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
74 devices
25–48 of 74
Cleared Nov 21, 2006
M3
K063333
Mavig GmbH
General & Plastic Surgery · 15d
Cleared Jun 22, 2006
ILED
K061317
Trumpf Kreuzer Medizin Systeme GmbH + Co.Kg
General & Plastic Surgery · 42d
Cleared Apr 07, 2006
VISUM LED SURGICAL LIGHTING SYSTEM
K060802
Stryker Communications Corp.
General & Plastic Surgery · 14d
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 May 21, 2004
ALM X'TEN (X10) SURGICAL LIGHT SYSTEM
K040735
Alm S.A.
General & Plastic Surgery · 60d
Cleared Jan 21, 2004
MODIFICATION TO PRISMALIX SURGICAL LIGHT
K040015
Alm S.A.
General & Plastic Surgery · 16d
Cleared Aug 12, 2003
STRYKER VISUM SURGICAL LIGHTING SYSTEM
K031068
Stryker Endoscopy
General & Plastic Surgery · 130d
Cleared Jul 25, 2003
CONMED INTEGRATED SYSTEMS NURSES ASSISTANT
K031979
Conmed Integrated Systems (Cmis)
General & Plastic Surgery · 29d
Cleared Apr 23, 2003
AXCEL SURGICAL LIGHT
K030906
Alm
General & Plastic Surgery · 30d
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 Jun 13, 2001
TRUMPF SURGICAL LIGHTS, MODELS 301,501,701,1001
K011693
Trumpf Medical Systems, Inc.
General & Plastic Surgery · 13d
Cleared May 30, 2001
VAL LUX 600 SURGICAL LIGHT (PLUS AND RS), MODEL ML600/S: SINGLE LIGHT HEAD, ML600/SS: SINGLE LIGHT HEAD, ML600/1D): DOUB
K010716
Valmed Corp.
General & Plastic Surgery · 82d
Cleared Nov 08, 2000
STELLAR
K002463
Skytron, Div. the Kmw Group, Inc.
General & Plastic Surgery · 90d
Cleared May 25, 2000
VISIONARY 2000
K000639
Burton Medical Products Corp.
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
Cleared Jul 20, 1999
CHROMOPHARE D 530 LDR SURGICAL LIGHT
K990656
Berchtold Holding GmbH
General & Plastic Surgery · 141d
Cleared May 27, 1999
CHROMOPHARE D500, D530, D650
K991527
Berchtold Holding GmbH
General & Plastic Surgery · 24d
Cleared Mar 29, 1999
DRAGER SOLA SERIES, MODELS 1000/700/500/300
K984611
Drager Medizintechnik GmbH
General & Plastic Surgery · 90d
Cleared Sep 22, 1998
ALM PRISMALIX (PRX) SURGICAL LIGHT
K982063
Alm Surgical Equipment, Inc.
General & Plastic Surgery · 102d
Cleared Apr 29, 1998
BRIGHTSTAR
K981081
Hill-Rom, Inc.
General & Plastic Surgery · 36d
Cleared Mar 03, 1998
GETINGE/CASTLE OPTIVIEW SERIES SURGICAL LIGHT
K974084
Getinge/Castle, Inc.
General & Plastic Surgery · 125d