FSY · Class II · 21 CFR 878.4580

FDA Product Code FSY: Light, Surgical, Ceiling Mounted

Leading manufacturers include Berchtold Holding GmbH, Skytron, Div. the Kmw Group, Inc. and Burton Medical Products Corp..

74
Total
74
Cleared
73d
Avg days
1977
Since

FDA 510(k) Cleared Light, Surgical, Ceiling Mounted Devices (Product Code FSY)

74 devices
1–24 of 74
Cleared Oct 29, 2014
Leo Minor
K142984
Sunnex, Inc.
General & Plastic Surgery · 13d
Cleared Sep 30, 2014
CLAVEGUARD FREEDOM SURGICAL LIGHT
K142076
Dickson & Dickson Healthcare (Us), Inc.
General & Plastic Surgery · 61d
Cleared Aug 07, 2014
MI-750 PROCEDURAL/MINOR SURGICAL LIGHT
K140812
Medical Illumination International, Inc.
General & Plastic Surgery · 128d
Cleared Jun 30, 2014
ZF 720
K132551
Umbel Corporation
General & Plastic Surgery · 320d
Cleared Jun 09, 2014
VIDA LED SURGICAL LIGHTING SYSTEM, V SERIES
K140930
Convida Healthcare & Systems Corporation
General & Plastic Surgery · 59d
Cleared Apr 03, 2014
MACH LED 2SC
K140460
Dr. Mach GmbH & Co. KG
General & Plastic Surgery · 38d
Cleared Apr 03, 2014
MACH LED 2MC
K140461
Dr. Mach GmbH & Co. KG
General & Plastic Surgery · 38d
Cleared Dec 30, 2013
VISUM BLADE LED SURGICAL LIGHTING SYSTEM
K132747
Stryker Communications
General & Plastic Surgery · 118d
Cleared Nov 05, 2013
VIDA LED SURGICAL LIGHTING SYSTEM
K132307
Convida Healthcare & Systems Corporation
General & Plastic Surgery · 104d
Cleared Oct 30, 2013
AMICO CE SERIES SURGICAL LIGHTS, MIRA LED SERIES MINOR SURGICAL LIGHTS
K131893
Ajw Technology Consultants, Inc.
General & Plastic Surgery · 127d
Cleared Dec 18, 2012
ORICARE L2700
K122875
Oricare, Inc.
General & Plastic Surgery · 90d
Cleared Feb 16, 2012
CHROMOPHARE F 628 AND F 528
K120392
Berchtold GmbH & Co. KG
General & Plastic Surgery · 8d
Cleared Oct 26, 2010
TRULIGHT 5520 AND TRULIGHT 5320
K102758
Trumpf Kreuzer Medizin Systeme GmbH + Co.Kg
General & Plastic Surgery · 33d
Cleared Sep 30, 2010
AIM 200, MAJOR SURGICAL LIGHT
K101537
Burton Medical Products Corp.
General & Plastic Surgery · 119d
Cleared Jul 20, 2010
STARTROL 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
K100702
Huot Instruments, LLC
General & Plastic Surgery · 130d
Cleared Apr 01, 2010
MACH LED SC
K093009
Dr. Mach GmbH & Co. KG
General & Plastic Surgery · 184d
Cleared Apr 01, 2010
MACH LED MC
K093010
Dr. Mach GmbH & Co. KG
General & Plastic Surgery · 184d
Cleared Feb 23, 2009
CHROMOPHARE E 668
K090378
Berchtold GmbH & Co. KG
General & Plastic Surgery · 6d
Cleared Jan 28, 2009
NUVO VERDE LED LIGHTING SYSTEM
K083323
Nuvo, Inc.
General & Plastic Surgery · 77d
Cleared Oct 30, 2008
CHROMOPHARE E 778 AND E 558
K083066
Berchtold Holding GmbH
General & Plastic Surgery · 15d
Cleared Apr 10, 2008
CHROMOPHARE E-SERIES
K080857
Berchtold Holding GmbH
General & Plastic Surgery · 14d
Cleared Oct 05, 2007
HARMONY LED-1 SURGICAL LIGHTING SYSTEM
K072072
STERIS Corporation
General & Plastic Surgery · 67d
Cleared Jul 06, 2007
AURORA LED SERIES SURGICAL LIGHTS
K071698
Skytron, Div. the Kmw Group, Inc.
General & Plastic Surgery · 15d
Cleared Mar 16, 2007
POWERLED SURGICAL LIGHT SYSTEM
K070442
Maquet S.A.
General & Plastic Surgery · 29d

About Product Code FSY - Regulatory Context