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

Company510(k)sRecalls
Windstone Medical Packaging, Inc.0292
Resource Optimization & Innovation Llc077
Stryker Communications218
Covidien LLC014
Trumpf Medical Systems, Inc.111
Getinge Usa Sales Inc010
Berchtold Holding GmbH90
STERIS Corporation17
DKK Dai-Ichi Shomei Co., Ltd.06
GETINGE US SALES LLC06
Decided510(k)Device and applicantCode
Oct 29, 2014K142984Leo Minor
Sunnex, Inc.
FSY
Sep 30, 2014K142076CLAVEGUARD FREEDOM SURGICAL LIGHT
Dickson & Dickson Healthcare (Us), Inc.
FSY
Aug 7, 2014K140812MI-750 PROCEDURAL/MINOR SURGICAL LIGHT
Medical Illumination International, Inc.
FSY
Jun 30, 2014K132551ZF 720
Umbel Corporation
FSY
Jun 9, 2014K140930VIDA LED SURGICAL LIGHTING SYSTEM, V SERIES
Convida Healthcare & Systems Corporation, TW
FSY
Apr 3, 2014K140461MACH LED 2MC
Dr. Mach GmbH & Co. KG, DE
FSY
Apr 3, 2014K140460MACH LED 2SC
Dr. Mach GmbH & Co. KG, DE
FSY
Dec 30, 2013K132747VISUM BLADE LED SURGICAL LIGHTING SYSTEM
Stryker Communications
FSY
Nov 5, 2013K132307VIDA LED SURGICAL LIGHTING SYSTEM
Convida Healthcare & Systems Corporation, TW
FSY
Oct 30, 2013K131893AMICO CE SERIES SURGICAL LIGHTS, MIRA LED SERIES MINOR SURGICAL LIGHTS
Ajw Technology Consultants, Inc.
FSY
Dec 18, 2012K122875ORICARE L2700
Oricare, Inc.
FSY
Feb 16, 2012K120392CHROMOPHARE F 628 AND F 528
Berchtold GmbH & Co. KG, DE
FSY
Oct 26, 2010K102758TRULIGHT 5520 AND TRULIGHT 5320
Trumpf Kreuzer Medizin Systeme GmbH + Co.Kg
FSY
Sep 30, 2010K101537AIM 200, MAJOR SURGICAL LIGHT
Burton Medical Products Corp.
FSY
Jul 20, 2010K100702STARTROL LED LIGHTING SYSTEMS (X=# OF PODS, Y=# OF LEDS, N=TO MOUNTING STYLE) MODEL X X Y -N-S-W. X=NUMBER OF LIGHT PODS
Huot Instruments, LLC
FSY
Apr 1, 2010K093010MACH LED MC
Dr. Mach GmbH & Co. KG, DE
FSY
Apr 1, 2010K093009MACH LED SC
Dr. Mach GmbH & Co. KG, DE
FSY
Feb 23, 2009K090378CHROMOPHARE E 668
Berchtold GmbH & Co. KG
FSY
Jan 28, 2009K083323NUVO VERDE LED LIGHTING SYSTEM
Nuvo, Inc.
FSY
Oct 30, 2008K083066CHROMOPHARE E 778 AND E 558
Berchtold Holding GmbH, DE
FSY
Apr 10, 2008K080857CHROMOPHARE E-SERIES
Berchtold Holding GmbH, DE
FSY
Oct 5, 2007K072072HARMONY LED-1 SURGICAL LIGHTING SYSTEM
STERIS Corporation
FSY
Jul 6, 2007K071698AURORA LED SERIES SURGICAL LIGHTS
Skytron, Div. the Kmw Group, Inc.
FSY
Mar 16, 2007K070442POWERLED SURGICAL LIGHT SYSTEM
Maquet S.A.
FSY
Nov 21, 2006K063333M3
Mavig GmbH, DE
FSY
Jun 22, 2006K061317ILED
Trumpf Kreuzer Medizin Systeme GmbH + Co.Kg, DE
FSY
Apr 7, 2006K060802VISUM LED SURGICAL LIGHTING SYSTEM
Stryker Communications Corp.
FSY
Dec 1, 2004K042395OUTPATIENT III MINOR SURGERY LIGHT
Burton Medical Products Corp.
FSY
Nov 30, 2004K042382DUAL LED LITE ENGINE WITH ILLUMINATION LED CABLE COUPLED TO A LED LITE HEAD
Med-General Technologies, LLC
FSY
May 21, 2004K040735ALM X'TEN (X10) SURGICAL LIGHT SYSTEM
Alm S.A.
FSY
Jan 21, 2004K040015MODIFICATION TO PRISMALIX SURGICAL LIGHT
Alm S.A.
FSY
Aug 12, 2003K031068STRYKER VISUM SURGICAL LIGHTING SYSTEM
Stryker Endoscopy
FSY
Jul 25, 2003K031979CONMED INTEGRATED SYSTEMS NURSES ASSISTANT
Conmed Integrated Systems (Cmis)
FSY
Apr 23, 2003K030906AXCEL SURGICAL LIGHT
Alm
FSY
Mar 21, 2003K024132CHROMOPHARE X 65
Berchtold Holding GmbH, DE
FSY
Nov 13, 2002K021585STELLAR SERIES SURGICAL LIGHTS WITH HERMES
Skytron, Div. the Kmw Group, Inc.
FSY
Jun 13, 2001K011693TRUMPF SURGICAL LIGHTS, MODELS 301,501,701,1001
Trumpf Medical Systems, Inc.
FSY
May 30, 2001K010716VAL LUX 600 SURGICAL LIGHT (PLUS AND RS), MODEL ML600/S: SINGLE LIGHT HEAD, ML600/SS: SINGLE LIGHT HEAD, ML600/1D): DOUB
Valmed Corp.
FSY
Nov 8, 2000K002463STELLAR
Skytron, Div. the Kmw Group, Inc.
FSY
May 25, 2000K000639VISIONARY 2000
Burton Medical Products Corp.
FSY
Nov 8, 1999K993242CASTLE SURGICAL LIGHT, MODEL 3000
Getinge/Castle, Inc.
FSY
Sep 8, 1999K992090MILLENNIUM GOLD
Skytron, Div. the Kmw Group, Inc.
FSY
Jul 20, 1999K990656CHROMOPHARE D 530 LDR SURGICAL LIGHT
Berchtold Holding GmbH, DE
FSY
May 27, 1999K991527CHROMOPHARE D500, D530, D650
Berchtold Holding GmbH, DE
FSY
Mar 29, 1999K984611DRAGER SOLA SERIES, MODELS 1000/700/500/300
Drager Medizintechnik GmbH, DE
FSY
Sep 22, 1998K982063ALM PRISMALIX (PRX) SURGICAL LIGHT
Alm Surgical Equipment, Inc.
FSY
Apr 29, 1998K981081BRIGHTSTAR
Hill-Rom, Inc.
FSY
Mar 3, 1998K974084GETINGE/CASTLE OPTIVIEW SERIES SURGICAL LIGHT
Getinge/Castle, Inc.
FSY
Feb 20, 1998K974433CHROMOPHARE D 500, CHROMOPHARE D 530
Berchtold Holding GmbH, DE
FSY
Oct 24, 1997K973466HANAULUX BLUE 75 AND HANAULUX BLUE 120
Heraeus Med GmbH, DE
FSY

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