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
49–72 of 74
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 Oct 09, 1992
CHROMOPHARE
K922836
Berchtold Holding GmbH
General & Plastic Surgery · 119d
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 Jan 16, 1991
SHAMPAINE 1000 SERIES ANGENIEUX AX-14 DUO,AX-4
K904965
Smith & Nephew Equipment Group
General & Plastic Surgery · 72d
Cleared Sep 10, 1990
SURGICAL LIGHTING-CENTRA 450
K902864
Sds Dental, Inc.
General & Plastic Surgery · 73d
Cleared May 24, 1990
CHICK III SURGICAL LIGHTING SYSTEM
K901830
Chick Medical Products
General & Plastic Surgery · 30d
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 Jun 15, 1989
KINETIC MODEL 700
K892808
Kinetic Biomedical Services, Inc.
General & Plastic Surgery · 59d
Cleared Apr 19, 1989
KINETIC MODEL 500
K891756
Kinetic Biomedical Services, Inc.
General & Plastic Surgery · 27d
Cleared Apr 19, 1989
KINETIC MODEL 1000
K891757
Kinetic Biomedical Services, Inc.
General & Plastic Surgery · 27d
Cleared Oct 23, 1987
SMITH & NEPHEW DAYLIGHTER(TM)
K873786
Smith & Nephew, Inc.
General & Plastic Surgery · 36d
Cleared Mar 28, 1986
CHICK SURIGICAL LIGHT
K860739
Professional Medical Products, Inc.
General & Plastic Surgery · 29d
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