FDA 510(k) Applications Submitted by Tom Tom

FDA 510(k) Number Submission Date Device Name Applicant
K161050 04/14/2016 ACTABOND Topical Skin Adhesive BERGEN MEDICAL PRODUCTS, INC.
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K202073 07/27/2020 NeedleSmart Professional (NS Pro) NeedleSmart Limited
K040424 02/18/2004 LASER ENDOSCOPIC DECOMPRESSION KIT, MODEL 1100, AND PERCUTANEOUS DISCECTOMY KIT, MODEL 1120 CLARUS MEDICAL, LLC.
K040919 04/08/2004 NUCLEOTOME PROBE SET, MODEL 21200 CLARUS MEDICAL, LLC.
K011454 05/11/2001 SPINE SCOPE, MODEL 2180 CLARUS MEDICAL, LLC.
K021848 06/05/2002 CLARUS STRAIGHT FIRING LASER FIBER; CLARUS SIDE FIRING LASER FIBER; MODELS 1150, 1160 CLARUS MEDICAL, LLC.
K022610 08/06/2002 CLARUS STRAIGHT FIRING LASER FIBER, MODEL 1150, CLARUS SIDE FIRING LASER FIBER, MODEL 1160 CLARUS MEDICAL, LLC.
K171124 04/17/2017 Nihon Kohden Wireless Input Unit WEE-1200 Nihon Kohden Corporation
K151080 04/22/2015 Nihon Kohden CSM 1901 Bedside Monitor Nihon Kohden
K152305 08/14/2015 Nihon Kohden Afib Detection Program QP-039P NIHON KOHDEN CORPORATION
K163459 12/09/2016 Nihon Kohden Vital Sign Telemeter Nihon Kohden Corporation
K183529 12/19/2018 AE-120A EEG Head Set Nihon Kohden Corporation
K153707 12/23/2015 Nihon Kohden Vital Sign Telemeter NIHON KOHDEN CORPORATION
K163644 12/23/2016 Nihon Kohden QP-160AK EEG Trend Program Nihon Kohden Corporation
K163282 11/21/2016 Apex Dental Sensors Masterlink LLC
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K173823 12/18/2017 Amrad Medical AAU Digital Radiography System; Amrad Medical AAU Plus Digital Radiography System; Amrad Medical DFMT Digital Radiography System; Amrad Medical FMT Digital Radiography System Summit Industries LLC
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K213597 11/12/2021 MultiCut Solo Asclepion Laser Technologies GmbH
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K131785 06/18/2013 PAGODA PEDICLE SCREW SYSTEM ORTHO DEVELOPMENT CORP.
K111936 07/08/2011 ORTHO DEVLOPMENT CERAMIC FEMORAL HEAD ORTHO DEVELOPMENT
K111965 07/11/2011 VUSION(R) OS ORTHO DEVELOPMENT
K122588 08/24/2012 VUSION CS PLUS ORTHO DEVELOPMENT CORP.
K132697 08/29/2013 ENCOMPASS 10/12 HIP STEM ORTHO DEVELOPMENT CORP.
K123457 11/08/2012 BALANCED KNEE SYSTEM HIGH FLEX PS ORTHO DEVELOPMENT CORP.
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K012368 07/26/2001 AEROPEP TRUDELL MEDICAL INTL.
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K073271 11/21/2007 ORTHOGON AGFA HEALTHCARE CORPORATION
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