FDA 510(k) Applications for Medical Device Product Code "FTD"
(Lamp, Surgical)

FDA 510(k) Number Applicant Device Name Decision Date
K041681 ATRICURE, INC. ATRICURE DISSECTOR 07/01/2004
K111020 ATRICURE, INC. ATRICURE DISSECTOR 06/09/2011
K123776 DRAGER MEDICAL GMBH POLARIS 100/200 03/08/2013
K010724 DRAGER MEDIZINTECHNIK GMBH SOLA 700,SOLA 500, SOLA 300 06/07/2001
K071180 ENGINEERED MEDICAL SOLUTIONS CO. LLC SCINTILLANT SURGICAL LIGHT, MODEL 2644-01-0001 06/20/2007
K133425 ENGINEERED MEDICAL SOLUTIONS CO. LLC. SCINTILLANT DUAL BENT TIP SURGICAL LIGHT, SCINTILLANT DUAL STRAIGHT TIP SURGICAL LIGHT 12/05/2013
K100234 HILLUSA, INC. HM-LAMP II 07/08/2010
K100884 HOWMEDICA OSTEONICS CORP. STRYKER KNIFELIGHT 06/25/2010
K130513 MAQUET SAS VOLISTA 400; VOLISTA 600 05/08/2013
K003423 ST. FRANCIS MEDICAL EQUIPMENT CO., LTD. ST. FRANCIS OPERATING THEATRE LAMP, MODELS OLH01-125 AND LC-055 02/22/2001
K013242 STERIS Corporation AMSCO HARMONY SURGICAL LIGHTING AND MEDIA SYSTEM 12/13/2001
K961122 STRYKER INSTRUMENTS STRYKER KNIFELIGHT 08/22/1996
K981717 STRYKER INSTRUMENTS STRYKER KNIFELIGHT, STRYKER ILLUMINATED RETRACTOR 06/30/1998
K053364 WALDMANN LIGHTING HALUX IRIS EXAMINATION AND SURGICAL LAMP 02/23/2006


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