FTD · Class II · 21 CFR 878.4580

FDA Product Code FTD: Lamp, Surgical

Leading manufacturers include Stryker Instruments, Fiber Optics Engineering, Inc. and Burton Medical Products Corp..

29
Total
29
Cleared
70d
Avg days
1977
Since

FDA 510(k) Cleared Lamp, Surgical Devices (Product Code FTD)

29 devices
1–24 of 29
Cleared Dec 05, 2013
SCINTILLANT DUAL BENT TIP SURGICAL LIGHT, SCINTILLANT DUAL STRAIGHT TIP SURGICAL LIGHT
K133425
Engineered Medical Solutions Co., LLC
General & Plastic Surgery · 27d
Cleared May 08, 2013
VOLISTA 400
K130513
Maquet S.A.S.
General & Plastic Surgery · 70d
Cleared Mar 08, 2013
POLARIS 100/200
K123776
Drager Medical GmbH
General & Plastic Surgery · 88d
Cleared Jun 09, 2011
ATRICURE DISSECTOR
K111020
AtriCure, Inc.
General & Plastic Surgery · 58d
Cleared Jul 08, 2010
HM-LAMP II
K100234
Hillusa, Inc.
General & Plastic Surgery · 163d
Cleared Jun 25, 2010
STRYKER KNIFELIGHT
K100884
Howmedica Osteonics Corp.
General & Plastic Surgery · 87d
Cleared Jun 20, 2007
SCINTILLANT SURGICAL LIGHT, MODEL 2644-01-0001
K071180
Engineered Medical Solutions Co., LLC
General & Plastic Surgery · 51d
Cleared Feb 23, 2006
HALUX IRIS EXAMINATION AND SURGICAL LAMP
K053364
Waldmann Lighting
General & Plastic Surgery · 83d
Cleared Jul 01, 2004
ATRICURE DISSECTOR
K041681
AtriCure, Inc.
General & Plastic Surgery · 10d
Cleared Dec 13, 2001
AMSCO HARMONY SURGICAL LIGHTING AND MEDIA SYSTEM
K013242
STERIS Corporation
General & Plastic Surgery · 76d
Cleared Jun 07, 2001
SOLA 700,SOLA 500, SOLA 300
K010724
Drager Medizintechnik GmbH
General & Plastic Surgery · 87d
Cleared Feb 22, 2001
ST. FRANCIS OPERATING THEATRE LAMP, MODELS OLH01-125 AND LC-055
K003423
St. Francis Medical Equipment Co., Ltd.
General & Plastic Surgery · 111d
Cleared Jun 30, 1998
STRYKER KNIFELIGHT, STRYKER ILLUMINATED RETRACTOR
K981717
Stryker Instruments
General & Plastic Surgery · 46d
Cleared Aug 22, 1996
STRYKER KNIFELIGHT
K961122
Stryker Instruments
General & Plastic Surgery · 154d
Cleared Oct 18, 1995
XE-LITE
K954263
Ophthalmic Technologies, Inc.
General & Plastic Surgery · 36d
Cleared Jun 23, 1994
GENESIS
K942553
Burton Medical Products Corp.
General & Plastic Surgery · 23d
Cleared Feb 22, 1994
MEDLINE'S EXAMIN, OPERATING ROOM/SURG LIGHTS/LAMPS
K931675
Medline Industries, Inc.
General & Plastic Surgery · 322d
Cleared Nov 12, 1993
HANAULUX 2005 SURGICAL LIGHT
K932451
Heraeus Instruments GmbH
General & Plastic Surgery · 176d
Cleared Jun 25, 1993
MI-15 EXAM SURGICAL LIGHT
K930897
Medical Illumination, Inc.
General & Plastic Surgery · 123d
Cleared Oct 13, 1989
HANAULUX(R) 2000
K895715
W.C. Heraeus GmbH
General & Plastic Surgery · 18d
Cleared Jul 18, 1988
ALM SURGICAL LAMPS
K882613
Alm Surgical Equipment, Inc.
General & Plastic Surgery · 24d
Cleared Jan 24, 1986
PL EXAM LIGHT
K860088
Burton Medical Products Corp.
General & Plastic Surgery · 14d
Cleared Apr 24, 1984
MINOR SURGICAL LIGHT MODEL 180
K841360
American Sterilizer Co.
General & Plastic Surgery · 22d
Cleared Dec 03, 1982
SURGICAL LIGHT
K823360
Amsco Co.
General & Plastic Surgery · 28d

About Product Code FTD - Regulatory Context