FDA 510(k) Applications Submitted by LI LE

FDA 510(k) Number Submission Date Device Name Applicant
K141679 06/23/2014 JUSHA-C61 LCD MONITOR NANJING JUSHA DISPLAY TECHNOLOGY CO., LTD
K141684 06/23/2014 JUSHA-C33C LCD MONITOR NANJING JUSHA DISPLAY TECHNOLOGY CO., LTD
K141690 06/23/2014 JUSHA-M33C LCD MONITOR NANJING JUSHA DISPLAY TECHNOLOGY CO., LTD
K220058 01/06/2022 BeneVision Central Monitoring System Shenzhen Mindray Bio-Medical Electronics Co., LTD
K221113 04/15/2022 Accutorr 3 Vital Signs Monitor, Rosebud Vital Signs Monitor Shenzhen Mindray Bio-Medical Electronics Co., LTD
K221267 05/02/2022 VS 8 Vital Signs Monitor, VS 8A Vital Signs Monitor, VS 9 Vital Signs Monitor Shenzhen Mindray Bio-Meidcal Electronics Co., LTD
K213799 12/06/2021 N Series Patient Monitors Shenzhen Mindray Bio-medical Electronics Co., LTD.
K151236 05/11/2015 MiniMed Connect kit, MiniMed Connect uploader, MiniMed Connect app, CareLink Connect (CareLink Personal) MEDTRONIC MINIMED, INC.
K973059 08/18/1997 PATIENT NITRILE EXAMINATION GLOVE (LIGHTLY POWDERED) SRI JOHANI SDN. BHD.
K973058 08/18/1997 PATIENT NITRILE EXAMINATION GLOVE (POWDERFREE) SRI JOHANI SDN. BHD.
K973903 10/14/1997 POWDERFREE NITRILE EXAMINATION GLOVES (BLUE COLOUR) SRI JOHANI SDN. BHD.
K973904 10/14/1997 POLYMER LATEX EXAMINATION GLOVES SRI JOHANI SDN. BHD.
K955888 12/29/1995 PREPOWDERED LATEX EXAMINATION GLOVES PANTAI UTAMA SDN. BHD.
K955889 12/29/1995 POWDERFREE LATEX EXAMINATION GLOVES PANTAI UTAMA SDN. BHD.
K993458 10/13/1999 POWDERED LATEX EXAMINATION GLOVES (PROTEIN LABEL CLAIM) SRI JOHANI SDN. BHD.
K993457 10/13/1999 POWDERFREE LATEX EXAMINATION GLOVES (PROTEIN LABEL CLAIM) [50 MICROGRAMS OR LESS] SRI JOHANI SDN. BHD.
K993454 10/13/1999 POWDERFREE LATEX EXAMINATION GLOVES (POLYMER COATED) (PROTEIN LABEL CLAIM - 50 MICROGRAMS OR LESS) SRI JOHANI SDN. BHD.
K974183 11/06/1997 POLYMER NITRILE EXAMINATION GLOVES (BLUE COLOUR) SRI JOHANI SDN. BHD.
K974185 11/06/1997 POLYMER NITRILE EXAMINATION GLOVES SRI JOHANI SDN. BHD.
K974182 11/06/1997 POWDERED NITRILE EXAMINATION GLOVES (BLUE COLOUR) SRI JOHANI SDN. BHD.
K974184 11/06/1997 HIGH RISK POLYMER LATEX EXAMINATION GLOVES (BLUE COLOUR) SRI JOHANI SDN. BHD.
K974886 12/30/1997 POWDERED GREEN NITRILE EXAMINATION GLOVES SRI JOHANI SDN. BHD.
K974887 12/30/1997 POWDERFREE GREEN NITRILE EXAMINATION GLOVES SRI JOHANI SDN. BHD.
K981062 03/23/1998 POLYMER COATED, POWDER-FREE LATEX EXAMINATION GLOVES IDEAL QUALITY SDN., BHD.
K003084 10/03/2000 CONCENTRIC HYDROPHILIC GUIDEWIRE, MODELS 90011, 90012 CONCENTRIC MEDICAL, INC.
K003085 10/03/2000 CONCENTRIC GUIDE CATHETER, MODELS 90018, 90020 CONCENTRIC MEDICAL, INC.
K023445 10/15/2002 TRACERS BONE CEMENT OPACIFIER PARALLAX MEDICAL, INC.
K050021 01/05/2005 VASCULAR SOLUTIONS VARI-LASE ENDOVENOUS LASER PROCEDURE KIT VASCULAR SOLUTIONS, INC.
K050133 01/21/2005 D-STAT RADIAL HEMOSTATIC BAND VASCULAR SOLUTIONS, INC.
K050146 01/24/2005 VASCULAR SOLUTIONS D-STAT CLAMP ACCESSORY VASCULAR SOLUTIONS, INC.
K050511 03/01/2005 THROMBIGEL THROMBIN/GELATIN FOAM HEMOSTAT VASCULAR SOLUTIONS, INC.
K200513 03/02/2020 DAC Dynamic Active Compression Plate Pioneer Surgical Technology, Inc., DBA RTI Surgical
K051287 05/18/2005 VARI-LASE ENDOVENOUS LASER PROCEDURE KIT VASCULAR SOLUTIONS, INC.
K192718 09/27/2019 Fortilink Interbody Fusion Device (IBF) with TETRAfuse 3D Technology Pioneer Surgical Technology, Inc., DBA RTI Surgical, Inc.
K053054 10/31/2005 THROMBIX 3X3 HEMOSTATIC PAD VASCULAR SOLUTIONS, INC.
K193468 12/16/2019 Tritium Sternal Cable Plate System Pioneer Surgical Technology, Inc. (dba RTI Surgical, Inc.)
K053644 12/30/2005 THROMBIGEL THROMBIN/GELATIN FOAM HEMOSTAT VASCULAR SOLUTIONS, INC.
K982672 07/31/1998 COLLEAGUE PUMP SYRINGE ADAPTER SET BAXTER HEALTHCARE CORP.
K983294 09/21/1998 ALL-IN-ONE CONTAINER CAT#'S 2B8114,2B8124, 2B8134, 2B8144, 2B8102, 2B8152, 2B8112, 2B8117M 2B8122, 2B8132, 2B8142, 2B712 BAXTER HEALTHCARE CORP.
K003245 10/17/2000 HEPARIN LOCK FLUSH SYRING 10 USP UNITS/ML, HEPARIN LOCK FLUSH SYRINGE, 100 USP UNITS/ML BAXTER HEALTHCARE CORP.
K010059 01/08/2001 ENGPLUS WESTERN SYSTEMS RESEARCH, INC.
K130186 01/25/2013 DENTEK EASY BRUSH WITH FLUORIDE DENTEK ORAL CARE, INC.
K151149 04/30/2015 Ready-Fit DENTEK ORAL CARE, INC.
K123849 12/14/2012 NEW COMFORT-FIT DENTAL GUARD DENTEK ORAL CARE, INC.
K972674 07/16/1997 WILSON-COOK NEEDLE KNIFE PAPILLOTOME WILSON-COOK MEDICAL, INC.
K052965 10/21/2005 EASYTRAK 2 STYLET, MODELS 4826, 4829, 4832. GUIDANT CORPORATION
K070165 01/18/2007 ENSEAL PTC TRIO SURGRX, INC.
K050671 03/15/2005 ENSEAL VESSEL SEALING & HEMOSTASIS SYSTEM SURGRX, INC.
K070896 04/02/2007 ENSEAL PTC TISSUE SEALING DEVICE SURGRX, INC.
K031133 04/09/2003 SURGRX ENSEAL VESSEL SEALING AND HEMOSTASIS SYSTEM INCLUDING THE ENSEAL CONTROLLER ADAPTER, ENSEAL OPEN AND LAPAROSCOPIS SURGRX INC
K081129 04/21/2008 ENSEAL POWERTIP,NSEAL-514D,-525D,-535D,-545D,-514RD,-525RD,-535RD,-545RD, ETRIO-314D,-325D,-335D,-345D, ENSEAL UNIVERSAL SURGRX, INC.
K061526 06/02/2006 ENSEAL PTC TISSUE SEALING DEVICE SURGRX INC
K071728 06/25/2007 MODIFICATION TO: ENSEAL PTC TISSUE SEALING DEVICE SURGRX, INC.
K072177 08/06/2007 ENSEAL VESSEL SEALING AND HEMOSTASIS SYSTEM SURGRX, INC.
K072493 09/05/2007 ENSEAL TISSUE SEALING DEVICE SURGRX INC
K062949 09/29/2006 ENSEAL PTC TISSUE SEATING SEALING DEVICE SURGRX INC
K063097 10/10/2006 ENSEAL PTC TISSUE SEALING DEVICE SURGRX, INC.
K043008 11/01/2004 SURGRX ENSEAL VESSEL SEALING & HEMOSTASIS SYSTEM SURGRX, INC.
K210126 01/19/2021 Sodium Chloride Inhalation Solutions, 3%, 3.5%, 7% and 10% The Ritedose Corporation
K000861 03/17/2000 CRANIOCAP GILLETTE CHILDREN'S SPECIALTY HEALTHCARE
DEN050007 06/20/2005 HEALTHCHECK(TM) HOME TEST FOR LOSS OF THE SENSE OF SMELL FMG INNOVATIONS, INC.
K011723 06/04/2001 ANTI-SNORING DEVICE OR ASD PI MEDICAL
K190875 04/04/2019 EVA, anterior machine, EVA, combined machine, EVA combined machine with laser (DORC connector), EVA combined machine with laser (SMA connector) D.O.R.C. Dutch Ophthalmic Research Center (International)
K213467 10/28/2021 EVA NEXUS Ophthalmic Surgical System D.O.R.C. Dutch Ophthalmic Research Center (International)
K112832 09/29/2011 EYE CARE CURE CONTACT LENS CASE EYE CARE AND CURE
K100147 01/19/2010 S4 CERVICAL OCCIPITAL PLATE SPINAL SYSTEM AESCULAP IMPLANT SYSTEM, INC.
K060152 01/20/2006 MODIFICATION TO S4 SPINAL SYSTEM AESCULAP, INC.
K100243 01/27/2010 QUINTEX CERVICAL PLATING SYSTEM AESCULAP IMPLANT SYSTEMS, LLC
K110864 03/29/2011 BIOSPINE VBR SYSTEM AESCULAP IMPLANT SYSTEMS, LLC
K070981 04/06/2007 SEARCH EVOLUTION (LC) TOTAL KNEE SYSTEM (PLASMAPORE) AESCULAP IMPLANT SYSTEMS, INC.
K080992 04/07/2008 AESCULAP IMPLANT SYSTEMS HIGH TIBIAL OSTEOTOMY PLATING SYSTEM AESCULAP IMPLANT SYSTEMS, INC.
K081031 04/11/2008 ENDOSCOPIC CLIP APPLIERS WITH CLIP MAGAZINE AESCULAP, INC.
K061424 05/23/2006 CELSITE/ CELSITE CONCEPT, ACCESS PORTS AESCULAP, INC.
K031761 06/06/2003 SYNTHES (USA) NEW/STERIAL ORBITAL PLATES SYNTHES (USA)
K041533 06/08/2004 SYNTHES (USA) [SYNTHES} PERI-PROSTHETIC SCREWS SYNTHES (USA)
K121801 06/19/2012 QUINTEX CERVICAL PLATING SYSTEM AESCULAP IMPLANT SYSTEMS, LLC
K172032 07/05/2017 Modulift Vertebral Body Replacement (VBR) System Aesculap Implants Systems, Inc.
K221947 07/05/2022 Tyber Medical Staple Fixation System (various) Tyber Medical, LLC.
K151938 07/14/2015 S4 Cervical Spinal and Occiput Systems AESCULAP IMPLANT SYSTEMS, LLC
K222465 08/15/2022 Tyber Medical Anatomical Plating System Tyber Medical, LLC
K052390 08/31/2005 SYNTHES LCP PROXIMAL TIBIA PLATES LINE EXTENSION SYNTHES (USA)
K172850 09/20/2017 SterilContainer with PrimeLine Pro Lid Aesculap, Inc.
K052683 09/28/2005 SYNTHES (USA) STERNAL FIXATION SYSTEM SYNTHES (USA)
K083004 10/08/2008 MILI (MINIMALLY INVASIVE LUMBAR IMPLANT) SYSTEM AESCULAP IMPLANT SYSTEMS, INC.
K053199 11/16/2005 SYNTHES PATIENT SPECIFIC CRANIAL/CRANIOFACIAL IMPLANT SYNTHES (USA)
K170570 02/27/2017 Anchored Beacon(R) transponder, Anchored transponder, Beacon Care Package - Lung Varian Medical Systems Inc
K140823 04/01/2014 PERMANENT BEACON TRANSPONDER/SOFT TISSUE BEACON TRANSPONDER VARIAN MEDICAL SYSTEMS, INC.
K202326 08/17/2020 BESPA Charcot System Bespa Global, LLC
K021366 04/30/2002 MAC-LAB/CARDIOLAB EP/COMBOLAB GENERAL ELECTRIC MEDICAL SYSTEMS INFORMATION TECHN
K021470 05/08/2002 SEER LIGHT COMPACT DIGITAL HOLTER RECORDER GENERAL ELECTRIC MEDICAL SYSTEMS INFORMATION TECHN
K023100 09/18/2002 ACCUSKETCH CARDIAC QUANTITATIVE SYSTEM W/ ADVANCED ANALYSIS COMPONENTS GENERAL ELECTRIC MEDICAL SYSTEMS INFORMATION TECHN
K033492 11/04/2003 MODIFICATION TO MAC 5000 ECG ANALYSIS SYSTEM GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES
K014108 12/13/2001 MAC 5000 ECG ANALYSIS SYSTEM GENERAL ELECTRIC MEDICAL SYSTEMS INFORMATION TECHN
K050041 01/07/2005 SYNTHES (USA) STERILE STERNAL FIXATION SYSTEM SYNTHES (USA)
K040083 01/15/2004 SYNTHES EXTERNAL MIDFACE DISTRACTOR SYNTHES (USA)
K030310 01/30/2003 SYNTHES STAINLESS STEEL MODULAR HAND SYSTEM SYNTHES (USA)
K040272 02/05/2004 SYNTHES (USA) CRANIOFACIAL PLATES SYNTHES (USA)
K130291 02/06/2013 S4 SPINAL SYSTEM AESCULAP IMPLANT SYSTEM, INC.
K090354 02/11/2009 LAMINOPLASTY PLATING SYSTEM AESCULAP IMPLANT SYSTEM, INC.
K090375 02/17/2009 ORTHOPILOT NEXT GENERATION-UKA SOFTWARE, MODEL FS210 AESCULAP IMPLANT SYSTEM, INC.
K030597 02/25/2003 SYNTHES 3.5MM TITANIUM LCP PROXIMAL TIBIA PLATES SYNTHES (USA)
K100623 03/04/2010 AESCULAP IMPLANT SYSTEMS S4 SPINAL SYSTEM AESCULAP IMPLANT SYSTEMS
K040588 03/05/2004 SYNTHES (USA) 2.4 MM LCP WRIST PLATE SYNTHES (USA)
K090657 03/12/2009 MODIFICATION TO: S4 SPINAL SYSTEM AESCULAP IMPLANT SYSTEMS
K110695 03/14/2011 BIPOLAR HF DEVICE AESCULAP, INC.
K080753 03/17/2008 AESCULAP ENDOSCOPIC CLIP SYTEM AESCULAP, INC.
K030858 03/18/2003 SYNTHES (USA) LCP PROXIMAL FEMUR PLATE AND SCREWS SYNTHES (USA)
K100802 03/22/2010 AESCULAP IMPLANT SYSTEMS SIBD SPINAL SYSTEM AESCULAP IMPLANT SYSTEMS, INC.
K040765 03/25/2004 SYNTHES 5.0/7.3 MM CANNULATED LOCKING SCREWS SYNTHES (USA)
K040777 03/26/2004 LCP RADIAL HEAD PLATING SYSTEM SYNTHES (USA)
K130887 03/29/2013 S4C NAVIGATION INSTRUMENTS AESCULAP IMPLANT SYSTEM, INC.
K031178 04/14/2003 SYNTHES (USA) 3.5 MM BROAD LCP & 4.5 MM LCP DISTAL HUMERUS PLATES SYNTHES (USA)
K111122 04/21/2011 AESCULAP SIBD XP SPINAL SYSTEM AESCULAP IMPLANT SYSTEMS, INC.
K081293 05/07/2008 UNIVATION UNICONDYLAR KNEE SYSTEM AESCULAP IMPLANT SYSTEMS, INC.
K031508 05/14/2003 SYNTHES (USA) STERNAL RECONSTRUCTION SYSTEM SYNTHES (USA)
K031555 05/19/2003 SYNTHES (USA) COMPARTMENTAL PRESSURE MONITORING SYSTEM SYNTHES (USA)
K041333 05/19/2004 SYNTHES (USA) TITANIUM WIRE SYNTHES (USA)
K091692 06/10/2009 AESCULAP PEEK CRANIOFIX AESCULAP, INC.
K041611 06/15/2004 SYNTHES (USA) RAPID RESORBABLE CRANIAL CLAMP SYNTHES (USA)
K061704 06/16/2006 OPTILENE MESH AESCULAP, INC.
K061699 06/16/2006 EXCIA AESCULAP, INC.
K032032 07/01/2003 SYNTHES (USA) LCP PROXIMAL FEMUR HOOK PLATES SYNTHES (USA)
K041887 07/12/2004 SYNTHES (USA) 1.0/1.22 MM CRANIOFACIAL SCREWS SYNTHES (USA)
K041911 07/15/2004 SYNTHES (USA) LCP CURVED PLATES SYNTHES (USA)
K062012 07/17/2006 S4 CERVICAL OCCIPITAL PLATE SPINAL SYSTEM AESCULAP, INC.
K032269 07/23/2003 SYNTHES (USA) 3.5/4.5MM LCP MEDIAL PROXIMAL TIBIA PLATES SYNTHES (USA)
K132421 08/05/2013 AESCULAP PEEK XP SPINAL IMPLANT SYSTEM AESCULAP IMPLANT SYSTEMS, INC.
K142150 08/05/2014 AIS MODULIFT VBR SYSTEM AESCULAP IMPLANT SYSTEM, INC.
K042135 08/09/2004 SYNTHES (USA) ELASTIC INTRAMEDULLARY NAIL (EIN) SYSTEM (LINE EXTENSION) SYNTHES (USA)
K062327 08/10/2006 MODIFICATION TO S4 SPINAL SYSTEM AESCULAP, INC.
K062406 08/17/2006 AESCULAP NEURO PATTIES AESCULAP, INC.
K032559 08/19/2003 SYNTHES 4.0MM TITANIUM (TI.) LOCKING SCREWS SYNTHES (USA)
K042356 08/31/2004 SYNTHES 1.0/1.2 MM PLUSDRIVE SCREWS SYNTHES (USA)
K042377 09/01/2004 SYNTHES LOW PROFILE RECONSTRUCTION PLATES SYNTHES (USA)
K112551 09/01/2011 S4 SPINAL SYSTEM AESCULAP IMPLANT SYSTEM, INC.
K052483 09/09/2005 SYNTHES (USA) SPHERICAL WASHERS SYNTHES (USA)
K142707 09/22/2014 AIS Odontoid Fracture Fixation System AESCULAP IMPLANT SYSTEM, INC.
K033071 09/29/2003 SYNTHES (USA) CANNULATED TITANIUM HUMERAL NAIL SYSTEM SYNTHES (USA)
K033121 09/30/2003 1.3 & 1.5MM CONTOURABLE TITANIUM (TI.) MESH PLATES SYNTHES (USA)
K033160 09/30/2003 SYNTHES STERILE LOW PROFILE NEURO CONTOURABLE MESH PLATES SYNTHES (USA)
K042987 10/29/2004 MODIFICATION TO SYNTHES CRANIAL PLATES SYNTHES (USA)
K042986 10/29/2004 MODIFICATION TO SYNTHES (USA) (SYNTHES) LOW PROFILE NEURO SYSTEM SYNTHES (USA)
K123352 10/31/2012 S4 SPINAL SYSTEM AESCULAP IMPLANT SYSTEMS, INC.
K053105 11/04/2005 SYNTHES (USA) ELASTIC INTRAMEDULLARY NAIL (EIN) END CAP SYNTHES (USA)
K103284 11/05/2010 LAMINOPLASY PLATING SYSTEM AESCULAP IMPLANT SYSTEMS, INC.
K023802 11/14/2002 SYNTHES 4.5 MM TITANIUM LCP PROXIMAL TIBIA PLATING SYSTEM SYNTHES (USA)
K043185 11/17/2004 SYNTHES 3.5MM CORTEX SCREWS SYNTHES (USA)
K023879 11/21/2002 SMALL TITANIUM WRIST FUSION PLATE SYNTHES (USA)
K023941 11/26/2002 SYNTHES TOMOFIX OSTEOTOMY SYSTEM SYNTHES (USA)
K043310 12/01/2004 SYNTHES (USA) ELECTRIC PEN DRIVE SYSTEM SYNTHES (USA)
K033805 12/08/2003 SYNTHES (USA) 3.5 / 4.5 MM LCP METAPHYSEAL PLATES SYNTHES (USA)
K033816 12/09/2003 SYNTHES (USA) MODIFICATION TO STERNAL RECONSTRUCTION SYSTEM SYNTHES (USA)
K033868 12/12/2003 SYNTHES (USA) PATIENT SPECIFIC CRANIAL/CRANIOFACIAL IMPLANTS SYNTHES (USA)
K133802 12/13/2013 AIS MODULIFT VBR SYSTEM AESCULAP IMPLANT SYSTEM, INC.
K083772 12/18/2008 COLUMBUS REVISION KNEE SYSTEM AESCULAP IMPLANT SYSTEM, INC.
K153629 12/18/2015 ArcadiusXP C Spinal System Aesculap Implant Systems, Inc.
K123909 12/19/2012 AESCULAP CESPACE XP AESCULAP IMPLANT SYSTEM, INC.
K123939 12/20/2012 S4 SPINAL SYSTEM AESCULAP IMPLANT SYSTEMS, INC.
K033975 12/23/2003 SYNTHES 2.4 MM TITANIUM (TI.) LOCKING SCREWS SYNTHES (USA)
K033995 12/24/2003 3.5 MM LCP DISTAL HUMERUS SYSTEM SYNTHES (USA)
K151056 04/20/2015 Aesculap T-Space PEEK and XP Spinal System AESCULAP IMPLANT SYSTEMS, LLC
K052131 08/05/2005 EXPEDIUM SPINE SYSTEM 5.5MM COMMERICALLY PURE TITANIUM SPINAL RODS DEPUY SPINE, INC.
K052552 09/16/2005 HYBRID ANTERIOR CERVICAL PLATE SYSTEM DEPUY SPINE, INC.


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