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 Castle Co..

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 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 Dec 01, 2004
OUTPATIENT III MINOR SURGERY LIGHT
K042395
Burton Medical Products Corp.
General & Plastic Surgery · 90d
Cleared Nov 30, 2004
DUAL LED LITE ENGINE WITH ILLUMINATION LED CABLE COUPLED TO A LED LITE HEAD
K042382
Med-General Technologies, LLC
General & Plastic Surgery · 90d
Cleared Aug 12, 2003
STRYKER VISUM SURGICAL LIGHTING SYSTEM
K031068
Stryker Endoscopy
General & Plastic Surgery · 130d
Cleared Mar 21, 2003
CHROMOPHARE X 65
K024132
Berchtold Holding GmbH
General & Plastic Surgery · 95d
Cleared Nov 13, 2002
STELLAR SERIES SURGICAL LIGHTS WITH HERMES
K021585
Skytron, Div. the Kmw Group, Inc.
General & Plastic Surgery · 183d
Cleared Nov 08, 2000
STELLAR
K002463
Skytron, Div. the Kmw Group, Inc.
General & Plastic Surgery · 90d
Cleared Nov 08, 1999
CASTLE SURGICAL LIGHT, MODEL 3000
K993242
Getinge/Castle, Inc.
General & Plastic Surgery · 42d
Cleared Sep 08, 1999
MILLENNIUM GOLD
K992090
Skytron, Div. the Kmw Group, Inc.
General & Plastic Surgery · 79d

About Product Code FSY - Regulatory Context