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 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
Cleared Feb 20, 1998
CHROMOPHARE D 500, CHROMOPHARE D 530
K974433
Berchtold Holding GmbH
General & Plastic Surgery · 88d
Cleared Oct 24, 1997
HANAULUX BLUE 75 AND HANAULUX BLUE 120
K973466
Heraeus Med GmbH
General & Plastic Surgery · 70d
Cleared Jul 14, 1997
CHROMOPHARE
K965130
Berchtold Holding GmbH
General & Plastic Surgery · 203d
Cleared Nov 13, 1996
GENIE' SINGLE CEILING AND DOUBLE CEILING
K963682
Burton Medical Products Corp.
General & Plastic Surgery · 71d
Cleared Aug 22, 1996
GENIE
K961843
Burton Medical Products Corp.
General & Plastic Surgery · 101d
Cleared Feb 01, 1996
HANAULUX BLUE 30 & 80
K954169
Heraeus Med GmbH
General & Plastic Surgery · 149d
Cleared Oct 19, 1994
CHROMOPHARE
K944855
Berchtold Holding GmbH
General & Plastic Surgery · 19d
Cleared Oct 17, 1994
AMSCO SQ240 SURGICAL LIGHT
K943288
American Sterilizer Co.
General & Plastic Surgery · 101d
Cleared Feb 20, 1992
SKYTRON INFINITY SERIES SURGICAL LIGHTS
K915285
Skytron, Div. the Kmw Group, Inc.
General & Plastic Surgery · 87d
Cleared Nov 13, 1991
MDT/CASTLE 2000 SURGICAL LIGHTS
K914076
Mdt Corp., Inc.
General & Plastic Surgery · 63d
Cleared Sep 10, 1990
SURGICAL LIGHTING-CENTRA 450
K902864
Sds Dental, Inc.
General & Plastic Surgery · 73d
Cleared Mar 19, 1990
SKYTRON UNIVERSE SERIES SURGICAL LIGHTS
K900211
Skytron, Div. the Kmw Group, Inc.
General & Plastic Surgery · 61d
Cleared Jan 03, 1990
AMSCO QUANTUM LIGHT
K896674
American Sterilizer Co.
General & Plastic Surgery · 37d
Cleared Oct 23, 1987
SMITH & NEPHEW DAYLIGHTER(TM)
K873786
Smith & Nephew, Inc.
General & Plastic Surgery · 36d
Cleared Jan 24, 1986
AMSCO POLARIS SL
K854922
Amsco Co.
General & Plastic Surgery · 45d
Cleared Apr 15, 1982
CASTLE(R) 2510 & 2610 MINOR SURG. LIGHT
K820681
Sybron Corp.
General & Plastic Surgery · 35d
Cleared Dec 12, 1978
9100 DAYSTAR AND 9110 ORBITER PACKAGE
K781887
Castle Co.
General & Plastic Surgery · 35d
Cleared Apr 27, 1978
DAYSTAR SELECTRA & SELECTRA/ORBITER
K780666
Castle Co.
General & Plastic Surgery · 48d