FDA 510(k) Applications Submitted by S F CHO

FDA 510(k) Number Submission Date Device Name Applicant
K102790 09/27/2010 POWDER FREE NITRILE PATIENT EXAMINATION GLOVE, BLUE COLORED NON-STERILE (LOW DERAMATITIS POTENTIAL AND CHEMOTHERAPY DRUG PERUSAHAAN GETAH ASAS SDN BHD
K960616 02/13/1996 VITAFLOW SUCTION/ASPIRATION TUBING SET VITAL CONCEPTS, INC.
K143411 11/28/2014 TRAUS ENDO SAESHIN PRECISION CO., LTD.
K151171 05/01/2015 TRAUS SUS10 SAESHIN PRECISION CO., LTD.
K234113 12/27/2023 MiiS Horus Bronchoscope; MiiS Horus Endoscope Display System -Tablet; MiiS Horus Endoscope Display System -Video Box Medimaging Integrated Solution, Inc. (MiiS)
K193498 12/17/2019 Infinitt RT PACS Infinitt Healthcare Co.,Ltd.
K172803 09/18/2017 Infinitt PACS 7.0 Infinitt Healthcare Co.,Ltd.
K193369 12/05/2019 Xelis Dental 2.0 Infinitt Healthcare Co.,Ltd.
K211432 05/07/2021 Myomics Q Phantomics Inc.
K241160 04/26/2024 CAIs Sensor (CAIs-001) BrainU Co.,Ltd.
K250266 01/30/2025 Ceragem Automatic Thermal Massager (CGM MB-2401) CERAGEM Co, Ltd.
K230340 02/07/2023 Lucas Plus AMT Engineering Co., Ltd
K241672 06/11/2024 COPRO 3 AMT Engineering Co., Ltd
K183352 12/03/2018 Optimus Neuro System Osteonic Co., Ltd
K190564 03/05/2019 Rightest Blood Glucose Monitoring System GM700S, Rightest Blood Glucose Monitoring System GM700SB Bionime Corporation
K182034 07/30/2018 Arterys MICA Arterys Inc.
K192437 09/06/2019 Arterys MICA Arterys Inc.
K213007 09/20/2021 Cerebra Sleep System Cerebra Medical Ltd.
K203744 12/22/2020 Arterys MICA Arterys Inc.
K070091 01/10/2007 COAXIAL BONE AND VERTEBRAL BODY BIOPSY NEEDLE MODEL# JBC1213, JBC1208 CARDINAL HEALTH, INC.
K040152 01/23/2004 BONE CEMENT FOR CRANIOPLASTY Cardinal Health
K090211 01/28/2009 INFLATABLE BONE TAMP CARDINAL HEALTH, INC.
K170378 02/07/2017 AirLife Adult Heated Wire BiPAP/NIV Circuit Vyaire Medical
K050994 04/19/2005 AIRLIFE INFANT NASAL CONTINUOUS POSITIVE AIRWAY PRESSURE SYSTEM Cardinal Health
K091250 04/28/2009 DIAGNOSTIC CATHETER SYSTEM CARDINAL HEALTH, INC.
K051226 05/12/2005 AIRLIFE NASAL CONTINUOUS POSITIVE AIRWAY PRESSURE (NCPAP) SYTEM DRIVER Cardinal Health
K201919 07/10/2020 Blue Sky Bio TAD Blue Sky Bio, LLC.
K072119 08/01/2007 AIRLIFE NEBULIZER CAP Cardinal Health
K072133 08/02/2007 AVAFLEX VERTEBRAL AUGMENTATION NEEDLE CARDINAL HEALTH, INC.
K032388 08/04/2003 BONE CEMENT RADIO-OPACIFIER Cardinal Health
K092684 09/01/2009 LAPAROSCOPIC RETRACTORS CARDINAL HEALTH, INC.
K023167 09/23/2002 BREATHABLE SURGICAL GOWN ALLEGIANCE HEALTHCARE CORP.
K023425 10/11/2002 DRAPES WITH ABSORBENT REINFORCEMENT ALLEGIANCE HEALTHCARE CORP.
K023419 10/11/2002 TRILAMINATE DRAPES/TIBURON ALLEGIANCE HEALTHCARE CORP.
K023602 10/28/2002 SMALL VOLUME NEBULIZER ALLEGIANCE HEALTHCARE CORPORATION
K023673 11/01/2002 AIRLIFE DEMAND NASAL CANNULA ALLEGIANCE HEALTHCARE CORP.
K093463 11/06/2009 AVAMAX VERTEBRAL BALLOON MODEL VBS1010, VBS1015, VBS1020 CAREFUSION
K024120 12/16/2002 MODIFICATION TO TEMNO BIOPSY NEEDLES ALLEGIANCE HEALTHCARE CORP.
K043518 12/20/2004 RADIOPAQUE BONE CEMENT Cardinal Health
K220286 02/01/2022 ELECTROCYN soma V3bio Sdn. Bhd
K142775 09/26/2014 Neuwater TM (HydrocynTM aqua) Vigilenz Medical Devices
K024089 12/11/2002 VACUFLASH BIOPSY SYSTEM BIP USA, INC.
K210034 01/06/2021 EnsoSleep EnsoData, Inc.
K231355 05/10/2023 Aurora EnsoData
K152186 08/05/2015 HealthMyne PACS HEALTHMYNE, INC.
K242748 09/12/2024 Oncospace Oncospace, Inc.
K222803 09/16/2022 Oncospace Oncospace, Inc.
K153289 11/13/2015 HEALTHMYNE HEALTHMYNE, INC
K070464 02/16/2007 ONDEMAND3D CYBERMED, INC.
K061126 04/24/2006 ACCUREX CYBERMED, INC.
K053155 11/14/2005 VIMPLANT CYBERMED, INC.
K152270 08/11/2015 Denture base resin KOREA ENGINEERING PLASTICS CO., LTD.
K211780 06/09/2021 ZEN-2090 Turbo Genoray Co., Ltd.
K121362 05/07/2012 1.5T 16CH FLEX SPEEDER LARGE NEOCOIL, LLC
K113474 11/22/2011 1.5T GEM FLEX COIL NEOCOIL, LLC
K100615 03/04/2010 ARSTASIS ACCESS SYSTEM ARSTASIS, INC.
K060974 04/10/2006 RELIENT NAVIGATION DEVICE ACCLARENT, INC.
K052198 08/12/2005 RELIEVA SINUS BALLOON INFLATION DEVICE ACCLARENT, INC.
K130328 02/11/2013 F&P SIMPLUS FULL FACE MASK FISHER & PAYKEL HEALTHCARE LIMITED
K172140 07/17/2017 NovoSorb BTM Wound Dressing (2cm x 2cm), NovoSorb BTM Wound Dressing (10cm x 10cm), NovoSorb BTM Wound Dressing (10cm x 20cm), NovoSorb BTM Wound Dressing (20cm x 40cm) PolyNovo Biomaterials Pty Ltd
K153505 12/07/2015 F&P Eson 2 Nasal Mask FISHER & PAYKEL HEALTHCARE LIMITED
K212144 07/09/2021 Remex KA6 Remedi Co. Ltd.
K180039 01/05/2018 ACUSON Juniper Diagnostic Ultrasound System Siemens Medical Solutions USA, Inc.
K180067 01/09/2018 ACUSON X800 Diagnostic Ultrasound System Siemens Medical Solutions USA, Inc.
K230207 01/25/2023 ACUSON Juniper Diagnostic Ultrasound System, ACUSON Juniper Select Diagnostic Ultrasound System Siemens Medical Solutions USA, Inc.
K210743 03/12/2021 ACUSON Redwood Diagnostic Ultrasound System Siemens Medical Solutions USA, Inc
K200707 03/18/2020 ACUSON Sequoia Diagnostic Ultrasound System Siemens Medical Solutions USA, Inc
K221190 04/25/2022 ACUSON Juniper Diagnostic Ultrasound System and ACUSON Juniper Select Diagnostic Ultrasound System Siemens Medical Solutions USA, Inc.
K221500 05/23/2022 ACUSON Sequoia Diagnostic Ultrasound System Siemens Medical Solutions USA, Inc
K201462 06/02/2020 ACUSON Sequoia Diagnostic Ultrasound System Siemens Medical Solutions USA, Inc
K211859 06/16/2021 ACUSON Sequoia Diagnostic Ultrasound System Siemens Medical Solutions USA, Inc
K232145 07/19/2023 ACUSON Sequoia Diagnostic Ultrasound System, ACUSON Sequoia Select Diagnostic Ultrasound System, ACUSON Origin Diagnostic Ultrasound System Siemens Medical Solutions USA, Inc.
K242523 08/23/2024 ACUSON Sequoia Diagnostic Ultrasound System; ACUSON Sequoia Select Diagnostic Ultrasound System; ACUSON Origin Diagnostic Ultrasound System; ACUSON Origin ICE Diagnostic Ultrasound System Siemens Medical Solutions USA, Inc.
K213487 10/29/2021 ACUSON P500 Ultrasound System Siemens Medical Solutions USA, Inc.
K193257 11/26/2019 ACUSON Sequoia Diagnostic Ultrasound System Siemens Medical Solutions USA, Inc
K223735 12/13/2022 ACUSON Sequoia Diagnostic Ultrasound System, ACUSON Sequoia Select Diagnostic Ultrasound System Siemens Medical Solutions USA, Inc
K163635 12/22/2016 ACUSON S1000/S2000/S3000 Diagnostic Ultrasound Systems Siemens Medical Solutions USA, Inc. Ultrasound Group
K173957 12/28/2017 ACUSON NX3 Diagnostic Ultrasound System; ACUSON NX3 ELITE Diagnostic Ultrasound System Siemens Medical Solutions USA, Inc.
K173981 12/29/2017 ACUSON NX2 Diagnostic Ultrasound System, ACUSON NX2 Elite Diagnostic Ultrasound System Siemens Medical Solutions USA, Inc. Ultrasound Group
K170039 01/05/2017 STERRAD VELOCITY Biological Indictator and Reader Advanced Sterilization Products (ASP)
K141693 06/24/2014 Tyvek« Pouch/Roll with STERRAD« Chemical Indicator ADVANCED STERILIZATION PRODUCTS
K151725 06/26/2015 STERRAD NX Sterilizer, STERRAD 100NX Sterilizer ADVANCED STERILIZATION PRODUCTS
K151971 07/16/2015 STERRAD CYCLESURE 24 Biological Indicator ADVANCED STERILIZATION PRODUCTS
K142454 09/02/2014 STERRAD NX Sterilizer, STERRAD 100NX Sterilizer ADVANCED STERILIZATION PRODUCTS
K182404 09/04/2018 STERRAD VELOCITY Biological Indicator Advanced Sterilization Products (ASP)
K091725 06/11/2009 PERFIX SPINAL SYSTEM, MODEL SNA4530-9610, SNM4530-9610, SN3020 (TOTAL: 549) U&I CORP.
K173141 09/29/2017 CSM Submerged3-L Implant System CSM Implant
K240759 03/20/2024 REMEX-GR100 Remedi Co., Ltd.
K151719 06/25/2015 REVE134 KW EAR LAB, INC
K081522 05/30/2008 BIO NUCLEAR DIAGNOSTICS (ENDO)CERVICAL SAMPLER FOR GYN CYTOLOGY BIO NUCLEAR DIAGNOSTICS, INC.
K111117 04/21/2011 CANNON II PLUS CHRONIC HEMODIALYSIS CATHETER, EDGE CHRONIC HEMODIALYSIS CATHETER, NEXTSTEP(R) RETROGRADE CHRONIC... Teleflex Medical, Inc.
K041740 06/28/2004 SILICONE COATED GUIDEWIRE ARROW INTERNATIONAL, INC.
K111900 07/05/2011 NEXTSTEP ANTEGRADE CHRONIC HEMODIALYSIS CATHETER Teleflex Medical, Inc.
K042126 08/06/2004 PICC ARROW INTL., INC.
K102238 08/09/2010 ARROW(R) NEXTSTEP TM ANTEGRADE CHRONIC HEMODIALYSIS CATHETER Teleflex Medical, Inc.
K070234 01/16/2007 JMS SYSLOC MINI AVF AND APHERESIS NEEDLE SETS JMS NORTH AMERICA CORP.
K032977 09/24/2003 JMS BYPASS TUBE JMS NORTH AMERICA CORP.
K023668 10/31/2002 JMS EXTENSION SET WITH PLANECTA, PLANECTA (STAND ALONE UNIT), PLANECTA LOCK & PLANECTA ADAPTOR JMS NORTH AMERICA CORP.


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