapter. Model Number: LB61
The Harmony LA/LED Monitor Arm Adapter is an accessory to the Harmony LA and LED Surgical Lighting System and is attached to the end of the moni Terminated |
FSY | K013242 K072072 |
| 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 |
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