FDA 510(k) Applications Submitted by M ARIE

FDA 510(k) Number Submission Date Device Name Applicant
K950018 01/03/1995 CAMBRIDGE HEART CH 2000 STRESS TEST SYSTEM CAMBRIDGE HEART, INC.
K142132 08/04/2014 POOL NORM Diagnostics Stago S.A.S.
K101983 07/14/2010 CRITICAL CARE ASSESSMENT CRITICAL PATIENT CARE, INC.
K220070 01/10/2022 MyDay (stenfilcon A) Soft (Hydrophilic) Daily Disposable Contact Lens, Avaira Vitality (fanfilcon A) Soft (Hydrophilic) Contact Lens CooperVision, Inc.
K190965 04/12/2019 MyDay CooperVision, Inc.
K191763 07/01/2019 MyDay (Stenfilcon A) ASPHERE, MyDay (Stenfilcon A) TORIC, MyDay (Stenfilcon A) MULTIFOCAL, MyDay (Stenfilcon A) MULTIFOCAL TORIC CooperVision, Inc.
K181920 07/18/2018 Clariti 1 day (somofilcon A) Soft (Hydrophilic) Daily Disposable Contact Lens with UV Blocker CooperVision, Inc.
K202756 09/21/2020 Clariti 1 Day (somofilcon A), Clariti 1 Day Toric (somofilcon A), Clariti 1 Day Multifocal (somofilcon A), Clariti 1 Day Multifocal Toric (somofilcon A) CooperVision, Inc.
K220485 02/17/2022 Wireless Hand Control, EG1A (WIRELESS-HC), Receiver for Wireless Hand Control, EG1A (RECEIVER-HC) The Anspach Effort, Inc.
K220506 02/22/2022 SkinPen Precision System Crown Aesthetics
K202243 08/10/2020 SkinPen Precision System Crown Aesthetics
K212423 08/04/2021 EndoDrill« Model X Bibbinstruments AB
K160551 02/29/2016 VALO Grand ULTRADENT PRODUCTS, INC.
K152779 09/25/2015 Avex CX2 Opal Orthodontics by Ultradent Products
K000379 02/07/2000 MODOFICATION TO AFFFINITY 38 MICRO ARTERIAL BLOOD FILTER WITH CARMEDA BIOACTIVE SURFACE, MODELS CB351/CB352 MEDTRONIC VASCULAR
K010737 03/12/2001 SELECT CAP ARTERIAL CANNULA WITH PRESSURE MONITORING LINE, MODEL 78818,78820,78822,78824,78918,78920,78922,78924 MEDTRONIC CARDIAC SURGICAL PRODUCTS
K001138 04/10/2000 AFFINITY 20 MICRON ARTERIAL BLOOD FILTER WITH CARMEDA BIOACTIVE SURFACE, MODELS CB353/CB354 MEDTRONIC VASCULAR
K011864 06/14/2001 TRILLIUM MYOTHERM XP CARDIOPLEGIA DELIVERY SYSTEM, MODELS 41, 41-B MEDTRONIC VASCULAR
K012538 08/07/2001 TUBING AND CONNECTORS WITH TRILLIUM BIOPASSIVE SURFACE MEDTRONIC VASCULAR
K012743 08/16/2001 TRILLIUM TRI-OPTIC MEASUREMENT CELL, MODEL TMC 25T, TMC38 T, TMC 50T MEDTRONIC PERFUSION SYSTEMS
K012747 08/16/2001 TRILLIUM BIO DISPOSABLE BLOOD FLOW PROBE (MODELS DP38T & FP38P) MEDTRONIC PERFUSION SYSTEMS
K013084 09/14/2001 AFFINITY 38 MICON ARTERIAL FILTER WITH TRILLIUM BIOPASSIVE SURFACE, MODEL 351T MEDTRONIC PERFUSION SYSTEMS
K003724 12/04/2000 CBMYOTHERM XP CARDIOPLEGIA DELIVERY SYSTEM WITH CARMEDA BIOACTIVE SURFACE, MODELS CB41 AND CB41-B MEDTRONIC VASCULAR
K994208 12/14/1999 AFFINITY 20 MICRON ARTERIAL BLOOD FILTER, MODEL 353/354 MEDTRONIC PERFUSION SYSTEMS
K043373 12/08/2004 DOLOTENS DENTAL TM 1 NEUROMUSCULAR TECHNOLOGIES, INC.
K170928 03/29/2017 CADence System AUM Cardiovascular, Inc.
K090844 03/27/2009 BUPRENORPHINE ENZYME IMMUNOASSAY WITH NORBUPRENORPHINE CALIBRATORS AND CONTROLS Lin-Zhi International, Inc.
K081008 04/10/2008 BUPRENORPHINE ENZYME IMMUNOASSAY, CALIBRATORS AND CONTROLS FOR BECKMAN COULTER SYNCHRON SYSTEMS Lin-Zhi International, Inc.
K050988 04/19/2005 OPIATE ORAL FLUID HOMOGENEOUS ENZYME IMMUNOASSAY, CALIBRATORS AND CONTROLS Lin-Zhi International, Inc.
K062242 08/02/2006 METHAMPHETAMINE ORAL FLUID HOMOGENEOUS ENZYME IMMUNOASSAY; CALIBRATORS AND CONTROLS Lin-Zhi International, Inc.
K063024 10/02/2006 LZI AMPHETAMINE-SPECIFIC ORAL FLUID HOMOGENEOUS ENZTME IMMUNOASSAY: LZI AMPHETAMINE ORAL FLUID CALIBRATORS AND CONTROLS Lin-Zhi International, Inc.
K040070 01/14/2004 ARTELON SPACER CMC-1 ARTIMPLANT AB
K030656 03/03/2003 ENVAN HEART RATE MONITOR ENVAN, LLC
K052482 09/09/2005 ARTELON SURGICAL SUTURE ARTIMPLANT AB
K093753 12/07/2009 MDPO FRAME SYSTEM MDPO, LLC
K063631 12/06/2006 POLYPERF / POLYPERF SAFE LABORATOIRES PEROUSE
K133406 11/06/2013 CS 8100 3D TROPHY
K140086 01/14/2014 PERSONAL KINETIGRAPH (PKG) SYSTEM GKC MANUFACTURING PTY LTD.
K141830 07/07/2014 STIMULAN KIT, STIMULAN RAPID CURE BIOCOMPOSITES LTD.
K082383 08/19/2008 FORTOSS VITAL BIOCOMPOSITES LTD.
K110326 02/03/2011 OSRAM ITOS OSRAM SYLVANIA, INC.
K982939 08/21/1998 BTF THIN FILM WOUND DRESSING BIODERM, INC.
K962337 06/17/1996 ELITYS OR ELITYS-E TROPHY RADIOLOGIE
K133097 09/30/2013 E-Z LINK DUOJECT MEDICAL SYSTEMS, INC.
K151061 04/20/2015 Cornea Cold EUROBIO
K202180 08/04/2020 Broncoflex Agile; Product Reference: 20030001 , Broncoflex Vortex; Product Reference: 10030001, Screeni; Product Reference: 30030001 Axess Vision Technology
K212886 09/10/2021 Broncoflex Agile, Broncoflex Vortex, Screeni Axess Vision Technology
K200183 01/24/2020 CS 9600 Trophy
K060292 02/06/2006 KODAK MODELS 2100 AND 2200 KODAK-TROPHY
K080889 03/31/2008 KODAK 9000C EXTRAORAL IMAGING SYSTEM TROPHY
K120975 04/02/2012 CS 8100 CS 8100 ACCESS TROPHY
K151087 04/23/2015 CS 8100SC, CS8100SC Access TROPHY
K991455 04/26/1999 ORTHOSLICE OS1000 SERIES; PANORAMIC ORTHOSLICE OS 1000: OS1000, OS1000E PANORAMIC AND CEPHALOMETRIC ORTHOSLICE OS1000C, TROPHY RADIOLOGIE
K181136 04/30/2018 CS 9600 Trophy
K961826 05/13/1996 DIGIPAN TROPHY RADIOLOGIE
K141607 06/16/2014 DENTAL IMAGING SOFTWARE TROPHY
K151837 07/06/2015 CS 3D Imaging TROPHY
K012514 08/06/2001 DIGIPAN / DPI TROPHY RADIOLOGIE
K082972 10/06/2008 KODAK 9500 TROPHY
K023346 10/07/2002 TROPHYPAN TROPHY RADIOLOGIE
K033419 10/27/2003 STV PRO 2 TROPHY RADIOLOGIE
K093478 11/09/2009 KODAK RVG 6500 SYSTEM AND KODAK RVG 6500 IPS SYSTEM TROPHY
K113419 11/18/2011 CS IMAGING TROPHY
K033690 11/24/2003 TROPHYPAN AND TROPHYPAN C TROPHY RADIOLOGIE
K173622 11/24/2017 CS Imaging Trophy
K073435 12/06/2007 KODAK 9000, KODAK 9000 3D TROPHY
K193390 12/06/2019 CS Model+ Trophy
K103659 12/15/2010 CS 9300, CS 9300C TROPHY
K220978 04/04/2022 TSX Implants Biomet 3i LLC
K071177 04/27/2007 ARTHREX BIO- COMPOSITE SUTURE ANCHORS: BIO-COMPOSITE PUSHLOCK, BIO-COMPOSITE TAK, BIO-COMPOSITE CORKSCREW ARTHREX, INC.
K071456 05/25/2007 ARTHREX PROSTOP PLUS ARTHROEREISIS SUBTALAR IMPLANT ARTHREX, INC.
K133342 10/30/2013 ARTHREX IBALANCE TKA SYSTEM ARTHREX, INC.
K201458 06/01/2020 Scrambler Therapy Technology (Model ST-5A) Delta International Services & Logistics S.r.l
K954996 11/01/1995 TREND AMEBIASIS (E.HISTOLYTICA) SEROLOGICAL ELISA TEST SYSTEM TREND SCIENTIFIC, INC.
K955755 12/20/1995 TREND CRYPTOSPORIDIUM DETECTION TEST SYSTEMS TREND SCIENTIFIC, INC.
K152646 09/16/2015 SYLK PERSONAL LUBRICANT TORO MANAGEMENT LLC DBA SYLK
K221696 06/10/2022 ReWalk P6.0 ReWalk Robotics Ltd.


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